Recruiting

AVAPS vs. BIPAP S/T

Sponsor:

Northwell Health

Code:

NCT06047405

Conditions

Hypercapnic Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Average Volume-Assured Pressure Support (AVAPS)

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

Study Details

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 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.

Conditions

Hypercapnic Respiratory Failure

Study ID

NCT06047405

Start date

Oct 7, 2023

Status verified date

Oct, 2023

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 28, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Average Volume-Assured Pressure Support (AVAPS)

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.

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

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.

Interventions

Average Volume-Assured Pressure Support (AVAPS)

A setting on noninvasive ventilator that allows setting of maximum and minimum inspiratory pressure and sets a target tidal volume. The inspiratory pressure varies breath to breath to ensure pre-set tidal volume is delivered.

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

A setting on noninvasive ventilator that allows setting of inspiratory pressure, inspiratory time, expiratory pressure, and backup rate to deliver variable tidal volumes.

Primary outcome measure

  • ICU length of stay of telemetry length of stay [ Time Frame: within one week of hospital discharge (5-7 days) ]

Central Contacts and Locations

Central contacts

Sara Velichkovikj

(212)-434-4087svelichkovik@northwell.edu

Locations

Lenox Hill Hospital

Recruiting

New York, New York, United States, 10075

Contacts

Sara Velichkovikj

212-434-4087svelichkovik@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Oct 31, 2023

Last verified

Oct, 2023

Keywords

  • AVAPS
  • BIPAP
  • Hypercapnic respiratory failure
  • Noninvasive ventilation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2023-10-31.