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Search / Trial NCT06047405

NIV for Hypercapnic Respiratory Failure: AVAPS vs S/T BIPAP

Launched by NORTHWELL HEALTH · Sep 18, 2023

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

Avaps Bipap Hypercapnic Respiratory Failure Noninvasive Ventilation

ClinConnect Summary

This clinical trial is studying two different types of noninvasive ventilation methods, called AVAPS and BIPAP S/T, for patients with hypercapnic respiratory failure, a condition where there is too much carbon dioxide in the blood. The researchers want to find out if using AVAPS can help patients spend less time in the intensive care unit (ICU) or on telemetry monitoring compared to BIPAP S/T. Noninvasive ventilation is a common treatment for this condition, but it’s not yet clear which method works best for patients.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with hypercapnic respiratory failure when they are admitted to the hospital. They should also be willing to follow the study procedures and provide informed consent, either themselves or through a legal representative. However, certain patients, such as those who are currently intubated or have specific medical conditions like pregnancy or severe respiratory issues, will not be included. If you or a loved one are considering participation, you can expect to receive care using one of the two ventilation methods being studied while contributing to important research that could improve treatment for others in the future.

Gender

ALL

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

About Northwell Health

Northwell Health is a leading integrated health system based in New York, dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to improving patient outcomes and enhancing medical knowledge, Northwell Health conducts a diverse range of clinical studies across various therapeutic areas. The organization harnesses its extensive network of hospitals, outpatient facilities, and research institutes to facilitate cutting-edge research, ensuring access to advanced treatments for patients while fostering collaboration among healthcare professionals, researchers, and industry partners. By prioritizing patient-centric approaches and leveraging state-of-the-art technology, Northwell Health aims to drive significant advancements in medical science and public health.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Margarita Oks, MD

Principal Investigator

Lenox Hill Hospital/Northwell Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported