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1. Training Healthcare Professionals to Be Ready for Practice in an Era of Social Distancing: A Realist Evaluation

Author

Janet Lefroy, Jessica Bialan, Alice Moult, Fiona Hay, Claire Stapleton, Jessica Thompson, Kate Diggory, Nageen Mustafa, Julia Farrington, Sarah A. Aynsley, Simon Jacklin, Adam Winterton, and Natalie Cope

Abstract

Background: Programme changes due to the COVID-19 pandemic have impacted variably on preparation for practice of healthcare professional students. Explanations for such variability need exploration. The aim of our study was to understand what clinical learning, whilst under socially distanced restrictions, worked and why (or why not). Methods: We conducted a realist evaluation of the undergraduate healthcare programmes at one UK university in 2020-21. Initial programme theories to be tested in this study were derived from discussions with programme leads about the changes they implemented due to the pandemic. Study participants were students and teaching faculty. Online interview transcripts were coded, identifying why interventions had worked or not. This resulted in a set of 'context-mechanism-outcome' (CMO) statements about each intervention. The initial programme theories were refined as a result. Results and discussion: 29 students and 22 faculty members participated. 18 CMO configurations were identified relating to clinical skills learning and 25 relating to clinical placements. Clinical skills learning was successful whether in person, remote or hybrid if it followed the steps of: demonstration-explanation-mental rehearsal-attempt with feedback. Where it didn't work there was usually a lack of observation and corrective feedback. Placements were generally highly valued despite some deficiencies in student experience. Being useful on placements was felt to be good preparation for practice. If student numbers are to expand, findings about what works in distance learning of clinical skills and the value of various modes of induction to clinical workplace activity may also be relevant post-pandemic.

Published
2024
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2. Study of the measurement and predictive validity of the Functional Movement Screen

Author

Fraser Philp, Dimitra Blana, Edward K Chadwick, Caroline Stewart, Claire Stapleton, Kim Major, and Anand D Pandyan

Subjects
Medicine (General), R5-920
Abstract

Objective The aim of the study was to evaluate the reported measurement capabilities and predictive validity of the Functional Movement Screen (FMS) for injury.Methods This was a prospective observational longitudinal study of 24 male footballers from a single team in England, alongside analysis of an existing database over one season (September 2015–May 2016). A preseason FMS was carried out with scores recorded by an experienced assessor and derived, retrospectively, from the three-dimensional movement data that were simultaneously captured. The assessor scores were compared with the photogrammetric system to determine measurement validity, and predictive validity was quantified by assessing sensitivity and specificity (cut-off score of 14).Results The real-time assessor score matched the photogrammetric score awarded for one of the participants, was higher than the photogrammetric system for 22 participants and was lower than the photogrammetric system in 1 participant. There was no discernible relationship between FMS scores and the competencies required to be met as per the rules articulated for the allocation of a score. A higher number of total injuries were associated with higher FMS scores, whether determined through real-time assessment or codification of kinematic variables. Additionally, neither method of score determination was able to prospectively identify players at risk of serious injury.Conclusion The FMS does not demonstrate the properties essential to be considered as a measurement scale and has neither measurement nor predictive validity. A possible reason for these observations could be the complexity in the instructions associated with the scale. Further work on eliminating redundancies and improving the measurement properties is recommended.

Published
2018
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3. Training healthcare professionals to be ready for practice in an era of social distancing: A realist evaluation

Author

Janet Lefroy, Jessica Bialan, Alice Moult, Fiona Hay, Claire Stapleton, Jessica Thompson, Kate Diggory, Nageen Mustafa, Julia Farrington, Sarah A Aynsley, Simon Jacklin, Adam Winterton, and Natalie Cope

Abstract

Background Programme changes due to the COVID-19 pandemic have impacted variably on preparation for practice of healthcare professional students. Explanations for such variability in outcomes between institutions and healthcare professions have yet to be explored. The aim of our study was to understand what clinical learning, whilst under socially distanced restrictions, worked and why (or why not). Methods We conducted a realist evaluation of the undergraduate healthcare programmes at one UK university in 2020-21. The initial programme theories to be tested in this study were derived from discussions with programme leads about the changes they implemented due to the pandemic. Study participants were students and teaching faculty. Online interview transcripts were coded, identifying why the interventions in the programme had worked or not. This resulted in a set of ‘context-mechanism-outcome’ (CMO) statements about each intervention. The initial programme theories were refined as a result. Results and discussion 29 students and 22 faculty members participated. 18 CMO configurations were identified relating to clinical skills learning and 25 relating to clinical placements. Clinical skills learning was successful whether in person, remote or hybrid if it followed the steps of: demonstration – explanation – mental rehearsal – attempt with feedback. Where it didn’t work there was usually a lack of observation and corrective feedback. Placements were generally highly valued despite gaps in experience. Being useful on placements was felt to be good preparation for practice. Participant explanations from junior students about the value of various modes of induction to clinical workplace activity may also be relevant post-pandemic.

