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Device

Noninvasive Ventilation Modes for Hypercapnic Respiratory Failure

N/A
Recruiting
Led By Margarita Oks, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with hypercapnic respiratory failure on admission (ABG)
Requiring noninvasive ventilation as determined by the treating physician for the treatment of hypercarbic respiratory failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial compares two modes of noninvasive ventilation to find which is more effective for treating hypercapnic respiratory failure.

Who is the study for?
This trial is for adults over 18 with hypercapnic respiratory failure who need noninvasive ventilation. They must consent to study procedures and be available throughout the study. Excluded are those without spontaneous breathing, pregnant women, intubated patients, individuals unable to clear airways or at risk of aspiration.Check my eligibility
What is being tested?
The study compares two noninvasive ventilation methods: AVAPS and BIPAP S/T in treating hypercapnic respiratory failure. It aims to see if AVAPS reduces ICU or telemetry stay compared to BIPAP S/T, which is a standard care approach.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the masks, skin irritation where the mask touches the face, dry mouth or nosebleeds due to airflow pressure, and possible stomach bloating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was diagnosed with too much carbon dioxide in my blood when admitted.
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I need a machine to help me breathe due to high CO2 levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ICU length of stay of telemetry length of stay
Secondary outcome measures
Days on NIV
Difference in PaCO2 value with NIV
Need for ICU stay
+9 more

Trial Design

2Treatment groups
Active Control
Group I: Average Volume-Assured Pressure Support (AVAPS)Active Control1 Intervention
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.
Group II: Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T)Active Control1 Intervention
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Hypercapnic Respiratory Failure, such as AVAPS and BiPAP S/T, work by enhancing ventilation and improving gas exchange. AVAPS adjusts pressure support to maintain a target tidal volume, ensuring consistent ventilation and preventing CO2 retention. BiPAP S/T provides two levels of pressure support: higher during inhalation to assist breathing in and lower during exhalation to facilitate easier breathing out. These mechanisms reduce the work of breathing and help manage hypercapnia by maintaining adequate alveolar ventilation and reducing CO2 levels, which is crucial for improving respiratory function in hypercapnic patients.
Noninvasive mechanical ventilation with average volume assured pressure support (AVAPS) in patients with chronic obstructive pulmonary disease and hypercapnic encephalopathy.Continuous positive airway pressure versus bilevel noninvasive ventilation in acute cardiogenic pulmonary edema: a randomized multicenter trial.Noninvasive ventilation: experience at a community teaching hospital.

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
461 Previous Clinical Trials
471,035 Total Patients Enrolled
Margarita Oks, MDPrincipal InvestigatorLenox Hill Hospital/Northwell Health
~65 spots leftby Sep 2025