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

Primary Purpose

Hypercapnic Respiratory Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Average Volume-Assured Pressure Support (AVAPS)
Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T)
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercapnic Respiratory Failure focused on measuring AVAPS, BIPAP, Hypercapnic respiratory failure, Noninvasive ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lenox Hill Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Average Volume-Assured Pressure Support (AVAPS)

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

Arm 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.

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.

Outcomes

Primary Outcome Measures

ICU length of stay of telemetry length of stay
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 Outcome Measures

Difference in PaCO2 value with NIV
Change in paCO2 on ABG (paCO2 before and after NIV use, measured as a numerical value in mmHg)
Time to normalization of pH
Time to normalization of pH (hours)
Normalization of pH
Return to normal range of pH as defined by the laboratory normal values (Binary measure)
Days on NIV
Days on noninvasive ventilation
Need for intubation
Need for intubation
Need for ICU stay
Need for ICU stay (if disposition changed from telemetry unit)
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
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.

Full Information

First Posted
August 10, 2023
Last Updated
October 2, 2023
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT06047405
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
September 28, 2025 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercapnic Respiratory Failure
Keywords
AVAPS, BIPAP, Hypercapnic respiratory failure, Noninvasive ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Average Volume-Assured Pressure Support (AVAPS)
Arm Type
Active Comparator
Arm 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.
Arm Title
Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Average Volume-Assured Pressure Support (AVAPS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T)
Intervention Description
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 Information:
Title
ICU length of stay of telemetry length of stay
Description
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.
Time Frame
within one week of hospital discharge (5-7 days)
Secondary Outcome Measure Information:
Title
Difference in PaCO2 value with NIV
Description
Change in paCO2 on ABG (paCO2 before and after NIV use, measured as a numerical value in mmHg)
Time Frame
within 24-48 hours after noninvasive ventilation
Title
Time to normalization of pH
Description
Time to normalization of pH (hours)
Time Frame
at the time of hospital discharge (an average of 5-7 days)
Title
Normalization of pH
Description
Return to normal range of pH as defined by the laboratory normal values (Binary measure)
Time Frame
at the time of hospital discharge (an average of 5-7 days)
Title
Days on NIV
Description
Days on noninvasive ventilation
Time Frame
within one week of hospital discharge (5-7 days)
Title
Need for intubation
Description
Need for intubation
Time Frame
within one week of hospital discharge (5-7 days)
Title
Need for ICU stay
Description
Need for ICU stay (if disposition changed from telemetry unit)
Time Frame
within one week of hospital discharge (5-7 days)
Title
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
Description
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.
Time Frame
through study completion, an average of 1 year
Title
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)
Description
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.
Time Frame
through study completion, an average of 1 year
Title
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)
Description
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.
Time Frame
through study completion, an average of 1 year
Title
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)
Description
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.
Time Frame
through study completion, an average of 1 year
Title
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)
Description
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.
Time Frame
through study completion, an average of 1 year
Title
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)
Description
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.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Velichkovikj
Phone
(212)-434-4087
Email
svelichkovik@northwell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarita Oks, MD
Organizational Affiliation
Lenox Hill Hospital/Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Velichkovikj
Phone
212-434-4087
Email
svelichkovik@northwell.edu
First Name & Middle Initial & Last Name & Degree
Zein Kattih, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
30317536
Citation
Briones-Claudett KH, Esquinas Rodriguez A, Briones-Claudett MH, Puga-Tejada M, Cabrera Banos MDP, Pazmino Duenas CR, Torres Herrera CI, Grunauer M. Use of noninvasive mechanical ventilation with pressure support guaranteed with average volume in de novo hypoxaemic respiratory failure. A pilot study. Anaesthesiol Intensive Ther. 2018;50(4):283-290. doi: 10.5603/AIT.a2018.0036. Epub 2018 Oct 14.
Results Reference
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NIV for Hypercapnic Respiratory Failure: AVAPS vs S/T BIPAP

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