116 results on '"Gilfoyle, Elaine"'
Search Results
102. Additional file 1: of Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial
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OâHearn, Katharine, Dayre McNally, Choong, Karen, Acharya, Anand, Wong, Hector, Lawson, Margaret, Ramsay, Tim, Lauralyn McIntyre, Gilfoyle, Elaine, Tucci, Marisa, Wensley, David, Gottesman, Ronald, Morrison, Gavin, and Menon, Kusum
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3. Good health - Abstract
SPIRIT Checklist. (DOC 143 kb)
103. Additional file 1: of Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial
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OâHearn, Katharine, Dayre McNally, Choong, Karen, Acharya, Anand, Wong, Hector, Lawson, Margaret, Ramsay, Tim, Lauralyn McIntyre, Gilfoyle, Elaine, Tucci, Marisa, Wensley, David, Gottesman, Ronald, Morrison, Gavin, and Menon, Kusum
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3. Good health - Abstract
SPIRIT Checklist. (DOC 143 kb)
104. Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial
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O’Hearn, Katharine, McNally, Dayre, Choong, Karen, Acharya, Anand, Wong, Hector R, Lawson, Margaret, Ramsay, Tim, McIntyre, Lauralyn, Gilfoyle, Elaine, Tucci, Marisa, Wensley, David, Gottesman, Ronald, Morrison, Gavin, and Menon, Kusum
- Subjects
3. Good health - Abstract
Background: Physicians often administer corticosteroids for the treatment of fluid and vasoactive infusion dependent pediatric shock. This use of corticosteroids is controversial, however, and has never been studied in a pediatric randomized controlled trial (RCT). This pilot trial will determine the feasibility of a larger RCT on the role of corticosteroids in pediatric shock. Methods/design: Steroids in Fluid and/or Vasoactive Infusion Dependent Pediatric Shock (STRIPES) is a pragmatic, seven-center, double-blind, pilot RCT. We aim to randomize 72 pediatric patients with fluid and vasoactive infusion dependent shock to receive either hydrocortisone or a saline placebo for 7 days or until clinical stability, whichever occurs first. The primary outcome of this pilot trial is the feasibility of recruitment, defined as the number of patients enrolled over a 1-year period. Secondary outcomes include the frequency of, and reasons for, open-label steroid use, protocol adherence, incidence of mortality and corticosteroid-associated adverse events, time to discontinuation of inotropes, and feasibility of blood sampling. Discussion: Corticosteroids are used for the treatment of pediatric shock without sufficient evidence to support this practice. While there is a scientific rationale and limited data supporting their use in this setting, there is also evidence from other populations suggesting potential harm. The STRIPES pilot study will assess the feasibility of a larger, much needed trial powered for clinically important outcomes. Trial registration: ClinicalTrials.gov: NCT02044159
105. 2019 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations: Summary From the Basic Life Support; Advanced Life Support; Pediatric Life Support; Neonatal Life Support; Education, Implementation, and Teams; and First Aid Task Forces
