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

Candelaria de Haro; Ary Serpa Neto; Gemma Gomà; Maria Elena González; Alfonso Ortega; Catalina Forteza; Fernando Frutos-Vivar; Raquel García; Fabienne D Simonis; Federico Gordo-Vidal; David Suarez; Marcus J Schultz; Antonio Artigas

doi:10.3389/fmed.2023.1172434

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

Front Med (Lausanne). 2023 Jun 7:10:1172434. doi: 10.3389/fmed.2023.1172434. eCollection 2023.

Authors

Candelaria de Haro^{1

2}, Ary Serpa Neto^{3

4

5

6}, Gemma Gomà¹, Maria Elena González⁷, Alfonso Ortega⁸, Catalina Forteza⁹, Fernando Frutos-Vivar¹⁰, Raquel García¹¹, Fabienne D Simonis³, Federico Gordo-Vidal¹², David Suarez¹, Marcus J Schultz^{3

13

14

15}, Antonio Artigas^{1

2}

Affiliations

¹ Intensive Care Department, Hospital Universitari Parc Taulí, Institut d'Investigació i Innovació Parc Taulí (I3PT-CERCA), Universitat Autònoma de Barcelona, Sabadell, Spain.
² CIBER Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.
³ Department of Intensive Care, Amsterdam University Medical Centers, Location 'AMC', Amsterdam, Netherlands.
⁴ Department of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil.
⁵ Department of Critical Care Medicine, Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), Monash University, Melbourne, VIC, Australia.
⁶ Department of Critical Care, Data Analytics Research and Evaluation (DARE) Centre, Austin Hospital, Melbourne, VIC, Australia.
⁷ Intensive Care Unit, Hospital Universitario de Torrejón, Madrid, Spain.
⁸ Intensive Care Unit, Hospital Universitario Puerta de Hierro, Majadahonda, Spain.
⁹ Intensive Care Unit, Hospital Son Llàtzer, Palma de Mallorca, Spain.
¹⁰ Intensive Care Unit, Hospital Universitario de Getafe, Getafe, Spain.
¹¹ Reanimation Unit, Hospital Universitario 12 de Octubre, Madrid, Spain.
¹² Intensive Care Unit, Hospital del Henares, Grupo de Investigación en Patología Crítica de la Universidad Francisco de Vitoria, Pozuelo de Alarcón, Madrid, Spain.
¹³ Department of Medical Affairs, Hamilton Medical AG, Bonaduz, Switzerland.
¹⁴ Mahidol-Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand.
¹⁵ Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.

Abstract

Introduction: There is no consensus on whether invasive ventilation should use low tidal volumes (V_T) 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_T strategy is more effective than an intermediate V_T 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 V_T (≤ 6 mL/kg predicted body weight, PBW) (N = 50) or intermediate V_T (> 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 V_T group and four (9.1%) patients in the intermediate V_T 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 V_T strategy did neither affect the length of ICU and hospital stay nor mortality rates.

Conclusions: In patients at risk for ARDS, a low V_T strategy did not result in a lower incidence of ARDS than an intermediate V_T strategy.Clinical Trial Registration: ClinicalTrials.gov, identifier NCT02070666.

Keywords: ARDS; critical care; intensive care; lung protection; mechanical ventilation; mortality; tidal volume.

Associated data

ClinicalTrials.gov/NCT02070666