Published
2023
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4. Arterial Compression during Overhead Throwing: A Risk for Arterial Injury?

Author

N. Tim Cable, Keith George, Jade Elias, Daniel J. Green, and Claire Stapleton

Subjects
Adult, Male, medicine.medical_specialty, Acoustics and Ultrasonics, Biophysics, Vasodilation, Axillary artery, medicine.artery, Internal medicine, medicine, Humans, Radiology, Nuclear Medicine and imaging, Risk factor, Ultrasonography, Radiological and Ultrasound Technology, business.industry, Ultrasound, Surgery, body regions, medicine.anatomical_structure, Intima-media thickness, Athletic Injuries, Arm, cardiovascular system, Cardiology, Axillary Artery, Female, business, Throwing, Blood vessel, Artery
Abstract

Case studies reporting aneurysm formation in the axillary artery have been described in overhead throwing athletes, possibly due to repetitive arterial compression by the humeral head that has been transiently observed during sonographic diagnostic arm manoeuvres. Whether compression negatively alters arterial health has not been investigated and was the focus of this study. The throwing arm of elite overhead athletes was screened for inducible axillary artery compression. Compressors (COMP, n = 11, mean age: 20 (SD: 2) year, 7 male, 4 female) were age and sex matched with noncompressing (NONCOMP) athlete controls. Four indices of arterial health (flow mediated dilation [FMD], conduit artery vasodilatory capacity [CADC], glyceryl-trinitrate [GTN]-induced vasodilation and intima-media thickness [IMT]) were assessed with high-resolution ultrasound at the brachial and the axillary, artery. No significant between-group differences were observed at the brachial, or axillary, artery for FMD (brachial: COMP: mean (SD) 6.2 (3.1)%, NONCOMP: 6.1 (3.5)%, p = 0.967, axillary: COMP: 8.0 (5.5)%, NONCOMP: 9.0 (3.6)%, p = 0.602), CADC (brachial: COMP: 10.4 (3.4)%, NONCOMP: 10.4 (5.4)%, p = 0.999, axillary: COMP: 9.6 (4.2)%, NONCOMP: 8.5 (3.2)%, p = 0.492), GTN-induced vasodilation (brachial: COMP: 17.9 (5.1)%, NONCOMP:14.1 (7.2)%, p = 0.173, axillary: COMP: 9.5 (4.3)%, NONCOMP: 7.7 (3.1)%, p = 0.302) or IMT (brachial: p = 0.084, axillary: p = 0.581). These results suggest that transient arterial compression, observed during diagnostic arm manoeuvres in overhead throwing athletes, is not associated with abnormal indices of artery function or structure and that other mechanisms must be responsible for the published cases of aneurysm formation in elite athletes performing overhead throwing actions.

Published
2010
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5. Flow-Mediated Dilation and Intima-Media Thickness of the Brachial and Axillary Arteries in Individuals With and Without Inducible Axillary Artery Compression

Author

Claire Stapleton, Nigel Timothy Cable, Keith George, and Daniel J. Green

Subjects
Male, medicine.medical_specialty, Brachial Artery, Acoustics and Ultrasonics, Posture, Biophysics, Arterial Occlusive Diseases, Vasodilation, Doppler echocardiography, Young Adult, Axillary artery, medicine.artery, Internal medicine, Humans, Medicine, Radiology, Nuclear Medicine and imaging, Brachial artery, Reactive hyperemia, Radiological and Ultrasound Technology, medicine.diagnostic_test, business.industry, Ultrasonography, Doppler, Blood flow, Intima-media thickness, Athletes, Anesthesia, Cuff, cardiovascular system, Cardiology, Axillary Artery, Female, Tunica Intima, Tunica Media, business, Blood Flow Velocity
Abstract

