Jacob Rosén1, Erik von Oelreich2,3, Diddi Fors4, Malin Jonsson Fagerlund2,3, Knut Taxbro5, Paul Skorup6, Ludvig Eby7, Francesca Campoccia Jalde2,8, Niclas Johansson9,10, Gustav Bergström6, Peter Frykholm4. 1. Department of Surgical Sciences, Section of Anaesthesiology and Intensive Care Medicine, Uppsala University, Entrance 78, 1 floor, 751 85, Uppsala, Sweden. jacob.rosen@surgsci.uu.se. 2. Perioperative Medicine and Intensive Care, Karolinska University Hospital, Solna, Sweden. 3. Department of Physiology and Pharmacology, Section of Anesthesiology and Intensive Care Medicine, Karolinska Institutet, Solna, Sweden. 4. Department of Surgical Sciences, Section of Anaesthesiology and Intensive Care Medicine, Uppsala University, Entrance 78, 1 floor, 751 85, Uppsala, Sweden. 5. Department of Anaesthesiology and Intensive Care Medicine, Ryhov County Hospital, Jönköping, Sweden. 6. Department of Medical Sciences, Section of Infectious Diseases, Uppsala University, Uppsala, Sweden. 7. Acute and Reparative Medicine, Karolinska University Hospital, Solna, Sweden. 8. Department of Molecular Medicine and Surgery, Section of Thoracic Anesthesiology and Intensive Care, Karolinska Institutet, Solna, Sweden. 9. Department of Infectious Diseases, Karolinska University Hospital, Solna, Sweden. 10. Infectious Diseases Unit, Department of Medicine, Karolinska Institutet, Solna, Sweden.
Abstract
BACKGROUND: The effect of awake prone positioning on intubation rates is not established. The aim of this trial was to investigate if a protocol for awake prone positioning reduces the rate of endotracheal intubation compared with standard care among patients with moderate to severe hypoxemic respiratory failure due to COVID-19. METHODS: We conducted a multicenter randomized clinical trial. Adult patients with confirmed COVID-19, high-flow nasal oxygen or noninvasive ventilation for respiratory support and a PaO2/FiO2 ratio ≤ 20 kPa were randomly assigned to a protocol targeting 16 h prone positioning per day or standard care. The primary endpoint was intubation within 30 days. Secondary endpoints included duration of awake prone positioning, 30-day mortality, ventilator-free days, hospital and intensive care unit length of stay, use of noninvasive ventilation, organ support and adverse events. The trial was terminated early due to futility. RESULTS: Of 141 patients assessed for eligibility, 75 were randomized of whom 39 were allocated to the control group and 36 to the prone group. Within 30 days after enrollment, 13 patients (33%) were intubated in the control group versus 12 patients (33%) in the prone group (HR 1.01 (95% CI 0.46-2.21), P = 0.99). Median prone duration was 3.4 h [IQR 1.8-8.4] in the control group compared with 9.0 h per day [IQR 4.4-10.6] in the prone group (P = 0.014). Nine patients (23%) in the control group had pressure sores compared with two patients (6%) in the prone group (difference - 18% (95% CI - 2 to - 33%); P = 0.032). There were no other differences in secondary outcomes between groups. CONCLUSIONS: The implemented protocol for awake prone positioning increased duration of prone positioning, but did not reduce the rate of intubation in patients with hypoxemic respiratory failure due to COVID-19 compared to standard care. TRIAL REGISTRATION: ISRCTN54917435. Registered 15 June 2020 ( https://doi.org/10.1186/ISRCTN54917435 ).
