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NCT Number: NCT06047405

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

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.

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Key information

Conditions

Hypercapnic Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lenox Hill Hospital

New York, 10075, United States

Location status: Recruiting

Location contact

Sara Velichkovikj

CONTACT

[email protected]

212-434-4087

Zein Kattih, MD

SUB_INVESTIGATOR

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Average Volume-Assured Pressure Support (AVAPS)

Device

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)

Device

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

Primary outcomes

  1. ICU length of stay of telemetry length of stay

    Time frame: within one week of hospital discharge (5-7 days)

    In patients admitted to the medical ICU, the primary endpoint is ICU length of stay. This will be the number of days a patient is admitted from day 1 of admission until the day of discharge. In patients admitted to medical telemetry unit, the outcome is telemetry length of stay. This will be the number of days a patient is admitted from day 1 of admission until the day of discharge.

Secondary outcomes

  1. Difference in PaCO2 value with NIV

    Time frame: within 24-48 hours after noninvasive ventilation

    Change in paCO2 on ABG (paCO2 before and after NIV use, measured as a numerical value in mmHg)

  2. Time to normalization of pH

    Time frame: at the time of hospital discharge (an average of 5-7 days)

    Time to normalization of pH (hours)

  3. Normalization of pH

    Time frame: at the time of hospital discharge (an average of 5-7 days)

    Return to normal range of pH as defined by the laboratory normal values (Binary measure)

  4. Days on NIV

    Time frame: within one week of hospital discharge (5-7 days)

    Days on noninvasive ventilation

  5. Need for intubation

    Time frame: within one week of hospital discharge (5-7 days)

    Need for intubation

  6. Need for ICU stay

    Time frame: within one week of hospital discharge (5-7 days)

    Need for ICU stay (if disposition changed from telemetry unit)

  7. 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

    Time frame: through study completion, an average of 1 year

    We will perform subgroup analysis of each cause of hypercapnic respiratory failure (such as COPD, pulmonary edema, altered mental status, etc) for these outcome- for 1. ICU or telemetry length of stay. We will use either logistic regression model or p-value to determine the difference for each subgroup. The results will be reported as difference between groups with statistical significance.

  8. 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)

    Time frame: through study completion, an average of 1 year

    We will perform subgroup analysis of each cause of hypercapnic respiratory failure (such as COPD, pulmonary edema, altered mental status, etc) for outcome 2- difference in PaCO2. We will use either logistic regression model or p-value to determine the difference for each subgroup. The results will be reported as difference between groups with statistical significance.

  9. 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)

    Time frame: through study completion, an average of 1 year

    We will perform subgroup analysis of each cause of hypercapnic respiratory failure (such as COPD, pulmonary edema, altered mental status, etc) for outcome 4- time to normalization of pH. We will use either logistic regression model or p-value to determine the difference for each subgroup. The results will be reported as difference between groups with statistical significance.

  10. 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)

    Time frame: through study completion, an average of 1 year

    We will perform subgroup analysis of each cause of hypercapnic respiratory failure (such as COPD, pulmonary edema, altered mental status, etc) for outcome 5- days on NIV. We will use either logistic regression model or p-value to determine the difference for each subgroup. The results will be reported as difference between groups with statistical significance.

  11. 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)

    Time frame: through study completion, an average of 1 year

    We will perform subgroup analysis of each cause of hypercapnic respiratory failure (such as COPD, pulmonary edema, altered mental status, etc) for outcome 6- need for intubation. We will use either logistic regression model or p-value to determine the difference for each subgroup. The results will be reported as difference between groups with statistical significance.

  12. 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)

    Time frame: through study completion, an average of 1 year

    We will perform subgroup analysis of each cause of hypercapnic respiratory failure (such as COPD, pulmonary edema, altered mental status, etc) for outcome 7- need for ICU stay. We will use either logistic regression model or p-value to determine the difference for each subgroup. The results will be reported as difference between groups with statistical significance.

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Velichkovikj

CONTACT

[email protected]

(212)-434-4087

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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