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Soar, Jasmeet, Maconochie, Ian, Wyckoff, Myra H, Olasveengen, Theresa M, Singletary, Eunice M, Greif, Robert, Aickin, Richard, Bhanji, Farhan, Donnino, Michael W, Mancini, Mary E, Wyllie, Jonathan P, Zideman, David, Andersen, Lars W, Atkins, Dianne L, Aziz, Khalid, Bendall, Jason, Berg, Katherine M, Berry, David C, Bigham, Blair L, Bingham, Robert, Couto, Thomaz Bittencourt, Böttiger, Bernd W, Borra, Vere, Bray, Janet E, Breckwoldt, Jan, Brooks, Steven C, Buick, Jason, Callaway, Clifton W, Carlson, Jestin N, Cassan, Pascal, Castrén, Maaret, Chang, Wei-Tien, Charlton, Nathan P, Cheng, Adam, Chung, Sung Phil, Considine, Julie, Couper, Keith, Dainty, Katie N, Dawson, Jennifer Anne, De Almeida, Maria Fernanda, De Caen, Allan R, Deakin, Charles D, Drennan, Ian R, Duff, Jonathan P, Epstein, Jonathan L, Escalante, Raffo, Gazmuri, Raúl J, Gilfoyle, Elaine, Granfeldt, Asger, Guerguerian, Anne-Marie, Guinsburg, Ruth, Hatanaka, Tetsuo, Holmberg, Mathias J, Hood, Natalie, Hosono, Shigeharu, Hsieh, Ming-Ju, Isayama, Tetsuya, Iwami, Taku, Jensen, Jan L, Kapadia, Vishal, Kim, Han-Suk, Kleinman, Monica E, Kudenchuk, Peter J, Lang, Eddy, Lavonas, Eric, Liley, Helen, Lim, Swee Han, Lockey, Andrew, Lofgren, Bo, Ma, Matthew Huei-Ming, Markenson, David, Meaney, Peter A, Meyran, Daniel, Mildenhall, Lindsay, Monsieurs, Koenraad G, Montgomery, William, Morley, Peter T, Morrison, Laurie J, Nadkarni, Vinay M, Nation, Kevin, Neumar, Robert W, Ng, Kee-Chong, Nicholson, Tonia, Nikolaou, Nikolaos, Nishiyama, Chika, Nuthall, Gabrielle, Ohshimo, Shinichiro, Okamoto, Deems, O'Neil, Brian, Yong-Kwang Ong, Gene, Paiva, Edison F, Parr, Michael, Pellegrino, Jeffrey L, Perkins, Gavin D, Perlman, Jeffrey, Rabi, Yacov, Reis, Amelia, Reynolds, Joshua C, Ristagno, Giuseppe, Roehr, Charles C, Sakamoto, Tetsuya, Sandroni, Claudio, Schexnayder, Stephen M, Scholefield, Barnaby R, Shimizu, Naoki, Skrifvars, Markus B, Smyth, Michael A, Stanton, David, Swain, Janel, Szyld, Edgardo, Tijssen, Janice, Travers, Andrew, Trevisanuto, Daniele, Vaillancourt, Christian, Van De Voorde, Patrick, Velaphi, Sithembiso, Wang, Tzong-Luen, Weiner, Gary, Welsford, Michelle, Woodin, Jeff A, Yeung, Joyce, Nolan, Jerry P, and Fran Hazinski, Mary
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health care facilities, manpower, and services ,education ,610 Medicine & health ,health care economics and organizations ,3. Good health - Abstract
The International Liaison Committee on Resuscitation has initiated a continuous review of new, peer-reviewed, published cardiopulmonary resuscitation science. This is the third annual summary of the International Liaison Committee on Resuscitation International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. It addresses the most recent published resuscitation evidence reviewed by International Liaison Committee on Resuscitation Task Force science experts. This summary addresses the role of cardiac arrest centers and dispatcher-assisted cardiopulmonary resuscitation, the role of extracorporeal cardiopulmonary resuscitation in adults and children, vasopressors in adults, advanced airway interventions in adults and children, targeted temperature management in children after cardiac arrest, initial oxygen concentration during resuscitation of newborns, and interventions for presyncope by first aid providers. Members from 6 International Liaison Committee on Resuscitation task forces have assessed, discussed, and debated the certainty of the evidence on the basis of the Grading of Recommendations, Assessment, Development, and Evaluation criteria, and their statements include consensus treatment recommendations. Insights into the deliberations of the task forces are provided in the Justification and Evidence to Decision Framework Highlights sections. The task forces also listed priority knowledge gaps for further research.
