Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeth Israel Deaconess Medical Center
About this trial
The goal of this interventional study is to compare standard mechanical ventilation to a lung-stress oriented ventilation strategy in patients with Acute Respiratory Distress Syndrome (ARDS). Participants will be ventilated according to one of two different strategies. The main question the study hopes to answer is whether the personalized ventilation strategy helps improve survival.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Invasive ventilation with positive end-expiratory pressure (PEEP) ≥ 8 cm H2O or FiO2 ≥ 0.5
Bilateral lung opacities on chest imaging not fully explained by effusions, lobar collapse, or nodules
Respiratory failure not fully explained by heart failure or fluid overload
Disqualifiers
Esophageal manometry already in use clinically
Severe brain injury: including suspected elevated intracranial pressure, cerebral edema, or Glasgow coma score (GCS) ≤ 8 directly caused by severe brain injury (e.g., ischemia or hemorrhage)
Gross barotrauma or chest tube inserted to treat barotrauma (note: chest tube inserted strictly for drainage of pleural effusion is not an exclusion)
Esophageal pathology that, in judgement of the site investigator, significantly increases risk of esophageal catheter placement, including high-risk esophageal varices, recent oropharyngeal or gastroesophageal surgery; or past esophagectomy
Trial design
Design model
Parallel
Treatments tested in this trial
Precision ventilation
Other interventionThe intervention arm prioritizes mitigation of ventilator-induced-lung-injury by individualizing support to patient-specific mechanics in an integrated approach to limit overdistension and atelectrauma. This is accomplished in this arm by titration of tidal volume to limitation of driving pressure at 12 centimeters of water (cmH2O) or less and using esophageal manometry to titrate PEEP to a transpulmonary pressure of 0 cmH2O with adjustments in respiratory rate to allow for permissive hypercapnia and FiO2 adjustments to assure adequate oxygenation.
Guided usual care ventilation
Other interventionThe comparison arm allows clinician discretion when titrating PEEP and tidal volume, while setting general targets for allowable PEEP/FiO2 combinations, target range for SpO2, and target range for tidal volume. This arm applies routine best-practice guidelines. This includes maintenance of tidal volumes of 6-8 cc/kg of ideal body weight, limiting plateau pressures to 30 cmH2O or less and application of PEEP-FiO2 combinations which include a wide range of typical usual care with esophageal manometry only for data collection and not clinical adjustment.
Treatment groups
1,100 Participants
are divided into 2 treatment groupsGroup A: Precision ventilationExperimental treatment 1 intervention
Group B: Guided usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
60-day mortality
All-cause, all-location mortality
Time frame
60 days from randomizationSecondary outcomes
1
28-day mortality
All-cause, all-location mortality
Time frame
28 days from randomization2
Alive and ventilator-free through 28 days
A composite outcome that incorporates survival for the defined follow-up interval and time to successful liberation from invasive mechanical ventilation (IMV) among survivors.
Time frame
28 days from randomization3
Alive and Respiratory Support-Free
A composite outcome that incorporates survival for the defined follow-up interval and time to successful liberation from advanced respiratory support among survivors. Advanced respiratory support is defined in Section 1.2. This outcome will be formulated as a win ratio and separately as a time-to-event competing risk endpoint.
Time frame
28 days from randomization4
Barotrauma through Day 14
Any occurrence of pneumothorax, pneumomediastinum, subcutaneous emphysema, or chest tube insertion for barotrauma through Day 14 or until successful liberation from IMV, whichever occurs first.
Time frame
14 days from randomizationOther outcomes
1
Hemodynamic Instability Index through Hour 4 and daily through Day 7
A hemodynamic instability index will be computed per a six-level ordinal scale
Time frame
From hour 4 through Day 7 from randomization2
Shock-free days through Day 28
The number of days, regardless of consecutiveness, during which vasopressors have not been administered for at least 1 uninterrupted hour, through Day 28.
Time frame
28 days from randomization3
Renal failure-free days through Day 28
The number of days between successful liberation from renal replacement therapy and Day 28.
Time frame
28 days from randomization4
Refractory hypoxemia through Day 14
Any occurrence of SpO2 \< 88% continuously for at least 30 minutes' duration despite valid pulse-oximetry waveform and protocol-directed ventilatory support, through Day 28 or until successful liberation from IMV, whichever occurs first.
Time frame
14 days from randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beth Israel Deaconess Medical Center
Lead sponsor
NYU Langone Health
Collaborator
Massachusetts General Hospital
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov