TY - JOUR
T1 - Effect of a low versus intermediate tidal volume strategy on pulmonary complications in patients at risk of acute respiratory distress syndrome—a randomized clinical trial
AU - de Haro, Candelaria
AU - Neto, Ary Serpa
AU - Gomà, Gemma
AU - González, Maria Elena
AU - Ortega, Alfonso
AU - Forteza, Catalina
AU - Frutos-Vivar, Fernando
AU - García, Raquel
AU - Simonis, Fabienne D.
AU - Gordo-Vidal, Federico
AU - Suarez, David
AU - Schultz, Marcus J.
AU - Artigas, Antonio
N1 - Funding Information: The authors would like to thank all investigators from the participating centers: Cecilia Hermosa and FG-V, Hospital Universitario del Henares, Coslada, Spain; MG and MªCruz Martín, Hospital de Torrejón, Torrejón de Ardoz, Spain; AO, María Arís Pérez Lucendo, and Daniel Ballesteros Ortega, Hospital Universitario Puerta de Hierro, Madrid, Spain; FF-V, Hospital de Getafe, Getafe, Spain; CF and Gemma Rialp, Hospital Son Llàtzer, Mallorca, Spain; David Kauffman, Bridgeport Hospital, New York, USA; Roser Tomàs, Hospital General de Catalunya, Sant Cugat del Vallés, Spain; José Antonio Carbonell, Hospital Clínico Universitario de Valencia, Valencia, Spain; and RG, Unidad de Reanimación, Hospital 12 de Octubre, Madrid, Spain. They would also like to thank all of the patients, as this study would not have been possible without their consent. Publisher Copyright: Copyright © 2023 de Haro, Neto, Gomà, González, Ortega, Forteza, Frutos-Vivar, García, Simonis, Gordo-Vidal, Suarez, Schultz and Artigas.
PY - 2023
Y1 - 2023
N2 - Introduction: There is no consensus on whether invasive ventilation should use low tidal volumes (VT) to prevent lung complications in patients at risk of acute respiratory distress syndrome (ARDS). The purpose of this study is to determine if a low VT strategy is more effective than an intermediate VT strategy in preventing pulmonary complications. Methods: A randomized clinical trial was conducted in invasively ventilated patients with a lung injury prediction score (LIPS) of >4 performed in the intensive care units of 10 hospitals in Spain and one in the United States of America (USA) from 3 November 2014 to 30 August 2016. Patients were randomized to invasive ventilation using low VT (≤ 6 mL/kg predicted body weight, PBW) (N = 50) or intermediate VT (> 8 mL/kg PBW) (N = 48). The primary endpoint was the development of ARDS during the first 7 days after the initiation of invasive ventilation. Secondary endpoints included the development of pneumonia and severe atelectases; the length of intensive care unit (ICU) and hospital stay; and ICU, hospital, 28– and 90–day mortality. Results: In total, 98 patients [67.3% male], with a median age of 65.5 years [interquartile range 55–73], were enrolled until the study was prematurely stopped because of slow recruitment and loss of equipoise caused by recent study reports. On day 7, five (11.9%) patients in the low VT group and four (9.1%) patients in the intermediate VT group had developed ARDS (risk ratio, 1.16 [95% CI, 0.62–2.17]; p = 0.735). The incidence of pneumonia and severe atelectasis was also not different between the two groups. The use of a low VT strategy did neither affect the length of ICU and hospital stay nor mortality rates. Conclusions: In patients at risk for ARDS, a low VT strategy did not result in a lower incidence of ARDS than an intermediate VT strategy. Clinical Trial Registration: ClinicalTrials.gov, identifier NCT02070666.
AB - Introduction: There is no consensus on whether invasive ventilation should use low tidal volumes (VT) to prevent lung complications in patients at risk of acute respiratory distress syndrome (ARDS). The purpose of this study is to determine if a low VT strategy is more effective than an intermediate VT strategy in preventing pulmonary complications. Methods: A randomized clinical trial was conducted in invasively ventilated patients with a lung injury prediction score (LIPS) of >4 performed in the intensive care units of 10 hospitals in Spain and one in the United States of America (USA) from 3 November 2014 to 30 August 2016. Patients were randomized to invasive ventilation using low VT (≤ 6 mL/kg predicted body weight, PBW) (N = 50) or intermediate VT (> 8 mL/kg PBW) (N = 48). The primary endpoint was the development of ARDS during the first 7 days after the initiation of invasive ventilation. Secondary endpoints included the development of pneumonia and severe atelectases; the length of intensive care unit (ICU) and hospital stay; and ICU, hospital, 28– and 90–day mortality. Results: In total, 98 patients [67.3% male], with a median age of 65.5 years [interquartile range 55–73], were enrolled until the study was prematurely stopped because of slow recruitment and loss of equipoise caused by recent study reports. On day 7, five (11.9%) patients in the low VT group and four (9.1%) patients in the intermediate VT group had developed ARDS (risk ratio, 1.16 [95% CI, 0.62–2.17]; p = 0.735). The incidence of pneumonia and severe atelectasis was also not different between the two groups. The use of a low VT strategy did neither affect the length of ICU and hospital stay nor mortality rates. Conclusions: In patients at risk for ARDS, a low VT strategy did not result in a lower incidence of ARDS than an intermediate VT strategy. Clinical Trial Registration: ClinicalTrials.gov, identifier NCT02070666.
KW - ARDS
KW - critical care
KW - intensive care
KW - lung protection
KW - mechanical ventilation
KW - mortality
KW - tidal volume
UR - http://www.scopus.com/inward/record.url?scp=85163359303&partnerID=8YFLogxK
U2 - https://doi.org/10.3389/fmed.2023.1172434
DO - https://doi.org/10.3389/fmed.2023.1172434
M3 - Article
C2 - 37351068
SN - 2296-858X
VL - 10
JO - Frontiers in Medicine
JF - Frontiers in Medicine
M1 - 1172434
ER -