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

Last updated: October 27, 2023
Sponsor: Northwell Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Treatment

Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T)

Average Volume-Assured Pressure Support (AVAPS)

Clinical Study ID

NCT06047405
22-0745
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  1. Provision of signed and dated informed consent form directly by the patient; consentcan also be obtained via a legal patient representative/health care proxy/surrogate
  2. Stated willingness to comply with all study procedures and availability for theduration 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 thetreatment of hypercarbic respiratory failure

Exclusion

Exclusion Criteria:

  1. Patients who require ventilation at predetermined tidal volumes
  2. Patients who require rapid and frequent IPAP adjustments to maintain a consistenttidal 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

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T)
Phase:
Study Start date:
October 07, 2023
Estimated Completion Date:
September 01, 2026

Study Description

  1. Overall Study Design and Plan

This is a single center, randomized trial that will include a total of 100 adult subjects aged 18 or older with hypercapnic respiratory failure of all etiologies (i.e. "all comers"). The investigators will randomize patients in a single-blinded (patient blinded) fashion to BIPAP S/T or AVAPS during the duration of their hospitalization. The investigators will assess ABG at baseline, 1 hour after initial placement on BIPAP S/T or AVAPS, and between hours 24-48 of use. The investigators will record the pre-NIV pH and PaCO2, post-NIV pH and PaCO2, length of hospital stay in the medical ICU or telemetry unit, days on NIV, need for intubation (if occurred), transition to medical ICU care in patients who were initially admitted to telemetry, and in-hospital mortality. All collected laboratory data are already done as part of usual care for all patients placed on NIV when a patient is on the telemetry unit or medical ICU. The groups will undergo stratified randomization based on whether they are initially admitted to medical ICU or medical telemetry. Patients from medical ICU or telemetry units will be randomized to one of the following arms:

Arm 1: AVAPS mode Arm 2 2: BIPAP S/T mode

Connect with a study center

  • Lenox Hill Hospital

    New York, New York 10075
    United States

    Active - Recruiting

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