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.
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).


METHODS
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.
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.
Matthieu
M
Jabaudon
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.
Thomas
T
Godet
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.
Emmanuel
E
Futier
Department of Perioperative Medicine, University Hospital of Clermont-Ferrand, 1, place Lucie-Aubrac, 63003 Clermont-Ferrand, France.
Jean-Étienne
JÉ
Bazin
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.
Vincent
V
Sapin
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.
Laurence
L
Roszyk
Biostatistics Unit, Department of Clinical Research and Innovation (DRCI), University Hospital of Clermont-Ferrand, place Henri-Dunant, 63000 Clermont-Ferrand, France.
Bruno
B
Pereira
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.
Jean-Michel
JM
Constantin
D000328:Adult; D000368:Aged; D001835:Body Weight; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008168:Lung / Q000033:anatomy & histology* / Q000000981:diagnostic imaging*; D008297:Male; D008875:Middle Aged; D010100:Oxygen / Q000008:administration & dosage; D011175:Positive-Pressure Respiration / Q000592:standards; D016684:Prone Position; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D012121:Respiration, Artificial / Q000592:standards*; D012128:Respiratory Distress Syndrome / Q000000981:diagnostic imaging* / Q000401:mortality / Q000628:therapy*; D013990:Tidal Volume; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014463:Ultrasonography; D012122:Ventilators, Mechanical / Q000592:standards*
D010100:Oxygen
ARDS; ARDS phenotype; Lung morphology; Mechanical ventilation; Personalized medicine