Matthieu Jabaudon1, Thomas Godet1, Emmanuel Futier1, Jean-Étienne Bazin2, Vincent Sapin3, Laurence Roszyk3, Bruno Pereira4, Jean-Michel Constantin5. 1. Department of Perioperative Medicine, University Hospital of Clermont-Ferrand, 1, place Lucie-Aubrac, 63003 Clermont-Ferrand, France; Université Clermont-Auvergne, CNRS, Inserm, GReD, 63000 Clermont-Ferrand, France. 2. Department of Perioperative Medicine, University Hospital of Clermont-Ferrand, 1, place Lucie-Aubrac, 63003 Clermont-Ferrand, France. 3. Université Clermont-Auvergne, CNRS, Inserm, GReD, 63000 Clermont-Ferrand, France; Department of Medical Biochemistry and Molecular Biology, University Hospital of Clermont-Ferrand, place Henri-Dunant, 63000 Clermont-Ferrand, France. 4. Biostatistics Unit, Department of Clinical Research and Innovation (DRCI), University Hospital of Clermont-Ferrand, place Henri-Dunant, 63000 Clermont-Ferrand, France. 5. Department of Perioperative Medicine, University Hospital of Clermont-Ferrand, 1, place Lucie-Aubrac, 63003 Clermont-Ferrand, France; Université Clermont-Auvergne, CNRS, Inserm, GReD, 63000 Clermont-Ferrand, France. Electronic address: jmconstantin@chu-clermontferrand.fr.
Abstract
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.
RCT Entities:
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.
Authors: Maurizio Cereda; Yi Xin; Alberto Goffi; Jacob Herrmann; David W Kaczka; Brian P Kavanagh; Gaetano Perchiazzi; Takeshi Yoshida; Rahim R Rizi Journal: Anesthesiology Date: 2019-09 Impact factor: 7.892