Mark J Peters1,2, Rachel Agbeko3,4, Peter Davis5, Nigel Klein6, Zohra Zenasni7, Amy Jones2, Christine Mackerness3, Susan George5, Paul Veys8, Samiran Ray1,2, Paul R Mouncey7, David A Harrison7, Kathy Rowan7. 1. Respiratory Critical Care and Anaesthesia Unit, UCL Great Ormond Street Institute of Child Health, London, United Kingdom. 2. Paediatric and Neonatal Intensive Care Units, Great Ormond Street Hospital for Children NHS Trust, London, United Kingdom. 3. Paediatric Intensive Care Unit, Great North Children's Hospital, Royal Victoria Infirmary, Newcastle upon Tyne, United Kingdom. 4. Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom. 5. Paediatric Intensive Care Unit, Bristol Royal Hospital for Children, Bristol, United Kingdom. 6. Infectious Disease and Microbiology Unit, UCL Great Ormond Street Institute of Child Health, London, United Kingdom. 7. Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom. 8. Department of Immunology and Bone Marrow Transplantation, Great Ormond Street Hospital, London, United Kingdom.
Abstract
OBJECTIVES: Previous trials in adults with impaired immunity and respiratory failure suggest that early noninvasive ventilation avoids endotracheal intubation and improves survival. No randomized clinical trials have addressed this question in children. DESIGN: We undertook an open, parallel-group randomized trial in three pediatric hospitals. SUBJECTS:Children with impaired immunity and acute respiratory failure defined as tachypnoea (> 90th centile); a new requirement for supplemental oxygen; and new chest radiograph infiltrates. INTERVENTIONS:Children were randomly assigned to early PICU admission for continuous positive airways pressure (early continuous positive airways pressure) or to standard care. The primary outcome was endotracheal intubation by 30 days. MEASUREMENTS AND MAIN RESULTS:One-hundred fourteen children met inclusion criteria of whom 42 were randomized between January 2013 and January 2016. There was no significant difference in endotracheal intubation by 30 days with early continuous positive airways pressure (10/21; 48%) compared with standard care (5/21; 24%), odds ratio 2.9 (0.8-10.9), p value equals to 0.11. However, 30-day mortality was significantly higher with early continuous positive airways pressure (7/21; 33%) compared with standard care (1/21; 5%), odds ratio 10.0 (1.1-90.6), p value equals to 0.041. Mortality at 90 days was early continuous positive airways pressure (11/21; 52%) versus standard care (4/21; 19%), odds ratio 4.7 (1.2-18.6), p value equals to 0.029, whereas mortality at 1 year was similar early continuous positive airways pressure (13/21; 61.9%) versus standard care (9/21; 42.7%), odds ratio 2.2 (0.6-7.4), p value equals to 0.22. There were two serious adverse events: early continuous positive airways pressure (pneumothorax) and standard care (hemothorax). CONCLUSIONS: This study provided no evidence to support early PICU admission for continuous positive airways pressure in children with acute respiratory failure and impaired immunity. There was a trend toward increased endotracheal intubation and a higher early mortality in the early continuous positive airways pressure group.
RCT Entities:
OBJECTIVES: Previous trials in adults with impaired immunity and respiratory failure suggest that early noninvasive ventilation avoids endotracheal intubation and improves survival. No randomized clinical trials have addressed this question in children. DESIGN: We undertook an open, parallel-group randomized trial in three pediatric hospitals. SUBJECTS:Children with impaired immunity and acute respiratory failure defined as tachypnoea (> 90th centile); a new requirement for supplemental oxygen; and new chest radiograph infiltrates. INTERVENTIONS:Children were randomly assigned to early PICU admission for continuous positive airways pressure (early continuous positive airways pressure) or to standard care. The primary outcome was endotracheal intubation by 30 days. MEASUREMENTS AND MAIN RESULTS: One-hundred fourteen children met inclusion criteria of whom 42 were randomized between January 2013 and January 2016. There was no significant difference in endotracheal intubation by 30 days with early continuous positive airways pressure (10/21; 48%) compared with standard care (5/21; 24%), odds ratio 2.9 (0.8-10.9), p value equals to 0.11. However, 30-day mortality was significantly higher with early continuous positive airways pressure (7/21; 33%) compared with standard care (1/21; 5%), odds ratio 10.0 (1.1-90.6), p value equals to 0.041. Mortality at 90 days was early continuous positive airways pressure (11/21; 52%) versus standard care (4/21; 19%), odds ratio 4.7 (1.2-18.6), p value equals to 0.029, whereas mortality at 1 year was similar early continuous positive airways pressure (13/21; 61.9%) versus standard care (9/21; 42.7%), odds ratio 2.2 (0.6-7.4), p value equals to 0.22. There were two serious adverse events: early continuous positive airways pressure (pneumothorax) and standard care (hemothorax). CONCLUSIONS: This study provided no evidence to support early PICU admission for continuous positive airways pressure in children with acute respiratory failure and impaired immunity. There was a trend toward increased endotracheal intubation and a higher early mortality in the early continuous positive airways pressure group.
Authors: Scott L Weiss; Mark J Peters; Waleed Alhazzani; Michael S D Agus; Heidi R Flori; David P Inwald; Simon Nadel; Luregn J Schlapbach; Robert C Tasker; Andrew C Argent; Joe Brierley; Joseph Carcillo; Enitan D Carrol; Christopher L Carroll; Ira M Cheifetz; Karen Choong; Jeffry J Cies; Andrea T Cruz; Daniele De Luca; Akash Deep; Saul N Faust; Claudio Flauzino De Oliveira; Mark W Hall; Paul Ishimine; Etienne Javouhey; Koen F M Joosten; Poonam Joshi; Oliver Karam; Martin C J Kneyber; Joris Lemson; Graeme MacLaren; Nilesh M Mehta; Morten Hylander Møller; Christopher J L Newth; Trung C Nguyen; Akira Nishisaki; Mark E Nunnally; Margaret M Parker; Raina M Paul; Adrienne G Randolph; Suchitra Ranjit; Lewis H Romer; Halden F Scott; Lyvonne N Tume; Judy T Verger; Eric A Williams; Joshua Wolf; Hector R Wong; Jerry J Zimmerman; Niranjan Kissoon; Pierre Tissieres Journal: Intensive Care Med Date: 2020-02 Impact factor: 17.440
Authors: Alvin Richards-Belle; Peter Davis; Laura Drikite; Richard Feltbower; Richard Grieve; David A Harrison; Julie Lester; Kevin P Morris; Paul R Mouncey; Mark J Peters; Kathryn M Rowan; Zia Sadique; Lyvonne N Tume; Padmanabhan Ramnarayan Journal: BMJ Open Date: 2020-08-04 Impact factor: 2.692