The presence of axillary artery aneurysm and/or thrombus in overhead throwing athletes has been linked, theoretically, with the finding of compression by the humeral head induced by a diagnostic arm maneuver. However, whether this intermittent compression is incidental or of pathological significance has yet to be determined. Flow-mediated vasodilation (FMD), intima-media thickness (IMT) and maximum vasodilatory capacity were measured locally (3rd portion of the axillary artery) and downstream (brachial artery) in individuals previously tested for inducible axillary artery compression (compressor group [COMP]: n = 8, mean (SD) age: 23 (4) y; “noncompressor” control group [NONCOMP]: n = 8, 26 (4) y). A high-resolution ultrasound machine recorded arterial diameter and blood flow velocity. A rapid inflation/deflation pneumatic cuff placed distal to the site of measurement induced reactive hyperemia. Custom-designed wall tracking software with synchronized Doppler waveform analysis detected changes in arterial diameter, blood flow velocity and shear rate from baseline to 3 min after cuff deflation. Glyceryl trinitrate and/or ischemic hand grip exercises were administered to induce maximum vasodilation. No significant differences in FMD, IMT or maximum vasodilator capacity were observed between groups at the axillary artery. However, the downstream brachial FMD response was significantly diminished in the COMP group (6.38 [3.28]%) compared with the NONCOMP group (10.38 [2.74]%; p = 0.006) despite a comparable shear rate between groups (COMP: 81.92 (44.55) s −1 ; NONCOMP: 83.18 (40.02) s −1 ; p = 0.961). Pooled data revealed a significant negative relationship (r = −0.52, p = 0.038) between the FMD response and degree of arterial compression. These results suggest a chronic change in downstream vascular function in individuals demonstrating clinically significant inducible axillary artery compression. (E-mail: c.stapleton@2005.ljmu.ac.uk )

Published
2009
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6. Feasibility study of a take-home array-based functional electrical stimulation system with automated setup for current functional electrical stimulation users with foot-drop

Author

Mark L. Reeves, Sarah Prenton, Tracey Williamson, Laurence Kenney, David Howard, Tim Good, Ben Heller, Sibylle B. Thies, Glen Cooper, Jamie Healey, Claire Stapleton, Mohammad Sobuh, and Anthony T. Barker

Subjects
Adult, Male, RM, Foot drop, medicine.medical_specialty, Time Factors, Computer science, Electrical stimulator, Monitoring, Ambulatory, Physical Therapy, Sports Therapy and Rehabilitation, Electric Stimulation Therapy, Walking, Physical medicine and rehabilitation, Gait (human), Assistive technology, medicine, Functional electrical stimulation, Humans, Electrodes, Gait, Gait Disorders, Neurologic, Aged, Rehabilitation, Outcome measures, health_and_wellbeing, Swing, Middle Aged, R1, Preferred walking speed, Self Care, Patient Satisfaction, Feasibility Studies, Equipment Failure, Female, medicine.symptom, Ankle Joint
Abstract

Objective\ud \ud To investigate the feasibility of unsupervised community use of an array-based automated setup functional electrical stimulator for current foot-drop functional electrical stimulation (FES) users.\ud \ud Design\ud \ud Feasibility study.\ud \ud Setting\ud \ud Gait laboratory and community use.\ud \ud Participants\ud \ud Participants (N=7) with diagnosis of unilateral foot-drop of central neurologic origin (>6mo) who were regular users of a foot-drop FES system (>3mo).\ud \ud Intervention\ud \ud Array-based automated setup FES system for foot-drop (ShefStim).\ud \ud Main Outcome Measures\ud \ud Logged usage, logged automated setup times for the array-based automated setup FES system and diary recording of problems experienced, all collected in the community environment. Walking speed, ankle angles at initial contact, foot clearance during swing, and the Quebec User Evaluation of Satisfaction with Assistive Technology version 2.0 (QUEST version 2.0) questionnaire, all collected in the gait laboratory.\ud \ud Results\ud \ud All participants were able to use the array-based automated setup FES system. Total setup time took longer than participants' own FES systems, and automated setup time was longer than in a previous study of a similar system. Some problems were experienced, but overall, participants were as satisfied with this system as their own FES system. The increase in walking speed (N=7) relative to no stimulation was comparable between both systems, and appropriate ankle angles at initial contact (N=7) and foot clearance during swing (n=5) were greater with the array-based automated setup FES system.\ud \ud Conclusions\ud \ud This study demonstrates that an array-based automated setup FES system for foot-drop can be successfully used unsupervised. Despite setup's taking longer and some problems, users are satisfied with the system and it would appear as effective, if not better, at addressing the foot-drop impairment. Further product development of this unique system, followed by a larger-scale and longer-term study, is required before firm conclusions about its efficacy can be reached.

