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

October 27, 2023 updated by: Northwell Health
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10075
        • Recruiting
        • Lenox Hill Hospital
        • Sub-Investigator:
          • Zein Kattih, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within one week of hospital discharge (5-7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
within 24-48 hours after noninvasive ventilation
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)
at the time of hospital discharge (an average of 5-7 days)
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)
at the time of hospital discharge (an average of 5-7 days)
Days on NIV
Time Frame: within one week of hospital discharge (5-7 days)
Days on noninvasive ventilation
within one week of hospital discharge (5-7 days)
Need for intubation
Time Frame: within one week of hospital discharge (5-7 days)
Need for intubation
within one week of hospital discharge (5-7 days)
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)
within one week of hospital discharge (5-7 days)
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Margarita Oks, MD, Lenox Hill Hospital/Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2023

Primary Completion (Estimated)

September 28, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 10, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-0745

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only researchers on involved in conducting the study will have access to the information collected in the study.

9.3 Data Handling and Record Keeping 9.3.1 Data Collection and Management All information accessed from the medical record will be de-identified. All data will be stored on an encrypted secure server, REDCap.

9.3.2 Confidentiality and Privacy Privacy will be protected as data will be collected within the Northwell Redcap data portal. All data will be de-identified prior to entry into REDCap. All communication between subjects and researchers will be conducted in a private setting.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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