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

• Published in: Frontiers in medicine Vol. 10; p. 1172434
• Main Authors: de Haro, Candelaria, Neto, Ary Serpa, Gomà, Gemma, González, Maria Elena, Ortega, Alfonso, Forteza, Catalina, Frutos-Vivar, Fernando, García, Raquel, Simonis, Fabienne D, Gordo-Vidal, Federico, Suarez, David, Schultz, Marcus J, Artigas, Antonio
• Format: Journal Article
• Language: English
• Published: Switzerland Frontiers Media S.A 07.06.2023
• Subjects: ARDS; critical care; intensive care; lung protection; mechanical ventilation; Medicine; tidal volume; intensive care; mechanical ventilation; critical care; mortality; lung protection; tidal volume; ARDS
• ISSN: 2296-858X; 2296-858X
• DOI: 10.3389/fmed.2023.1172434

There is no consensus on whether invasive ventilation should use low tidal volumes (V ) 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 V strategy is more effective than an intermediate V strategy in preventing pulmonary complications. 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 V (≤ 6 mL/kg predicted body weight, PBW) (  = 50) or intermediate V (> 8 mL/kg PBW) (  = 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. 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 V group and four (9.1%) patients in the intermediate V group had developed ARDS (risk ratio, 1.16 [95% CI, 0.62-2.17];  = 0.735). The incidence of pneumonia and severe atelectasis was also not different between the two groups. The use of a low V strategy did neither affect the length of ICU and hospital stay nor mortality rates. In patients at risk for ARDS, a low V strategy did not result in a lower incidence of ARDS than an intermediate V strategy. : ClinicalTrials.gov, identifier NCT02070666.