Published
2014

7. Clinical identification of cervical artery dissection

Author

Claire Stapleton and S. Chatting

Subjects
medicine.medical_specialty, business.industry, Cervical Artery, medicine, Physical Therapy, Sports Therapy and Rehabilitation, Identification (biology), Radiology, Dissection (medical), business, medicine.disease
Published
2016
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9. Sonographic evaluation of the axillary artery during simulated overhead throwing arm positions

Author

Lee Herrington, Keith George, and Claire Stapleton

Subjects
Adult, Male, medicine.medical_specialty, RM, Movement, Physical Therapy, Sports Therapy and Rehabilitation, Physical examination, Observation, Asymptomatic, Young Adult, Axillary artery, medicine.artery, Task Performance and Analysis, Medicine, Humans, Orthopedics and Sports Medicine, Ultrasonography, medicine.diagnostic_test, business.industry, Repeated measures design, health_and_wellbeing, General Medicine, Biomechanical Phenomena, Overhead throwing, medicine.anatomical_structure, Physical therapy, Arm, Upper limb, Axillary Artery, Observational study, Female, medicine.symptom, business, Blood Flow Velocity, Artery, Sports
Abstract

Objectives: The aim of this study was to determine changes in axillary artery diameter and peak systolic velocity in asymptomatic individuals during upper limb positioning commonly used to assess vascular pathology in athletes.\ud Design: Repeated measures observational study.\ud Setting: Physiology laboratory.\ud Participants: Subjective and objective screening excluded individuals with past, or present, conditions related to neurovascular compression syndromes. Thirty-one subjects (21 females, 10 males; mean age: 25±4 years) were included in the final analysis.\ud Main outcome measures: Sonographically determined axillary artery diameter and peak systolic velocity, as well as symptom production, were recorded for a series of 12 randomised arm positions, incorporating varying degrees of abduction, external rotation, and horizontal flexion/extension.\ud Results: The majority of arm positions revealed no change in artery diameter and peak systolic velocity. However, at the extreme of abduction, and arm positions incorporating 120° abduction, significant (p

Published
2008

10. Anterior translation at the glenohumeral joint: a cause of axillary artery compression?

Author

Keith George, Claire Stapleton, and Lee Herrington

Subjects
Adult, Joint Instability, Male, medicine.medical_specialty, Physical Therapy, Sports Therapy and Rehabilitation, Axillary artery, medicine.artery, medicine, Humans, Orthopedics and Sports Medicine, Overhead athletes, business.industry, Vascular disease, Shoulder Joint, Ultrasound, Blood flow, Compression (physics), medicine.disease, Surgery, medicine.anatomical_structure, External rotation, Axillary Artery, Female, business, Blood Flow Velocity, Blood vessel
Abstract

BackgroundLesions to the axillary artery are reported in overhead athletes. One speculated cause is repeated transient compression by the humeral head due to excessive laxity at the glenohumeral joint.Hypotheses(1) Anterior translation of the glenohumeral joint alters axillary artery diameter and blood flow characteristics, and (2) individuals demonstrating inducible axillary artery compression with the arm in an overhead position (as indicated by diameter and blood flow characteristics) will demonstrate greater magnitudes of anterior translation.Study DesignDescriptive laboratory study.MethodsAfter receiving ethical approval and screening for problematic conditions/injuries, 26 subjects were tested (10 men and 16 women; mean age [standard deviation], 25 years [4]). Axillary artery diameter and peak systolic velocity were measured with B-mode and Doppler ultrasound before, during, and after glenohumeral anterior translation at 90° of abduction, 60° of external rotation, and 30° of horizontal flexion, and at baseline and a simulated overhead throwing position (120° of abduction, 90° of external rotation, and 30° of horizontal extension). The magnitude of anterior translation was captured with B-mode ultrasound using a posterior transverse approach.ResultsApplication of the glide resulted in a significant (F2,21= 9.965, P = .001) reduction in axillary artery diameter and a significant increase in peak systolic velocity (F2,21= 5.286, P = .014). Subjects demonstrating clinically significant levels of axillary artery compression (>50% reduction in vessel diameter with the arm in the overhead throwing position) exhibited significantly (t = −2.260, P = .040) greater ranges of anterior translation at the glenohumeral joint than the 9 subjects who exhibited ConclusionsThis investigation provides the first empirical support for the clinical opinion that glenohumeral anterior translation could be a mechanism for inducible axillary artery compression.Clinical RelevanceThe response of axillary artery hemodynamics in normal, healthy individuals is the first step in the process of determining whether the finding of inducible axillary artery compression in overhead athletes with arterial pathology is related to glenohumeral translation.

