Acute Hypoxemic Respiratory FailureNCT05675345
Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure
A study testing HFNC only, HFNC + CNEP10 and HFNC + CNEP20 in people with Acute Hypoxemic Respiratory Failure, run by NYU Langone Health at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- What is being tested?
- HFNC only, HFNC + CNEP10 and HFNC + CNEP20
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Feb 2024to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
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- Abdominal wound or surgery, symptomatic abdominal aortic aneurysm, or other unstable or high-risk intra-abdominal pathology
- Pregnancy
- Agitated delirium
- Body weight > 180 kg
- Burned skin or draining wounds under the planed cuirass area
- Indwelling tube/drain entry sites within the planned cuirass seat path
- Prior intubation during hospital stay
- Cardiogenic pulmonary edema
- Exacerbation of asthma or COPD
- Chronic lung disease, including:
- Interstitial lung disease
- Cystic fibrosis
- Lung mass, lung cancer, or metastasis to the lung
- Lung transplant recipient
- Any disease that requires home oxygen
- Glasgow coma score < 15
- Chest tube, pneumothorax, or pneumomediastinum
- Hemodynamic instability, defined as any of:
- Heart rate < 50 beats/minute
- Mean arterial pressure < 55 mmHg
- Norepinephrine-equivalent vasopressor requirement > 0.1mcg/kg/min
- Implantable electrical device (e.g. pacemaker, defibrillator, neurostimulator)
- Unreliable pulse-oximetry tracing
- Imminent intubation
- Anticipated lack of patient availability to complete study procedures (e.g. due to planned clinical procedure such as CT scan or dialysis during potential time of study)
- Attending physician refusal
- Lack of capacity for direct consent
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 3 recruiting
- Recruiting
NYU Langone Health - Brooklyn Hospital
Brooklyn, New York, 11220
- Recruiting
Bellevue Hospital
New York, New York, 10016
- Recruiting
NYU Langone Health - NYU Tisch-Kimmel Hospital
New York, New York, 10016
- Completed
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure: A Pilot Crossover Trial
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).
Read the detailed description
This study is a prospective randomized cross-over trial. Eligible, consenting participants will undergo 4 strategies of respiratory support: high-flow nasal cannula (HFNC) only, HFNC + continuous negative external pressure (CNEP) of 10 cmH2O, HFNC + CNEP of 20 cmH2O, HFNC + CNEP of 30 cmH2O. Throughout the study period, HFNC will be managed at a constant flow rate with fraction of inspired oxygen (FiO2) titrated to achieve goal oxygen saturation (SpO2) of 90-97%, measured via continuous pulse-oximetry. Each of the 4 strategies will be performed for 45 minutes per strategy, interspersed with a 15-minute washout period of HFNC only. Participants will be randomized to the sequence of strategies for respiratory support.
A summary of the sequence of trial procedures is as follows:
- Perform baseline measures.
- Wait 5-10 minutes for recovery.
- Initiate first random treatment assignment for up to 45 minutes.
- HFNC-only washout for 15 minutes
- Initiate second random treatment assignment for up to 45 minutes.
- HFNC-only washout for 15 minutes
- Initiate third random treatment assignment for up to 45 minutes.
- HFNC-only washout for 15 minutes
- Initiate fourth random treatment assignment for up to 45 minutes.
- Return to usual care (HFNC only)
If a participant does not tolerate a given level of CNEP, the patient will be returned to HFNC for 5 minutes and then given the option to attempt that CNEP level again. If the patient declines reattempt or does not tolerate that CNEP level on reattempt, the HFNC-only washout will be instituted for 15 minutes before proceeding to the next protocol step.
