Rationale, study design and analysis plan of the lung imaging morphology for ventilator settings in acute respiratory distress syndrome study (LIVE study): Study protocol for a randomised controlled trial

Anaesth Crit Care Pain Med. 2017 Oct;36(5):301-306. doi: 10.1016/j.accpm.2017.02.006. Epub 2017 Mar 18.


Different acute respiratory distress syndrome (ARDS) phenotypes may explain controversial results in clinical trials. Lung-morphology is one of the ARDS-phenotypes and physiological studies suggest different responses in terms of positive-end-expiratory-pressure (PEEP) and recruitment-manoeuvres (RM) according to loss of aeration. To evaluate whether tailored ventilator regimens may impact ARDS outcomes, our group has designed a randomised-clinical-trial of ventilator settings according to lung morphology in moderate-to-severe ARDS (LIVE study).

Method: Patients will be enrolled within the first 12hours of ARDS onset. In both groups, volume-controlled ventilation with low tidal-volumes (Vt) will be used to target a plateau pressure≤30 cmH2O. In the control group, the PEEP level and inspired fraction of oxygen (FiO2) will be set using the ARDSNet table; a Vt of 6 mL/kg of predicted body weight (PBW) will be set and prone position (PP) will be applied. In the intervention arm, the ventilator will be set according to lung morphology (focal/non-focal) that will be assessed according to CT-scan±chest x-ray+lung echography. For focal ARDS patients, a Vt of 8 mL/kg PBW will be used along with low PEEP and PP. For non-focal ARDS patients, a Vt of 6 mL/kg PBW will be used with RM and PEEP to reach a plateau pressure≤30 cmH2O. The primary outcome is all-cause 90-day mortality and the secondary outcomes are: in-hospital mortality, mortality at day 28, 60, 180 and 365; ventilator-free days at day 30, quality of life at one year; ventilator-associated pneumonia rate; barotrauma; ICU and hospital length of stay. This RCT is registered on Clinicaltrials.gov under identifier NCT02149589.

Keywords: ARDS; ARDS phenotype; Lung morphology; Mechanical ventilation; Personalized medicine.

MeSH terms

  • Adult
  • Aged
  • Body Weight
  • Female
  • Hospital Mortality
  • Humans
  • Kaplan-Meier Estimate
  • Lung / anatomy & histology*
  • Lung / diagnostic imaging*
  • Male
  • Middle Aged
  • Oxygen / administration & dosage
  • Positive-Pressure Respiration / standards
  • Prone Position
  • Randomized Controlled Trials as Topic / methods*
  • Research Design
  • Respiration, Artificial / standards*
  • Respiratory Distress Syndrome / diagnostic imaging*
  • Respiratory Distress Syndrome / mortality
  • Respiratory Distress Syndrome / therapy*
  • Tidal Volume
  • Tomography, X-Ray Computed
  • Treatment Outcome
  • Ultrasonography
  • Ventilators, Mechanical / standards*


  • Oxygen

Associated data

  • ClinicalTrials.gov/NCT02149589