NIV for Hypercapnic Respiratory Failure: AVAPS vs S/T BIPAP
Part of paid clinical trials in New York, New York.
- Sponsor
- Northwell Health
- Study ID
- NCT06047405
- Status
- Recruiting
Conditions
- Hypercapnic Respiratory Failure
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Average Volume-Assured Pressure Support (AVAPS) — DEVICEA setting on noninvasive ventilator that allows setting of maximum and minimum inspiratory pressure and sets a target tidal volume. The inspiratory pressure varies breath to breath to ensure pre-set tidal volume is delivered.
- Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T) — DEVICEA setting on noninvasive ventilator that allows setting of inspiratory pressure, inspiratory time, expiratory pressure, and backup rate to deliver variable tidal volumes.
Study Details
The goal of this study is to compare two different modes of noninvasive ventilation in hypercapnic respiratory failure. The investigators will compare AVAPS and BIPAP S/T and hypothesize that AVAPS will result in a decreased length of stay in the ICU or on telemetry. Currently, noninvasive ventilation is the standard of care for hypercapnic respiratory failure. However, the most effective mode for patients with hypercapnic respiratory failure is unclear.
Key Dates
- Start date
- Oct 7, 2023
- Status verified
- Oct 2023
- Primary completion
- Sep 28, 2025
- Completion
- Sep 1, 2026
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Average Volume-Assured Pressure Support (AVAPS)Average Volume-Assured Pressure Support (AVAPS) setting on the noninvasive ventilator. The exact AVAPS setting will be titrated by the clinical team involved directly in the patient's care based on patient comfort and clinical response.
- Active Comparator: Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T)Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T) setting on the noninvasive ventilator. The exact BIPAP S/T setting will be titrated by the clinical team involved directly in the patient's care based on patient comfort and clinical response.
Primary Outcome Measure
ICU length of stay of telemetry length of stay [ Time Frame: within one week of hospital discharge (5-7 days) ]
Central Contacts
- Sara Velichkovikj(212)-434-4087
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Lenox Hill Hospital | New York | New York | 10075 | Zein Kattih, MD (SUB_INVESTIGATOR) |
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