- Conditions
- Acute Hypoxemic Respiratory Failure
- Being tested
- HFNC only, HFNC + CNEP10, HFNC + CNEP20, HFNC + CNEP30
- Keywords
- acute respiratory distress syndrome, noninvasive ventilation, mechanical ventilation, oxygen inhalation therapy, atelectasis, high-flow nasal cannula
- Medical subject headings
- Respiratory Insufficiency, Respiratory Distress Syndrome, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNC onlyDevice
HFNC for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
HFNC + CNEP10Device
HFNC with CNEP of 10 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
HFNC + CNEP20Device
HFNC with CNEP of 20 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
HFNC + CNEP30Device
HFNC with CNEP of 30 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
| Study group | Role | What they receive |
|---|---|---|
| HFNC only | Active comparator | Not described Receives: Device: HFNC only |
| HFNC + CNEP10 | Experimental | Not described Receives: Device: HFNC + CNEP10 |
| HFNC + CNEP20 | Experimental | Not described Receives: Device: HFNC + CNEP20 |
| HFNC + CNEP30 | Experimental | Not described Receives: Device: HFNC + CNEP30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of each treatment period, up to 45 minutes
Secondary outcomes (13)
Change from baseline in Respiratory Rate
The change in Respiratory Rate within each participant as measured at baseline and at the end of each treatment assignment period. The average Respiratory Rate over the last five minutes of the treatment period will be used.
Measured: At the end of each treatment period, up to 45 minutes
Change from baseline in ROX Index
The change in ROX index within each participant as measured at baseline and at the end of each treatment assignment period. ROX index is calculated as SpO2/FiO2 divided by the Respiratory Rate. The average ROX index over the last five minutes of the treatment period will be used.
Measured: At the end of each treatment period, up to 45 minutes
Change from baseline in Transcutaneous Carbon Dioxide (CO2)
The change in Transcutaneous Carbon Dioxide within each participant as measured at baseline and at the end of each treatment assignment period. The average Transcutaneous Carbon Dioxide over the last five minutes of the treatment period will be used.
Measured: At the end of each treatment period, up to 45 minutes
Change from baseline in Heart Rate
The change in Heart Rate within each participant as measured at baseline and at the end of each treatment assignment period. The average Heart Rate over the last five minutes of the treatment period will be used.
Measured: At the end of each treatment period, up to 45 minutes
Change from baseline in Blood Pressure
The change in Blood Pressure within each participant as measured at baseline and at the end of each treatment assignment period. The average Blood Pressure over the last five minutes of the treatment period will be used.
Measured: At the end of each treatment period, up to 45 minutes
Change from baseline in Breathing Discomfort
The change in Breathing Discomfort within each participant as measured at baseline and at the end of each treatment assignment period. Breathing Discomfort will be measured with component A1 of the Multidimensional Dyspnea Profile.
Measured: At the end of each treatment period, up to 45 minutes
Change from baseline in Lightheadedness
The change in Lightheadedness within each participant as measured at baseline and at the end of each treatment assignment period. Lightheadedness will be measured with an ordinal scale ranging from 0 to 10.
Measured: At the end of each treatment period, up to 45 minutes
Change from baseline in Nausea
The change in Nausea within each participant as measured at baseline and at the end of each treatment assignment period. Nausea will be measured with an ordinal scale ranging from 0 to 10.
Measured: At the end of each treatment period, up to 45 minutes
Change from baseline in Skin Discomfort
The change in patient-reported Skin Discomfort as measured at baseline and at the end of each treatment assignment period. Skin Discomfort will be measured with an ordinal scale ranging from 0 to 10.
Measured: At the end of each treatment period, up to 45 minutes
Change from baseline in Skin Erythema
The change in Skin Erythema within each participant as measured at baseline and at the end of each treatment assignment period. Skin erythema will be measured by investigator visual assessment using a five-point scale.
Measured: At the end of each treatment period, up to 45 minutes
Tolerance of intervention period
Patient able to complete the entire treatment period of intervention without early discontinuation for intolerance
Measured: For the duration of each treatment period, up to 45 minutes
Proportion of time within 3 cm H2O of target CNEP level
Ability to reach and maintain the target CNEP level, defined as CNEP within ± 3 cm H2O of the prescribed value
Measured: For the duration of each treatment period, up to 45 minutes
Proportion of time within 5 cm H2O of target CNEP level
Ability to reach and maintain the target CNEP level, defined as CNEP within ± 5 cm H2O of the prescribed value
Measured: For the duration of each treatment period, up to 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start28 Feb 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy Beitler, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675345
- Sponsor's protocol ID
- 26-00257
- Status last verified
- Sep 2026
- First submitted
- 29 Dec 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No