NCT05675345

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

Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure: A Pilot Crossover Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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: 1. Perform baseline measures. 2. Wait 5-10 minutes for recovery. 3. Initiate first random treatment assignment for up to 45 minutes. 4. HFNC-only washout for 15 minutes 5. Initiate second random treatment assignment for up to 45 minutes. 6. HFNC-only washout for 15 minutes 7. Initiate third random treatment assignment for up to 45 minutes. 8. HFNC-only washout for 15 minutes 9. Initiate fourth random treatment assignment for up to 45 minutes. 10. 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

Interventions

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

Timeline

• Start date: 2024-02-28
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-01-09
• Last updated: 2024-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study