Published
2007

11. Sonographic evaluation of the subclavian artery during thoracic outlet syndrome shoulder manoeuvres

Author

Claire Stapleton, Lee Herrington, and Keith George

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Health Status, Subclavian Artery, Physical Therapy, Sports Therapy and Rehabilitation, Asymptomatic, Risk Assessment, Cohort Studies, symbols.namesake, Young Adult, Reference Values, medicine.artery, Internal medicine, medicine, Humans, Range of Motion, Articular, Ultrasonography, Doppler, Color, Subclavian artery, Thoracic outlet syndrome, Probability, Analysis of Variance, business.industry, Shoulder Joint, General Medicine, Blood flow, medicine.disease, Surgery, Thoracic Outlet Syndrome, Bonferroni correction, Multiple comparisons problem, symbols, Cardiology, Female, Analysis of variance, medicine.symptom, Range of motion, business, Blood Flow Velocity
Abstract

Clinical tests for vascular thoracic outlet syndrome (vTOS) generally incorporate shoulder horizontal flexion/extension (HF/HE), abduction (ABD) and external rotation (ER). The effect of these clinical tests on blood flow characteristics and the most effective arm positions for detecting arterial compromise are, however, unknown. The aims of this study are to establish normative vascular responses in the subclavian artery (i.e. arterial diameter [D] and peak systolic blood flow velocity [PSV]) to various arm positions, and determine the incidence of abnormal physiological responses. Ten male and twenty-one female (mean age: 25 yr) healthy volunteers were rigorously screened prior to testing. With the subject seated the arm was passively supported in a randomised series of 12 standardised shoulder positions incorporating varying degrees of HF/HE, ABD and ER. Doppler ultrasound insonated the subclavian artery D (mm) and PSV (cms(-1)) in each position. Data comparisons were made using ANOVAs with bonferroni adjustment for multiple comparisons. Alpha level was set at p=0.01. Significant decreases (p=0.008) in PSV were recorded from 120 degrees , 90 degrees and 45 degrees ABD (92+/-10, 89+/-11 and 88+/-14 cm s(-1), respectively) to 180 degrees ABD (mean+/-95% CI: 52+/-16 cm s(-1)). Similarly, post-hoc comparisons revealed a significant decrease (p=0.008) in PSV from 120 degrees ABD (94+/-14 cm s(-1)) to 120 degrees ABD with 30 degrees HE and 90 degrees ER (69+/-12 cm s(-1)). Complete lack of blood flow was demonstrated by six subjects and two subjects at end of range ABD and combined end of range ER and HE, respectively. The heterogenous response of asymptomatic individuals with no past history of TOS symptoms raises uncertainty of the validity of positive test responses from extreme arm positions. Clinical decisions based on false positive outcomes have serious implications for mistreatment such as inappropriate surgical intervention; therefore it is imperative that clinical decision is not based on test outcomes alone. Further research is required to determine the cause of heterogenous responses in asymptomatics and discover means to improve test specificity.

Published
2006

13. Postoperative continuous positive airway pressure to prevent pneumonia, re-intubation, and death after major abdominal surgery (PRISM): a multicentre, open-label, randomised, phase 3 trial