RCT Entities:
BACKGROUND: The effect of awake prone positioning on intubation rates is not established. The aim of this trial was to investigate if a protocol for awake prone positioning reduces the rate of endotracheal intubation compared with standard care among patients with moderate to severe hypoxemic respiratory failure due to COVID-19. METHODS: We conducted a multicenter randomized clinical trial. Adult patients with confirmed COVID-19, high-flow nasal oxygen or noninvasive ventilation for respiratory support and a PaO2/FiO2 ratio ≤ 20 kPa were randomly assigned to a protocol targeting 16 h prone positioning per day or standard care. The primary endpoint was intubation within 30 days. Secondary endpoints included duration of awake prone positioning, 30-day mortality, ventilator-free days, hospital and intensive care unit length of stay, use of noninvasive ventilation, organ support and adverse events. The trial was terminated early due to futility. RESULTS: Of 141 patients assessed for eligibility, 75 were randomized of whom 39 were allocated to the control group and 36 to the prone group. Within 30 days after enrollment, 13 patients (33%) were intubated in the control group versus 12 patients (33%) in the prone group (HR 1.01 (95% CI 0.46-2.21), P = 0.99). Median prone duration was 3.4 h [IQR 1.8-8.4] in the control group compared with 9.0 h per day [IQR 4.4-10.6] in the prone group (P = 0.014). Nine patients (23%) in the control group had pressure sores compared with two patients (6%) in the prone group (difference - 18% (95% CI - 2 to - 33%); P = 0.032). There were no other differences in secondary outcomes between groups. CONCLUSIONS: The implemented protocol for awake prone positioning increased duration of prone positioning, but did not reduce the rate of intubation in patients with hypoxemic respiratory failure due to COVID-19 compared to standard care. TRIAL REGISTRATION: ISRCTN54917435. Registered 15 June 2020 ( https://doi.org/10.1186/ISRCTN54917435 ).
Authors: Waleed Alhazzani; Ken Kuljit S Parhar; Jason Weatherald; Zainab Al Duhailib; Mohammed Alshahrani; Abdulrahman Al-Fares; Sarah Buabbas; Sujith V Cherian; Laveena Munshi; Eddy Fan; Fahad Al-Hameed; Jamal Chalabi; Amera A Rahmatullah; Erick Duan; Jennifer L Y Tsang; Kimberley Lewis; François Lauzier; John Centofanti; Bram Rochwerg; Sarah Culgin; Katlynne Nelson; Sheryl Ann Abdukahil; Kirsten M Fiest; Henry T Stelfox; Haytham Tlayjeh; Maureen O Meade; Dan Perri; Kevin Solverson; Daniel J Niven; Rachel Lim; Morten Hylander Møller; Emilie Belley-Cote; Lehana Thabane; Hani Tamim; Deborah J Cook; Yaseen M Arabi Journal: JAMA Date: 2022-06-07 Impact factor: 157.335
Authors: João Manoel Silva Junior; Ricardo Esper Treml; Pamela Cristina Golinelli; Miguel Rogério de Melo Gurgel Segundo; Pedro Ferro L Menezes; Julilane Daniele de Almeida Umada; Ana Paula Santana Alves; Renata Peres Nabeshima; André Dos Santos Carvalho; Talison Silas Pereira; Elaine Serafim Sponton Journal: Clinics (Sao Paulo) Date: 2021-12-10 Impact factor: 2.365
Authors: L Morales-Quinteros; M J Schultz; A Serpa-Neto; M Antonelli; D L Grieco; O Roca; N P Juffermans; C de Haro; D de Mendoza; Ll Blanch; M Camprubí-Rimblas; Gemma Gomà; A Artigas-Raventós Journal: Trials Date: 2022-01-10 Impact factor: 2.279
Authors: Ramandeep Kaur; David L Vines; Sara Mirza; Ahmad Elshafei; Julie A Jackson; Lauren J Harnois; Tyler Weiss; J Brady Scott; Matthew W Trump; Idrees Mogri; Flor Cerda; Amnah A Alolaiwat; Amanda R Miller; Andrew M Klein; Trevor W Oetting; Lindsey Morris; Scott Heckart; Lindsay Capouch; Hangyong He; Jie Li Journal: Crit Care Date: 2021-09-17 Impact factor: 9.097
Authors: Jacob Rosén; Erik von Oelreich; Diddi Fors; Malin Jonsson Fagerlund; Knut Taxbro; Peter Frykholm Journal: Crit Care Date: 2021-08-04 Impact factor: 9.097