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

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05675345
Status
Recruiting
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Conditions

  • Acute Hypoxemic Respiratory Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HFNC only — DEVICE
    HFNC for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
  • HFNC + CNEP10 — DEVICE
    HFNC with CNEP of 10 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
  • HFNC + CNEP20 — DEVICE
    HFNC with CNEP of 20 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
  • HFNC + CNEP30 — DEVICE
    HFNC with CNEP of 30 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%

Study Details

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).

Key Dates

Start date
Feb 28, 2024
Status verified
Feb 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: HFNC only
  • Experimental: HFNC + CNEP10
  • Experimental: HFNC + CNEP20
  • Experimental: HFNC + CNEP30

Primary Outcome Measure

Change from baseline in SpO2/FiO2 [ Time Frame: At the end of each treatment period, up to 45 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Jeremy Beitler, MD, MPH
[email protected]
212-305-0334

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By research site
Columbia University Irving Medical Center· New York, NY

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