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

Northwell Health

Status: Enrolling

Conditions: Hypercapnic Respiratory Failure

Treatments: Device: Average Volume-Assured Pressure Support (AVAPS); Device: Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T)

Study type: Interventional

Funder types: Other

Identifiers

NCT06047405

22-0745

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Average Volume-Assured Pressure Support (AVAPS)

Active Comparator group

Description:

Average Volume-Assured Pressure Support (AVAPS) setting on the noninvasive ventilator. The exact AVAPS setting will be titrated by the clinical team involved directly in the patient's care based on patient comfort and clinical response.

Treatment:

Device: Average Volume-Assured Pressure Support (AVAPS)

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

Active Comparator group

Description:

Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T) setting on the noninvasive ventilator. The exact BIPAP S/T setting will be titrated by the clinical team involved directly in the patient's care based on patient comfort and clinical response.

Treatment:

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