Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Sep 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different ways of helping patients with Acute Respiratory Distress Syndrome (ARDS), a serious condition that affects breathing. The trial aims to find out if a personalized ventilation strategy, which adjusts breathing support to each patient’s needs, can improve survival compared to standard mechanical ventilation, which is a more general approach. The study is currently looking for participants aged 18 and older who are experiencing moderate to severe ARDS and have started receiving breathing support within the past few days.

If you or a loved one might be eligible, participants will be assigned to one of the two ventilation strategies and monitored closely throughout the trial. The researchers hope that by comparing these two methods, they can learn which one is more effective for helping patients recover from ARDS. It's important to note that there are certain health conditions that may exclude someone from participating, such as severe brain injuries or certain types of respiratory diseases. Overall, this study is focused on improving care for patients with ARDS, and participation could contribute to important findings in this area.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years
• 2. Moderate or severe ARDS, defined as meeting all of the following (a-e):
• • 1. Invasive ventilation with positive end-expiratory pressure (PEEP) ≥ 5 cm H2O
• 2. Hypoxemia as characterized by: • If arterial blood gas (ABG) available: the partial pressure of oxygen in the arterial blood (PaO2)/FiO2 ≤ 200 mm Hg, or, • if ABG not available OR overt clinical deterioration in oxygenation since last ABG: SpO2/FiO2 ≤ 235 with SpO2 ≤ 97% (both conditions) on two representative assessments between 1 to 6 hours apart. • If patient is positioned prone or receiving inhaled pulmonary vasodilator at time of screening:
• Qualifying PaO2/FiO2 or SpO2/FiO2 (as defined above) that was recorded within the 6 hours immediately prior to initiating either of these therapies may be used for eligibility determination. • If PEEP has been increased by \> 5 cm H2O within the last 12 hours immediately prior to screening:
• • Qualifying PaO2/FiO2 or SpO2/FiO2 (as defined above) prior to PEEP increase may be used for eligibility determination if recorded within this 12-hour window.
• • 3. Bilateral lung opacities on chest imaging not fully explained by effusions, lobar collapse, or nodules
• • 4. Respiratory failure not fully explained by heart failure or fluid overload
• • 5. Onset within 1 week of clinical insult or new/worsening symptoms
• • 3. Early in ARDS course
• • Full criteria for moderate-severe ARDS (#2 above) first met within previous 3 days
• • Current invasive ventilation episode not more than 4 days duration
• • Current severe hypoxemic episode (receipt of invasive ventilation, noninvasive ventilation, or high-flow nasal cannula) not more than 10 days duration
• Exclusion Criteria:
• • 1. Esophageal manometry already in use clinically
• • 2. 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)
• • 3. Gross barotrauma or chest tube inserted to treat barotrauma (note: chest tube inserted strictly for drainage of pleural effusion is not an exclusion)
• • 4. Esophageal varix or stricture that, in judgement of the site investigator, significantly increases risk of esophageal catheter placement; recent oropharyngeal or gastroesophageal surgery; or past esophagectomy
• • 5. Ongoing severe coagulopathy (platelet \< 5000/μL or INR \> 4)
• • 6. Extracorporeal membrane oxygenation (ECMO) or CO2 removal (ECCO2R)
• • 7. Neuromuscular disease that impairs spontaneous breathing (including but not limited to amyotrophic lateral sclerosis, Guillain-Barré syndrome, spinal cord injury at C5 or above)
• • 8. Any of the following severe chronic lung diseases: continuous home supplemental oxygen \> 3 liters/minute, pulmonary fibrosis, cystic fibrosis, lung transplant, or acute exacerbation of a chronic interstitial lung disease (ILD)
• • 9. Severe shock: norepinephrine-equivalent dose ≥ 0.6 μg/kg/min or simultaneous receipt of ≥ 3 vasopressors
• • 10. Severe liver disease, defined as Child-Pugh Class C (Section 12.3)
• • 11. ICU admission for burn injury
• • 12. Current ICU stay \> 2 weeks or acute care hospital stay \> 4 weeks
• • 13. Estimated mortality \> 50% over 6 months due to underlying chronic medical condition (e.g. metastatic pancreatic cancer) as assessed by the study physician
• • 14. Moribund patient not expected to survive 24 hours as assessed by the study physician; if cardiopulmonary resuscitation (CPR) was provided, assessment for moribund status must occur at least 6 hours after CPR was completed
• • 15. Current limitation on life-sustaining care (other than do-not-resuscitate), or expectation by clinical team that a limitation on life-sustained care will be adopted within next 24 hours.
• • 16. Treating clinician refusal or unwilling to use protocol-specified ventilator settings/modes
• • 17. Prisoner
• • 18. Previous enrollment in this trial