Status:
RECRUITING
NIV for Hypercapnic Respiratory Failure: AVAPS vs S/T BIPAP
Lead Sponsor:
Northwell Health
Conditions:
Hypercapnic Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 wi...
Detailed 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....
Eligibility Criteria
Inclusion
- 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
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 or older
- Diagnosed with hypercapnic respiratory failure on admission (ABG)
- Admitted to Lenox Hill Hospital medical intensive care unit or telemetry unit
- Requiring noninvasive ventilation as determined by the treating physician for the treatment of hypercarbic respiratory failure
Exclusion
- Patients who require ventilation at predetermined tidal volumes
- Patients who require rapid and frequent IPAP adjustments to maintain a consistent tidal volume
- Age less than 18 years of age
- Currently intubated
- Chronic tracheostomy
- Pregnancy
- Hypotension
- Epistaxis (nosebleed)
- Untreated pertussis
- Acute sinusitis or Otitis media
- Patients at risk of aspirating gastric contents
- Patients with lack of spontaneous respiratory drive
- Patients with the inability to maintain a patent airway or adequately clear secretions
- Prisoners or other institutionalized individuals
Key Trial Info
Start Date :
October 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06047405
Start Date
October 7 2023
End Date
September 1 2026
Last Update
October 31 2023
Active Locations (1)
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1
Lenox Hill Hospital
New York, New York, United States, 10075