Clinical trial NCT06047405: NIV for Hypercapnic Respiratory Failure: AVAPS vs S/T BIPAP
Official title: NIV for Hypercapnic Respiratory Failure: AVAPS vs S/T BIPAP
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypercapnic Respiratory Failure
Keywords: AVAPS
BIPAP
Hypercapnic respiratory failure
Noninvasive ventilation
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients from medical ICU or telemetry units will be randomized to one of the following arms:

Arm 1: AVAPS mode Arm 2: BIPAP S/T mode
Primary purpose: TREATMENT

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.

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.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

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

Primary outcomes:
measure: ICU length of stay of telemetry length of stay
timeFrame: within one week of hospital discharge (5-7 days)
Secondary outcomes:
measure: Difference in PaCO2 value with NIV
timeFrame: within 24-48 hours after noninvasive ventilation
measure: Time to normalization of pH
timeFrame: at the time of hospital discharge (an average of 5-7 days)
measure: Normalization of pH
timeFrame: at the time of hospital discharge (an average of 5-7 days)
measure: Days on NIV
timeFrame: within one week of hospital discharge (5-7 days)
measure: Need for intubation
timeFrame: within one week of hospital discharge (5-7 days)
measure: Need for ICU stay
timeFrame: within one week of hospital discharge (5-7 days)
measure: Subgroup analysis (logistic regression or p-value) comparing outcomes 1- ICU or telemetry length of stay based on the underlying cause of hypercapnic respiratory failure
timeFrame: through study completion, an average of 1 year
measure: Subgroup analysis (logistic regression or p-value) comparing outcome 2- difference in paCO2 reported as difference between groups (with p-value and/or standard deviation)
timeFrame: through study completion, an average of 1 year
measure: Subgroup analysis (logistic regression or p-value) comparing outcome 4- time to normalization of pH reported as difference between groups (with p-value and/or standard deviation)
timeFrame: through study completion, an average of 1 year
measure: Subgroup analysis (logistic regression or p-value) comparing outcome 5- days on NIV reported as difference between groups (with p-value and/or standard deviation)
timeFrame: through study completion, an average of 1 year
measure: Subgroup analysis (logistic regression or p-value) comparing outcome 6- need for intubation reported as difference between groups (with p-value and/or standard deviation)
timeFrame: through study completion, an average of 1 year
measure: Subgroup analysis (logistic regression or p-value) comparing outcome 7- need for ICU stay reported as difference between groups (with p-value and/or standard deviation)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
Study officials:
affiliation: Lenox Hill Hospital/Northwell Health
name: Margarita Oks, MD
role: PRINCIPAL_INVESTIGATOR
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