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ClinicalTrials.gov ID

NCT07791225

Lead Sponsor

Brigham and Women's HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

20Estimated

Last Update Posted

Aug 27, 2026Actual

Start Date

Feb 1, 2027Estimated

Primary Completion Date

Feb 1, 2031Estimated

Completion Date

Aug 31, 2031Estimated

Official Title

A Bayesian, Operationally Seamless Adaptive Phase 2A/2B, Open-label, Multi-center, Randomized, Two-part Trial to Evaluate the Safety, Efficacy, and Optimal Tidal Volume Distribution of Variable Ventilation (VV) in Participants Undergoing Mechanical Ventilatory Support for Acute Respiratory Distress Syndrome

Brief Summary

The goal of this clinical trial is to learn if a breathing machine (ventilator) method called "variable ventilation" can help protect the lungs of adult patients with acute respiratory distress syndrome (ARDS) who need help breathing through a ventilator. In variable ventilation, the size of each breath given by the machine changes slightly from breath to breath, instead of staying the same size in every breath. The study has two parts, A (safety and feasibility) and B (efficacy). This entry will cover the part A (safety study).

The main questions part A aims to answer are:

1. Is variable ventilation safe to use in adults with ARDS?
2. Is it feasible to deliver this method of ventilation to patients?

Researchers will compare variable ventilation to the standard breathing machine method used today to see if variable ventilation is safe and feasible.

Participants will be placed on an FDA approved ventilator that can deliver conventional mechanical ventilation and variable ventilation. Participants will:

• Have a period of stabilization on conventional ventilation, followed by 24 hours of variable ventilation, followed by 24 hours of conventional ventilation.
• Be checked regularly for breathing, oxygen levels, lung function, and plasma biomarkers.

• ARDS (Acute Respiratory Distress Syndrome)

• Variable Ventilation
• Conventional Ventilation

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Patients ≥21 years old admitted to the Surgical, Trauma, Burn, Coronary or Medical ICUs with ARDS according to the Berlin criteria [50] and requiring mechanical ventilation will be eligible for inclusion.

2. Not more than 96 hours of mechanical ventilation before randomization

3. Anticipated need for at least 48 more hours of controlled mechanical ventilation

4. Intubated and mechanically ventilated for ARDS according to the Berlin criteria

   • Hypoxemia of acute onset, within the past 7 days
   • Mild or moderate hypoxemia, PaO2/FiO2 ratio 100 - 300 mm Hg
   • Presence of a risk factor for ARDS
   • Respiratory failure not fully explained by cardiac failure or fluid overload
   • Bilateral opacities not explained by effusions, lobar collapse, or nodules

Exclusion Criteria:

Demographic

1. Age less than 21 years

2. Pregnant or breastfeeding

3. Prisoner

4. Concurrent participation in another investigational drug study

5. Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if they would receive all supportive care except for attempts at resuscitation from cardiac arrest)

6. No consent or inability to obtain consent or appropriate legal representative not available

7. Physician refusal to allow enrollment in the trial

8. Moribund patient not expected to survive 24 hours

9. Treating team unwilling to use ARDS network low tidal volume strategy or variable ventilation mode

10. Use, or planned use of ECMO

11. Stroke (ischemic or hemorrhagic) or traumatic brain injury (TBI) within the prior 3 months

12. Burns > 40% total body surface area (TBSA)

13. Severe airway inhalational injury

14. Diffuse alveolar hemorrhage

15. Any of the following hallmarks of Severe COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade 3 or 4

    1. FEV1 < 50% predicted
    2. Resting arterial blood gas values PaO2<55, SaO2<88%, or PaCO2>55
    3. Home invasive or non-invasive ventilation other than for sleep apnea
    4. Cor Pulmonale
    5. Candidate for, or has received, lung volume reduction surgery, bronchoscopic intervention to reduce end-expiratory lung volume, or lung transplantation

16. Any of the following cardiac problems:

    1. Acute myocardial infarction (MI) or acute coronary syndrome within the last 90 days
    2. Coronary artery bypass graft (CABG) surgery within 30 days
    3. Angina pectoris, or use of nitrates, with activities of daily living
    4. Cardiopulmonary disease classified as NYHA class IV

    Physiological Exclusions

17. Evidence of current barotrauma (e.g., pneumothorax, pneumomediastinum, or subcutaneous emphysema)

18. Hemodynamic instability defined by inability to maintain a mean arterial pressure > 60 mm Hg.

19. Other respiratory instability PEEP ≥18 cmH2O, suctioning more than hourly, Pplateau > 35 cm H2O, severe respiratory acidosis pH<7.25.

20. Increased ICP > 20 cmH2O or mechanism of injury leading to concern for increased ICP

21. Active bleeding with hemodynamic instability.

Primary Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Sequential Assignment

Masking

None (Open Label)

Lead Sponsor

Brigham and Women's HospitalOTHER

Collaborators

Baystate Medical CenterOTHER

Boston UniversityOTHER

Oregon Health and Science UniversityOTHER

University of Alabama at BirminghamOTHER

landrea@montefiore.org314-705-0925