106. 2019 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations
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Soar, Jasmeet, Maconochie, Ian, Wyckoff, Myra H, Olasveengen, Theresa M, Singletary, Eunice M, Greif, Robert, Aickin, Richard, Bhanji, Farhan, Donnino, Michael W, Mancini, Mary E, Wyllie, Jonathan P, Zideman, David, Andersen, Lars W, Atkins, Dianne L, Aziz, Khalid, Bendall, Jason, Berg, Katherine M, Berry, David C, Bigham, Blair L, Bingham, Robert, Couto, Thomaz Bittencourt, Böttiger, Bernd W, Borra, Vere, Bray, Janet E, Breckwoldt, Jan, Brooks, Steven C, Buick, Jason, Callaway, Clifton W, Carlson, Jestin N, Cassan, Pascal, Castrén, Maaret, Chang, Wei-Tien, Charlton, Nathan P, Cheng, Adam, Chung, Sung Phil, Considine, Julie, Couper, Keith, Dainty, Katie N, Dawson, Jennifer Anne, De Almeida, Maria Fernanda, De Caen, Allan R, Deakin, Charles D, Drennan, Ian R, Duff, Jonathan P, Epstein, Jonathan L, Escalante, Raffo, Gazmuri, Raúl J, Gilfoyle, Elaine, Granfeldt, Asger, Guerguerian, Anne-Marie, Guinsburg, Ruth, Hatanaka, Tetsuo, Holmberg, Mathias J, Hood, Natalie, Hosono, Shigeharu, Hsieh, Ming-Ju, Isayama, Tetsuya, Iwami, Taku, Jensen, Jan L, Kapadia, Vishal, Kim, Han-Suk, Kleinman, Monica E, Kudenchuk, Peter J, Lang, Eddy, Lavonas, Eric, Liley, Helen, Lim, Swee Han, Lockey, Andrew, Lofgren, Bo, Ma, Matthew Huei-Ming, Markenson, David, Meaney, Peter A, Meyran, Daniel, Mildenhall, Lindsay, Monsieurs, Koenraad G, Montgomery, William, Morley, Peter T, Morrison, Laurie J, Nadkarni, Vinay M, Nation, Kevin, Neumar, Robert W, Ng, Kee-Chong, Nicholson, Tonia, Nikolaou, Nikolaos, Nishiyama, Chika, Nuthall, Gabrielle, Ohshimo, Shinichiro, Okamoto, Deems, O'Neil, Brian, Ong, Gene Yong-Kwang, Paiva, Edison F, Parr, Michael, Pellegrino, Jeffrey L, Perkins, Gavin D, Perlman, Jeffrey, Rabi, Yacov, Reis, Amelia, Reynolds, Joshua C, Ristagno, Giuseppe, Roehr, Charles C, Sakamoto, Tetsuya, Sandroni, Claudio, Schexnayder, Stephen M, Scholefield, Barnaby R, Shimizu, Naoki, Skrifvars, Markus B, Smyth, Michael A, Stanton, David, Swain, Janel, Szyld, Edgardo, Tijssen, Janice, Travers, Andrew, Trevisanuto, Daniele, Vaillancourt, Christian, Van De Voorde, Patrick, Velaphi, Sithembiso, Wang, Tzong-Luen, Weiner, Gary, Welsford, Michelle, Woodin, Jeff A, Yeung, Joyce, Nolan, Jerry P, and Hazinski, Mary Fran
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health care facilities, manpower, and services ,education ,610 Medicine & health ,health care economics and organizations ,3. Good health - Abstract
The International Liaison Committee on Resuscitation has initiated a continuous review of new, peer-reviewed, published cardiopulmonary resuscitation science. This is the third annual summary of the International Liaison Committee on Resuscitation International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. It addresses the most recent published resuscitation evidence reviewed by International Liaison Committee on Resuscitation Task Force science experts. This summary addresses the role of cardiac arrest centers and dispatcher-assisted cardiopulmonary resuscitation, the role of extracorporeal cardiopulmonary resuscitation in adults and children, vasopressors in adults, advanced airway interventions in adults and children, targeted temperature management in children after cardiac arrest, initial oxygen concentration during resuscitation of newborns, and interventions for presyncope by first aid providers. Members from 6 International Liaison Committee on Resuscitation task forces have assessed, discussed, and debated the certainty of the evidence on the basis of the Grading of Recommendations, Assessment, Development, and Evaluation criteria, and their statements include consensus treatment recommendations. Insights into the deliberations of the task forces are provided in the Justification and Evidence to Decision Framework Highlights sections. The task forces also listed priority knowledge gaps for further research.
107. Additional file 2: of Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial
- Author
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OâHearn, Katharine, Dayre McNally, Choong, Karen, Acharya, Anand, Wong, Hector, Lawson, Margaret, Ramsay, Tim, Lauralyn McIntyre, Gilfoyle, Elaine, Tucci, Marisa, Wensley, David, Gottesman, Ronald, Morrison, Gavin, and Menon, Kusum
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3. Good health - Abstract
Summary of mechanistic studies. This table summarizes the mechanistic studies that will be performed as part of the STRIPES pilot study, including the rationale, timing, and amount of blood sample required for each test. (PDF 202 kb)
108. The Effect of Hemoglobin Levels on Mortality in Pediatric Patients with Severe Traumatic Brain Injury
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F. Yee, Kevin, M. Walker, Andrew, and Gilfoyle, Elaine
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Objective. There is increasing evidence of adverse outcomes associated with blood transfusions for adult traumatic brain injury patients. However, current evidence suggests that pediatric traumatic brain injury patients may respond to blood transfusions differently on a vascular level. This study examined the influence of blood transfusions and anemia on the outcome of pediatric traumatic brain injury patients. Design. A retrospective cohort analysis of severe pediatric traumatic brain injury (TBI) patients was undertaken to investigate the association between blood transfusions and anemia on patient outcomes. Measurements and Main Results. One hundred and twenty patients with severe traumatic brain injury were identified and included in the analysis. The median Glasgow Coma Scale (GCS) was 6 and the mean hemoglobin (Hgb) on admission was 115.8 g/L. Forty-three percent of patients (43%) received at least one blood transfusion and the mean hemoglobin before transfusion was 80.1 g/L. Multivariable regression analysis revealed that anemia and the administration of packed red blood cells were not associated with adverse outcomes. Factors that were significantly associated with mortality were presence of abusive head trauma, increasing PRISM score, and low GCS after admission. Conclusion. In this single centre retrospective cohort study, there was no association found between anemia, blood transfusions, and hospital mortality in a pediatric traumatic brain injury patient population.
