Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure
1 other identifier
interventional
20
1 country
1
Brief Summary
This study is being conducted to evaluate if wearing a non-invasive breathing support device over the chest/abdomen improves markers of breathing in patients with lung injury requiring high-flow oxygen. The breathing support device consists of a plastic shell that sits over the chest and abdomen and connects to a vacuum that helps the chest expand with breathing. This breathing support is known as continuous negative external pressure (CNEP). Study findings will help determine if this breathing support device might be useful for patients with acute hypoxemic respiratory failure (AHRF).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2022
CompletedFirst Posted
Study publicly available on registry
January 9, 2023
CompletedStudy Start
First participant enrolled
February 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
March 4, 2024
February 1, 2024
2.8 years
December 29, 2022
February 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in SpO2/FiO2
The change in SpO2/FiO2 within each participant as measured at baseline and at the end of each treatment assignment period. The average SpO2/FiO2 over the last five minutes of the treatment period will be used.
At the end of each treatment period, up to 45 minutes
Secondary Outcomes (13)
Change from baseline in Respiratory Rate
At the end of each treatment period, up to 45 minutes
Change from baseline in ROX Index
At the end of each treatment period, up to 45 minutes
Change from baseline in Transcutaneous Carbon Dioxide (CO2)
At the end of each treatment period, up to 45 minutes
Change from baseline in Heart Rate
At the end of each treatment period, up to 45 minutes
Change from baseline in Blood Pressure
At the end of each treatment period, up to 45 minutes
- +8 more secondary outcomes
Other Outcomes (5)
Change from baseline in other components of the Multidimensional Dyspnea Profile
At end of study
Change from baseline in Tidal Volume
At the end of each treatment period, up to 45 minutes
Change from baseline in End-Expiratory Lung Volume
At the end of each treatment period, up to 45 minutes
- +2 more other outcomes
Study Arms (4)
HFNC only
ACTIVE COMPARATORHFNC + CNEP10
EXPERIMENTALHFNC + CNEP20
EXPERIMENTALHFNC + CNEP30
EXPERIMENTALInterventions
HFNC with CNEP of 10 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
HFNC with CNEP of 20 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
HFNC with CNEP of 30 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
Eligibility Criteria
You may qualify if:
- Age 18 years or older
- Acute hypoxemic respiratory failure
- Non-cardiogenic airspace opacities on chest radiograph or computed tomography (CT) scan
- High-flow nasal cannula (flow ≥ 30 LPM) initiated within last 96 hours (4 days)
- FiO2 ≥ 40%
- SpO2 ≥ 92%
You may not qualify if:
- Do-not-intubate order
- Anatomical factor predisposing to poor fit of cuirass (e.g. severe kyphosis or scoliosis)
- Use of cuirass precluded, e.g. due to:
- Clinically prescribed prone positioning
- Tense ascites
- Severe abdominal pain
- Abdominal wound or surgery
- Pregnancy
- Agitated delirium
- Prior intubation during hospital stay
- Cardiogenic pulmonary edema
- Exacerbation of asthma or COPD
- Chronic lung disease, including:
- Interstitial lung disease
- Cystic fibrosis
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Irving Medical Center
New York, New York, 10032, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremy Beitler, MD, MPH
Columbia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
December 29, 2022
First Posted
January 9, 2023
Study Start
February 28, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 4, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share