Comparing two noninvasive ventilation methods for treating hypercapnic respiratory failure

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

This study is testing which of two noninvasive breathing methods, AVAPS or BIPAP S/T, works better for adults with breathing problems caused by high carbon dioxide levels.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Northwell Health (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06047405 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness of two noninvasive ventilation modes, Average Volume-Assured Pressure Support (AVAPS) and Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T), in patients with hypercapnic respiratory failure. It is a single-center, randomized trial involving 100 adult participants who will be assigned to one of the two ventilation methods during their hospital stay. The study will assess various clinical outcomes, including arterial blood gas measurements and length of stay in the ICU or telemetry unit, to determine which method is more beneficial for patients. The hypothesis is that AVAPS will lead to a shorter hospital stay compared to BIPAP S/T.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older diagnosed with hypercapnic respiratory failure who require noninvasive ventilation.

Not a fit: Patients who are currently intubated, have chronic tracheostomy, or require predetermined tidal volumes will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could identify a more effective noninvasive ventilation method, potentially reducing ICU stay and improving patient outcomes.

How similar studies have performed: While noninvasive ventilation is standard care, the comparative effectiveness of AVAPS versus BIPAP S/T in this specific context is not well-established, making this study a novel approach.

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

Where this trial is running

New York, New York

• Lenox Hill Hospital — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Margarita Oks, MD — Lenox Hill Hospital/Northwell Health
• Study coordinator: Sara Velichkovikj

Conditions: Hypercapnic Respiratory Failure, AVAPS, BIPAP, Hypercapnic respiratory failure, Noninvasive ventilation