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- 2016
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109. How Industrial and Organizational Psychology can Impact Innovation in Health Care.
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O'Neill, Thomas, Gilfoyle, Elaine, Cheng, Adam, and Caird, Jeff
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INTERDISCIPLINARY research , *PSYCHOLOGY - Abstract
The article offers information on the interdisciplinary research program at the University of Calgary in Alberta on hospital pediatric resuscitation teams using industrial and organizational (I-O) psychology best practices.
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- 2012
110. Cognitive aids used in simulated resuscitation: A systematic review.
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Nabecker S, Nation K, Gilfoyle E, Abelairas-Gomez C, Koota E, Lin Y, and Greif R
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Objectives: To compare the effectiveness of cognitive aid use during resuscitation with no use of cognitive aids on cardiopulmonary resuscitation quality and performance., Methods: This systematic review followed the PICOST format. All randomised controlled trials and non-randomised studies evaluating cognitive aid use during (simulated) resuscitation were included in any setting. Unpublished studies were excluded. We did not include studies that reported cognitive aid use during training for resuscitation alone. Medline, Embase and Cochrane databases were searched from inception until July 2019 (updated August 2022, November 2023, and 23 April 2024). We did not search trial registries. Title and abstract screening, full-text screening, data extraction, risk of bias assessment (using RoB2 and ROBINS-I), and certainty of evidence (using GRADE) were performed by two researchers. PRISMA reporting standards were followed, and registration (PROSPERO CRD42020159162, version 19 July 2022) was performed. No funding has been obtained., Results: The literature search identified 5029 citations. After removing 512 duplicates, reviewing the titles and abstracts of the remaining articles yielded 103 articles for full-text review. Hand-searching identified 3 more studies for full-text review. Of these, 29 studies were included in the final analysis. No clinical studies involving patients were identified. The review was limited to indirect evidence from simulation studies only. The results are presented in five different populations: healthcare professionals managing simulated resuscitations in neonates, children, adult advanced life support, and other emergencies; as well as lay providers managing resuscitations. Main outcomes were adherence to protocol or process, adherence to protocol or process assessed by performance score, CPR performance and retention, and feasibility of chatbot guidance. The risk of bias assessment ranged from low to high. Studies in neonatal, paediatric and adult life support delivered by healthcare professionals showed benefits of using cognitive aids, however, some studies evaluating resuscitations by lay providers reported undesirable effects. The performance of a meta -analysis was not possible due to significant methodological heterogeneity. The certainty of evidence was rated as moderate to very low due to serious indirectness, (very) serious risk of bias, serious inconsistency and (very) serious imprecision., Conclusion: Because of the very low certainty evidence from simulation studies, we suggest that cognitive aids should be used by healthcare professionals during resuscitation. In contrast, we do not suggest use of cognitive aids for lay providers, based on low certainty evidence., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: SN, KN, CAG, EK, and RG are members of the ILCOR EIT Task Force (RG is chair). RG is ERC Director of Guidelines and ILCOR, RG is Editorial Board member of Resuscitation Plus., (© 2024 The Author(s).)
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- 2024
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111. Video Review of Simulated Pediatric Cardiac Arrest to Identify Errors/Latent Safety Threats: A Mixed Methods Study.
