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Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure

StatusRecruiting
PhaseNot applicable
Started2024-02-28
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Dec 31, 2026 → Jun 30, 2027
See other at-risk trials from NYU Langone Health

Amendment history

2026-10-02
Sponsor changed: Columbia University → NYU Langone Health-1 characters
WasColumbia University
NowNYU Langone Health
Trial sites expanded: 1 → 4 locations
Primary completion pushed: 2026-12-31 → 2027-06-30
Completion pushed: 2026-12-31 → 2027-06-30
2024-02-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v8
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-12-01→confirmed 2024-02-28
Study sitesdetails revised at 1 of 1 site
2024-02-28
Study Status v7
Primary completion date2025-12-31→2026-12-31
Completion date2025-12-31→2026-12-31
Start date2024-03-01→2024-12-01
2023-12-14
Study Status, Study Description, Arms and Interventions v6
Study descriptionrevised
[...] (FiO2) titrated to achieve goal oxygen saturation (SpO2) of 9290-9697%, measured via continuous pulse-oximetry. Each of the 4 str [...]
2023-10-23
Study Status, Study Description, Arms and Interventions, Outcome Measures v5
Primary completion date2025-07-31→2025-12-31
Completion date2025-07-31→2025-12-31
Start date2023-11-15→2024-03-01
Secondary endpoints14 to 13 entries
Change from baseline in Anxiety
Study description+20 characters
[...] se-oximetry. Each of the 4 strategies will be performed for 145 hourminutes per strategy, interspersed with a 2015-minute washout period of HFNC only. Participants will be ra [...] overy. Initiate first random treatment assignment for up to 145 hourminutes. HFNC-only washout for 2015 minutes Initiate second random treatment assignment for up to 145 hourminutes. HFNC-only washout for 2015 minutes Initiate third random treatment assignment for up to 145 hourminutes. HFNC-only washout for 2015 minutes Initiate fourth random treatment assignment for up to 145 hourminutes. Return to usual care (HFNC only) [...] [...]
Show 4 earlier versions
2023-07-03
Study Identification, Study Status, Outcome Measures v4
Primary completion date2024-12-31→2025-07-31
Completion date2025-04-01→2025-07-31
Secondary endpoints15 to 14 entries
ChangeTolerance fromof baselineintervention inperiod Proportion Minuteof Ventilationtime within 3 cm H2O of target CNEP level ChangeProportion fromof baselinetime inwithin Tidal5 Volume Changecm fromH2O baselineof intarget AnteroposteriorCNEP Ventilation Ratio Change from baseline in End-Expiratory Lung Volumelevel
2023-06-25
Study Status, Eligibility v3
Eligibility criteria+135 characters
Inclusion Criteria: Age 18 years or older Acute hypoxemic respiratory failure Non-cardiogenic airspace [...] 96 hours (4 days) FiO2 ≥ 40% SpO2 ≥ 92% Exclusion Criteria: Age < 18 years Do-not-intubate order Anatomical factor predisposing to poor [...] a score < 15 Chest tube, pneumothorax, or pneumomediastinum Hemodynamic instability (mean arterial pressure < 55 mmHg or norepinephrine-equivalent vasopressor requirement > 0.1mcg/kg/min) Implantable electrical device (e.g. pacemaker, defibrillator [...]
2023-05-11
Study Status v2
Primary completion date2024-08-31→2024-12-31
Completion date2024-12-30→2025-04-01
Start date2023-05-15→2023-11-15
2023-03-01
Study Status v1
Start date2023-03-15→2023-05-15
2022-12-29
Original filing
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 Details
NCT Number NCT05675345
Lead Sponsor NYU Langone Health
Conditions Acute Hypoxemic Respiratory Failure
Enrollment 20 participants
Start Date 2024-02-28
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-10-01