Author

Rupert Pearse, Marco Ranieri, Tom Abbott, Mari-Liis Pakats, Edoardo Piervincenzi, Akshaykumar Patel, Brennan Kahan, Andrew Rhodes, Priyanthi Dias, Russell Hewson, Ib Jammer, Michelle Chew, Cesar Aldecoa, Reitze Rodseth, Bruce Biccard, Tim Stephens, Sara Payne, David Hepworth, Soeren Pischke, Joerund Asvall, John Hausken, Shaman Jhanji, Martin Rooms, Neil Flint, Dawn Hales, Tamas Szakmany, Andrew Leitch, Savino Spadaro, Davide Chiumello, Paul Johnston, Joyce Yeung, Guglielmo Tellan, Tonny Veenith, Josep Macmillan, Pierpaolo Terragni, Caroline Sander, Vidya Kasipandian, Tahania Ahmad, Aaron Lee, Marcello Tammaro, Danny McAuley, Simon Skene, Ravinder Vohra, Matt Wilson, Mark Edwards, Ewen Griffiths, Naomi Pritchard, Claudia Filippini, Tor Aasmundstad, Einar Aksnes, Lise-Merete Alpers, Andreas Barratt-Due, Anita Dahl, Linda Feldt, Elisa Figari, Eva Flåten, Karen Granheim, Minna Hagring, Håkon Haugaa, Gisle Kjoesen, Inge Klaevahaugen, Harald Lenz, Marianne Myhre, Hilde Orrem, Emily Stitt, Tor Inge Toennessen, Samuel Al-Kadhimi, Robert Anker, Mihaela Balint, Lauren Barraclough, Ethel Black, Matt Clayton, Leonora Conneely, Zara Edwards, Alex Eeles, Matthew Evans, Michelle Gerstman, Nicole Greenshields, Eleanor Harvey, Aoife Hegarty, Natalie Hester, Jenna Hutchinson, Ramanathan Kasivisvanathan, Helen Lawrence, Veronica Marsh, Laura Matthews, Francesca Mazzola, Jamie McCanny, Ben Morrison, Michelle O'Mahony, Ching Ling Pang, David Parkinson, Katrina Pirie, Ravishankar Rao Baikady, Louisa Shovel, Lorna Smith, Kate Tatham, Peter Thomas, Sophie Uren, Susanna Walker, Alasdair Wills, Prematie Andreou, Alex Howson, Jasmin Kaur, Adam Lewszuk, Esther Molina, Nirmalabaye Ramsamy, Emma Roberts, Vanessa Amaral, Salma Begum, Soliana Bekele, Richard Cashmore, Carmen Correia, Steven Dunkley, Maria Fernandez, Alexander Fowler, Amaia Garcia, Maria Della Giovampaola, Kathryn Greaves, Bethan Griffiths, Ryan Haines, Richard Haslop, Ying Hu, Sarah Hui, Marta Januszewska, Vasi Manon, Tim Martin, Shaun May, Annamaria Minicozzi, Edyta Niebrzegowska, Monica Oliveira, Katherine Pates, Filipa Santos, Tasnin Shahid, Paolo Simili, Alastair Somerville, Emily Subhedar, Ruzena Uddin, Sophie Walker, Yize Wan, Jan Whalley, Parjam Zolfaghari, Una Gunter, Gemma Hodkinson, Gwenllian Howe, Valentina Baratozzi, Giulia Casotto, Giulia Darai, Erica Ferrari, Giovanni Mistraletti, Valentina Palmaverdi, Stefano Furlani, Paolo Priani, Riccardo Ragazzi, Marco Salmaso, Marco Verri, Carlo Volta, Chris Nutt, Emma McKay, Orla O'Neill, Jaimin Patel, Katie Atterbury, Sarah Ballinger, Natalie Carling, Kaytie Ellis, Jo Gresty, Teresa Melody, Jade Monk, Chloe Norman, Eleanor Reeves, Julia Sampson, Peter Sutton, Marie Thomas, Amy Bamford, Colin Bergin, Ronald Carrera, Lauren Cooper, Liesl Despy, Karen Ellis, Emma Fellows, Stephanie Goundry, Samantha Harkett, Peter Ip, Tracy Mason, Christopher McGhee, Aisling McLaughlin, Aoife Neal, Martin Pope, Stephanie Porter, Hazel Smith, Catherine Snelson, Elaine Spruce, Ylenia Vigo, Arlo Whitehouse, Tony Whitehouse, Maria Donatiello, Sergio Gazzanelli, Mario Mezzapesa, Martina Savino, Giacomo Settesoldi, Gudrun Kunst, Sian Birch, Louise Greig, Harriet Noble, Evita Pappa, Bethany Penhaligon, Andrea Cossu, Leda Floris, Davide Piredda, Alberto Racca, Olof Brattstrom, Bente Heggelund, Magnus Flodberg, Sandra Månsson, Mamoona Ahmed, Jonathan Allen, Paula Bell, Roman Genetu, Julia Glennon, Janice Hanley, Katy Jenner, Summayyah Jogi, Parisa Mahjoob, Clare McGovern, Anthony Murphy, Roonak Nazari, Jacki Routledge, Trishna Uttamlal, Sinead Ward, Giorgio Iotti, Raffaella Picchioni, Silvia Poma, Paolo Navalesi, Andrea Bruni, Brunella De Leonardis, Eugenio Garofalo, Panna Patel, Carol McArthur, Karen Burns, Steven Peters, Giuseppe Foti, Serena Calcinati, Alice Grassi, Silvia Villa, John Berridge, Muthuraj Kanakaraj, Hazel Cahill, Greg Forshaw, Andy Gibson, Lia Grainger, Kate Howard, Katherine James, Zoe Murphy, Helen Sweeting, Rebecca Tait, Danielle Wilcock, David Yates, Sean Cope, Ashley Allan, Rebecca Betts, Sarah Cornell, Julie Sheriff, Lindsey Woods, Giacomo Grasselli, Matteo Brioni, Luigi Castagna, Richard von Rahden, Zane Farina, Samantha Green, Simphiwe Gumede, Chantal Rajah, Arisha Ramkillawan, Susan Moug, David Alcorn, Carol Dalton, Natalie Dickinson, Jennifer Edwards, Steven Henderson, Erin McIlveen, Richard Ramsaran, Joanne Bell, Lorna Fleming, Kathleen Monks, Jane Parker, Sean Stamper, Jo Stokes-Denson, Elisa Elías, Yessica Guerra, Jesus Rico-Feijoo, Carlos Kidel, Helder Filipe, Gretchelle Asis, Yvonne Gleeson, Alice Harvey, Christine Jackson, Margaret McNeil, Sara Mingo, Glykeria Pakou, Manuel Pinto, Stephen Wright, Maite Babio-Galan, David Buckley, Verity Calder, Ahmad Chishti, Joseph Cosgrove, Katherine Cullen, Leigh Dunn, Matthew Faulds, Jonathan Fortune, Matthew Gardner, Abigail Harrison, Carole Hays, Gerry Jones, Caroline