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Garcia-Jorda D, Nikitovic D, and Gilfoyle E
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- Child, Humans, Communication, Alberta, Resuscitation methods, Heart Arrest therapy
- Abstract
Introduction: Outcomes from pediatric in-hospital cardiac arrest depend on the treatment provided as well as resuscitation team performance. Our study aimed to identify errors occurring in this clinical context and develop an analytical framework to classify them. This analytical framework provided a better understanding of team performance, leading to improved patient outcomes., Methods: We analyzed 25 video recordings of pediatric cardiac arrest simulations from the pediatric intensive care unit at the Alberta Children's Hospital. We conducted a qualitative-dominant crossover mixed method analysis to produce a broad understanding of the etiology of errors. Using qualitative framework analysis, we identified and qualitatively described errors and transformed the data coded into quantitative data to determine the frequency of errors., Results: We identified 546 errors/error-related actions and behaviors and 25 near misses. The errors were coded into 21 codes that were organized into 5 main themes. Clinical task-related errors accounted for most errors (41.9%), followed by planning, and executing task-related errors (22.3%), distraction-related errors (18.7%), communication-related errors (10.1%), and knowledge/training-related errors (7%)., Conclusions: This novel analytical framework can robustly identify, classify, and describe the root causes of errors within this complex clinical context. Future validation of this classification of errors and error-related actions and behaviors on larger samples of resuscitations from various contexts will allow for a better understanding of how errors can be mitigated to improve patient outcomes., Competing Interests: The authors declare no conflict of interest., (Copyright © 2022 Society for Simulation in Healthcare.)
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- 2023
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112. Case report: Foreign body aspiration requiring extracorporeal membrane oxygenation.
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Ginter D, Johnson KT, Venettacci O, Vanderlaan RD, Gilfoyle E, and Mtaweh H
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Introduction: Foreign body aspiration is a common cause of respiratory distress in pediatrics, but the diagnosis can be challenging given aspirated objects are mostly radiolucent on chest radiographs and there is often no witnessed choking event. We present a case of a patient who was initially managed as severe status asthmaticus, requiring veno-arterial extracorporeal membrane oxygenation (VA-ECMO) for refractory hypercarbia and hypoxemia, but was later found to have bilateral bronchial foreign body aspiration. This case is unique in its severity of illness, diagnostic dilemma with findings suggesting a more common diagnosis of asthma, and use of ECMO as a bridge to diagnosis and recovery., Patient Case: A previously healthy 2-year-old boy presented during peak viral season with a 3-day history of fever, cough, coryza, and increased work of breathing over the prior 24 h. There was no reported history of choking or aspiration. He was diagnosed with asthma and treated with bronchodilator therapy. Physical examination revealed pulsus paradoxus, severe work of breathing with bilateral wheeze, and at times a silent chest. Chest radiographs showed bilateral lung hyperinflation. Following a brief period of stability on maximum bronchodilator therapies and bilevel positive pressure support, the patient had a rapid deterioration requiring endotracheal intubation, with subsequent cannulation to VA-ECMO. A diagnostic flexible bronchoscopy was performed and demonstrated bilateral foreign bodies, peanuts, in the right bronchus intermedius and the left mainstem bronchus. Removal of the foreign bodies was done by rigid bronchoscopy facilitating rapid wean from VA-ECMO and decannulation within 24 h of foreign body removal., Conclusion: Foreign body aspiration should be suspected in all patients presenting with atypical history and physical examination findings, or in patients with suspected common diagnoses who do not progress as expected or deteriorate after a period of stability. Extracorporeal life support can be used as a bridge to diagnosis and recovery in patients with hemodynamic or respiratory instability., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Ginter, Johnson, Venettacci, Vanderlaan, Gilfoyle and Mtaweh.)
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- 2023
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113. The impact of clinical result acquisition and interpretation on task performance during a simulated pediatric cardiac arrest: a multicentre observational study.
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Rizkalla C, Garcia-Jorda D, Cheng A, Duff JP, Gottesman R, Weiss MJ, Koot DA, and Gilfoyle E
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- Child, Humans, Patient Care Team, Resuscitation education, Task Performance and Analysis, Cardiopulmonary Resuscitation methods, Heart Arrest therapy
- Abstract
Purpose: The acquisition and interpretation of clinical results during resuscitations is common; however, this can delay critical clinical tasks, resulting in increased morbidity and mortality. This study aims to determine the impact of clinical result acquisition and interpretation by the team leader on critical task completion during simulated pediatric cardiac arrest before and after team training., Methods: This is a secondary data analysis of video-recorded simulated resuscitation scenarios conducted during Teams4Kids (T4K) study (June 2011-January 2015); scenarios included cardiac arrest before and after team training. The scenario included either a scripted paper or a phone call delivery of results concurrently with a clinical transition to pulseless ventricular tachycardia. Descriptive statistics and non-parametric tests were used to compare team performance before and after training., Results: Performance from 40 teams was analyzed. Although the time taken to initiate CPR and defibrillation varied depending on the type of interruption and whether the scenario was before or after team training, these findings were not significantly associated with the leader's behaviour [Kruskal-Wallis test (p > 0.05)]. An exact McNemar's test determined no statistically significant difference in the proportion of leaders involved or not in interpreting results between and after the training (exact p value = 0.096)., Conclusions: Team training was successful in reducing time to perform key clinical tasks. Although team training modified the way leaders behaved toward the results, this behaviour change did not impact the time taken to start CPR or defibrillate. Further understanding the elements that influence time to critical clinical tasks provides guidance in designing future simulated educational activities, subsequently improving clinical team performance and patient outcomes., (© 2022. The Author(s).)
