NCT06047405 NIV for Hypercapnic Respiratory Failure: AVAPS vs S/T BIPAP
| NCT ID | NCT06047405 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwell Health |
| Condition | Hypercapnic Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-10-07 |
| Primary Completion | 2025-09-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-10-07 with a primary completion date of 2025-09-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form directly by the patient; consent can also be obtained via a legal patient representative/health care proxy/surrogate 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 or older 4. Diagnosed with hypercapnic respiratory failure on admission (ABG) 5. Admitted to Lenox Hill Hospital medical intensive care unit or telemetry unit 6. Requiring noninvasive ventilation as determined by the treating physician for the treatment of hypercarbic respiratory failure Exclusion Criteria: 1. Patients who require ventilation at predetermined tidal volumes 2. Patients who require rapid and frequent IPAP adjustments to maintain a consistent tidal volume 3. Age less than 18 years of age 4. Currently intubated 5. Chronic tracheostomy 6. Pregnancy 7. Hypotension 8. Epistaxis (nosebleed) 9. Untreated pertussis 10. Acute sinusitis or Otitis media 11. Patients at risk of aspirating gastric contents 12. Patients with lack of spontaneous respiratory drive 13. Patients with the inability to maintain a patent airway or adequately clear secretions 14. Prisoners or other institutionalized individuals
Contact & Investigator
Margarita Oks, MD
PRINCIPAL INVESTIGATOR
Lenox Hill Hospital/Northwell Health
Frequently Asked Questions
Who can join the NCT06047405 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypercapnic Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06047405 currently recruiting?
Yes, NCT06047405 is actively recruiting participants. Contact the research team at svelichkovik@northwell.edu for enrollment information.
Where is the NCT06047405 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06047405 clinical trial?
NCT06047405 is sponsored by Northwell Health. The principal investigator is Margarita Oks, MD at Lenox Hill Hospital/Northwell Health. The trial plans to enroll 100 participants.