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1. mSep: investigating physiological and immune-metabolic biomarkers in septic and healthy pregnant women to predict feto-maternal immune health – a prospective observational cohort study protocol

Author

Simran Sharma, Summia Zaher, Patrícia R S Rodrigues, Luke C Davies, Sarah Edkins, Angela Strang, Mallinath Chakraborty, W John Watkins, Robert Andrews, Edward Parkinson, Nicos Angelopoulos, Linda Moet, Freya Shepherd, Kate Megan Megan Davies, Daniel White, Shaun Oram, Kate Siddall, Vikki Keeping, Kathryn Simpson, Federica Faggian, Maryanne Bray, Claire Bertorelli, Sarah Bell, Rachel E Collis, James E McLaren, Mario Labeta, Valerie B O’Donnell, and Peter Ghazal

Subjects
Adult, Adolescent, Cesarean Section, Infant, Newborn, General Medicine, Anti-Bacterial Agents, Cohort Studies, Observational Studies as Topic, C-Reactive Protein, Pre-Eclampsia, Pregnancy, Sepsis, Lactates, Humans, Female, Pregnant Women, Prospective Studies, Pregnancy Complications, Infectious, Biomarkers
Abstract

IntroductionMaternal sepsis remains a leading cause of death in pregnancy. Physiological adaptations to pregnancy obscure early signs of sepsis and can result in delays in recognition and treatment. Identifying biomarkers that can reliably diagnose sepsis will reduce morbidity and mortality and antibiotic overuse. We have previously identified an immune-metabolic biomarker network comprising three pathways with a >99% accuracy for detecting bacterial neonatal sepsis. In this prospective study, we will describe physiological parameters and novel biomarkers in two cohorts—healthy pregnant women and pregnant women with suspected sepsis—with the aim of mapping pathophysiological drivers and evaluating predictive biomarkers for diagnosing maternal sepsis.Methods and analysisWomen aged over 18 with an ultrasound-confirmed pregnancy will be recruited to a pilot and two main study cohorts. The pilot will involve blood sample collection from 30 pregnant women undergoing an elective caesarean section. Cohort A will follow 100 healthy pregnant women throughout their pregnancy journey, with collection of blood samples from participants at routine time points in their pregnancy: week 12 ‘booking’, week 28 and during labour. Cohort B will follow 100 pregnant women who present with suspected sepsis in pregnancy or labour and will have at least two blood samples taken during their care pathway. Study blood samples will be collected during routine clinical blood sampling. Detailed medical history and physiological parameters at the time of blood sampling will be recorded, along with the results of routine biochemical tests, including C reactive protein, lactate and white blood cell count. In addition, study blood samples will be processed and analysed for transcriptomic, lipidomic and metabolomic analyses and both qualitative and functional immunophenotyping.Ethics and disseminationEthical approval has been obtained from the Wales Research Ethics Committee 2 (SPON1752-19, 30 October 2019).Trial registration numberNCT05023954.

Published
2022

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

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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