Macfie, Iain Mccullagh, Ian Nesbitt, Suzanne O'Neil, Catherine Phoenix, Girish Rangaswamy, Craig Samson, Carmen Scott, Tara Shrestha, Rita Singh, Graham Soulsby, Jon Walton, Kimberley Zwiggelaar, Ceri Lynch, Heidi Clarke, Bethan Deacon, Helen Ivatt, Leanne Jones, Ahmed Latif, Shaun Oram, Chris Perman, Lisa Roche, Rowan Duys, Margot Flint, Kamal Bhagwan, Ettienne Coetzee, Ivan Joubert, Felipe Montoya-Pelaez, Pradeep Navsaria, Guy Picken, Owen Porrill, Grant Strathie, Thembinkosi Zungu, Sireesha Aluri, Simon Chau, Deborah Cooper, Mishell Cunningham, Allison Daniels, Susan Hope, Alice Nicholson, Laura Walker, Antonino Giarratano, Giuseppe Accurso, Santi Raineri, Giuseppe Tricoli, Richard Innes, Patricia Doble, Joanne Hutter, Corinne Pawley, Moira Tait, Mark Hamilton, Edward Andrade, Veronica Barnes, Claire Dalton, Carlos Delgado, Sarah Farnell-Ward, Helen Farrah, Geraldine Gray, Luisa Howlett, Gipsy Joseph, Monika Krupa, Susannah Leaver, Joao Macedo, Karen Maher, Johannes Mellinghoff, Rachel Oguntimehin, Joel Pereira, Frances Robinson, Christine Ryan, Nirav Shah, Paula Shirley, Alexandra Torborg, Thuli Biyase, Leanne Drummond, Belinda Kusel, Mbalenhle Mbuyisa, Sivuyisiwe Solala, Jenna Taylor, Adanma Ezihe-Ejiofor, Maame Aduse-Poku, Gary Colville, Louise Davies, Soo Kang, Alex Phillips, Justin Kirk-Bayley, Leigh Kelliher, Paula Carvelli, Gokce Daysal, Matthew Dickinson, Nancileigh Doyle, Christina Hughes, Laura Montague, Elizabeth Potter, Armorel Salberg, Sheena Sibug, Sinduja Sivarajan, Milo Thomson, Nichola Wakeford, Monica Rocco, Daniela Alampi, Daniel Conway, Richard Clark, Jashmin Maria, Fiona Pomeroy, Tanviha Quraishi, Abigail Williams, Srikanth Chukkambotla, Caroline Aherne, Donna Harrison-Briggs, Jill Fitchett, Stephen Duberley, Andrea Zanoni, Daniela Cardinale, Claudia Righi, Mark Blunt, Tracy Fuller, Ruth Hodgson, Melissa Rosbergen, Andrew Brennan, Louise Akeroyd, Victoria Boardman, Christopher Bull, Mike Carrick, Ian Chadderton, Sarah Cooper, Sarah Goellner, Laura Graham, Carl Ilyas, James King, Muhammad Laklouk, Tom Lawton, Christopher Macrow, Michael Munro, Adam Neep, Martin Northey, Victoria Peacock, Kate Pye, Lydia Radley, James Sira, Beth Smithson, Stuart Syddall, David Tooth, Thomas White, Sindre Hoel, Elin Aakre, Monica Bakke, Tone Hoivik, Arystarch Makowski, Harry Alcock, Sean Cardoso, Samantha Coetzee, Mary Everett, Mohamed Ibrahim, Christina Kouridaki, Vongayi Ogbeide, Elisabetta Bertellini, Valentina Bertolotti, Antonio Buono, Maria Fanigliulo, Ram Kumar, Nicole Richards, Alisha Allana, Samantha Bacciarelli, Helen Barker, Jessica De Bois, Isabel Bradley, Jennifer Crooks, Peter Daum, Alex Feben, Lizzie Gannon, Sarah Kipling, Andrew Peetamsingh, Charlotte Quamina, Sahiba Sethi, Harry Sivadhas, Kathryn Sollesta, Andrew Swain, Evalyn Tan, Joan Willis, Maggie Zou, Julius Cranshaw, Nina Barratt, Katie Bowman, Debbie Branney, Maria Letts, Sally Pitts, Christopher Day, Sarah Benyon, Sara Eddy, Adam Green, Anna Grice, Sinéad Kelly, Daisy Mackle, Victor Mariano, Linda Park, Pauline Sibley, William Spencer, Elena Bignami, Valentina Bellini, Francesco Forfori, Maria Curci, Alessandra Leo, Matthew Jackson, Jennifer Awolesi, Sheila Hodgkinson, Alissa Kent, Dee Leonard, Claire Stapleton, Clare Tibke, Farhad Alexander-Sefre, Lorraine Campey, Kathryn Hall, Jennifer Spimpolo, Malin Nilsson, Helen Didriksson, Emma Hamilton, Mandy Carnahan, Chris Mowatt, Jo Stickley, Antonio Corcione, Giuseppe Rossi, Hege Fladby, Nina Andersen, Gunhild Bjoernå, Mads Reite, Linda Roertveit, Philipp Seidel, Glenn Arnold, Melissa Benavente, Anjalee Chattersingh, Nyasha Chironga, Gillian Hornzee, Joyce Kibaru, Ihtisham Malik, Laura McLeavy, Byiravey Pathmanathan, Florence Prior, Rhea Strudwick, Marios Vezyrgiannis, Aneeta Sinha, Sheeba Babu, Bisanth Batuwitage, Zoe Daly, Katharine Ellinor, Elizabeth Hawes, Ann Holmes, Karen Hudson, Jeremy Nightingale, Alison Le Poidevin, Lindsey Roberts, Agnieszka Kubisz-Pudelko, Joanna Allison, Lucy Pippard, Vincent Hamlyn, Angie Organ, Thaventhran Prabhahar, Hayley Bridger, Lee Dvorkin, Vitul 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Subjects
Pulmonary and Respiratory Medicine, medicine.medical_treatment, Population, NO, 03 medical and health sciences, 0302 clinical medicine, CPAP, Abdomen, Settore MED/41 - ANESTESIOLOGIA, Intubation, Intratracheal, medicine, Humans, Intubation, 030212 general & internal medicine, Continuous positive airway pressure, Adverse effect, education, education.field_of_study, Continuous Positive Airway Pressure, business.industry, respiratory complications, continuous positive airway pressure, major abdominal surgery, Pneumonia, Middle Aged, medicine.disease, respiratory tract diseases, Intratracheal, Treatment Outcome, 030228 respiratory system, Respiratory failure, Anesthesia, Vomiting, medicine.symptom, Respiratory Insufficiency, business, Abdominal surgery
Abstract