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- 2022
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114. A taxonomy and rating system to measure situation awareness in resuscitation teams.
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O'Neill TA, White J, Delaloye N, and Gilfoyle E
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- Canada, Humans, Patient Care Team, Simulation Training methods, Video Recording methods, Awareness physiology, Education methods, Resuscitation methods
- Abstract
Team SA involves a common perspective between two or more individuals regarding current environmental events, their meaning, and projected future status. Team SA has been theorized to be important for resuscitation team effectiveness. Accordingly, multidimensional frameworks of observable behaviors relevant to resuscitation teams are needed to understand more deeply the nature of team SA, its implications for team effectiveness, and whether it can be trained. A seven-dimension team resuscitation SA framework was developed following a literature review and consensus process using a modified Delphi approach with a group of content experts. We applied a pre-post design within a day-long team training program involving four video-recorded simulated resuscitation events and 42 teams across Canada. The first and fourth events represented "pre" and "post" training events, respectively. Teams were scored on SA five times within each 15-minute event. Distractions were introduced to investigate whether SA scores would be affected. The current study provides initial construct validity evidence for a new measure of SA and explicates SA's role in resuscitation teams.
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- 2018
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115. Erratum to: Pediatric intensive care stress ulcer prevention (PIC-UP): a protocol for a pilot randomized trial.
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Duffett M, Choong K, Foster J, Gilfoyle E, Lacroix J, Pai N, Thabane L, and Cook DJ
- Abstract
[This corrects the article DOI: 10.1186/s40814-017-0142-y.].
- Published
- 2017
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116. Pediatric intensive care stress ulcer prevention (PIC-UP): a protocol for a pilot randomized trial.
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Duffett M, Choong K, Foster J, Gilfoyle E, Lacroix J, Pai N, Thabane L, and Cook DJ
- Abstract
Background: Despite sparse pediatric data on effectiveness, the majority of critically ill children receive medications to prevent gastrointestinal (GI) bleeding. Stress ulcer prophylaxis may have unintended consequences-increasing the risk of nosocomial infections-which may be more serious and common than the bleeding which these drugs are prescribed to prevent. Randomized controlled trials (RCTs) in pediatric critical care are exceptionally challenging to complete, thus a rigorous pilot RCT is crucial. The objective of this pilot RCT is to assess the feasibility of a large multicentre RCT of stress ulcer prophylaxis with pantoprazole to prevent upper GI bleeding vs. placebo., Methods: A multi-centre blinded pilot RCT of 120 children in six Canadian PICUs. Children expected to require mechanical ventilation for more than 48 h will be randomized to receive intravenous pantoprazole 1 mg/kg or identical placebo once daily until they no longer need mechanical ventilation. We have four feasibility outcomes and will consider the trial successful if we achieve:Effective screening: If >80% of eligible patients are approached for consent.Timely enrollment: if >80% of participants receive their first dose of the assigned study drug within 1 day of becoming eligible.Participant accrual: If the average monthly enrolment is two or more participants per centre per month.Protocol adherence: if >90% of doses are administered according to the protocol., Discussion: There are many uncertainties about the risks and benefits of stress ulcer prophylaxis. In an era of widespread use-where clinicians prescribe prophylaxis to the more severely ill-a large, rigorous RCT is required. A trial to determine if a strategy of withholding stress ulcer prophylaxis is not inferior to a strategy of routine stress ulcer prophylaxis will be challenging. A carefully designed and implemented pilot trial is essential., Trial Registration: ClinicalTrials.gov:NCT02929563 (Registered October 3, 2016).
- Published
- 2017
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