BackgroundRespiratory complications are an important cause of postoperative morbidity. We aimed to investigate whether continuous positive airway pressure (CPAP) administered immediately after major abdominal surgery could prevent postoperative morbidity.MethodsPRISM was an open-label, randomised, phase 3 trial done at 70 hospitals across six countries. Patients aged 50 years or older who were undergoing elective major open abdominal surgery were randomly assigned (1:1) to receive CPAP within 4 h of the end of surgery or usual postoperative care. Patients were randomly assigned using a computer-generated minimisation algorithm with inbuilt concealment. The primary outcome was a composite of pneumonia, endotracheal re-intubation, or death within 30 days after randomisation, assessed in the intention-to-treat population. Safety was assessed in all patients who received CPAP. The trial is registered with the ISRCTN registry, ISRCTN56012545.FindingsBetween Feb 8, 2016, and Nov 11, 2019, 4806 patients were randomly assigned (2405 to the CPAP group and 2401 to the usual care group), of whom 4793 were included in the primary analysis (2396 in the CPAP group and 2397 in the usual care group). 195 (8·1%) of 2396 patients in the CPAP group and 197 (8·2%) of 2397 patients in the usual care group met the composite primary outcome (adjusted odds ratio 1·01 [95% CI 0·81-1·24]; p=0·95). 200 (8·9%) of 2241 patients in the CPAP group had adverse events. The most common adverse events were claustrophobia (78 [3·5%] of 2241 patients), oronasal dryness (43 [1·9%]), excessive air leak (36 [1·6%]), vomiting (26 [1·2%]), and pain (24 [1·1%]). There were two serious adverse events: one patient had significant hearing loss and one patient had obstruction of their venous catheter caused by a CPAP hood, which resulted in transient haemodynamic instability.InterpretationIn this large clinical effectiveness trial, CPAP did not reduce the incidence of pneumonia, endotracheal re-intubation, or death after major abdominal surgery. Although CPAP has an important role in the treatment of respiratory failure after surgery, routine use of prophylactic post-operative CPAP is not recommended.FundingNational Institute for Health Research, Barts Charity, Intersurgical, Association of Anaesthetists, and Sapienza Università di Roma.

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