NCT04102735View on ClinicalTrials.gov

Under the Nose Face Mask to Prevent Facial Pressure Ulcers During NIV for Acute Hypercapnic Respiratory Failure (AHRF)

NACompletedINTERVENTIONAL

Enrollment

108

Participants

Timeline

Start Date

November 21, 2018

Primary Completion Date

October 3, 2021

Study Completion Date

October 3, 2021

Conditions

Acute Hypercapnic Respiratory Failure

Interventions

DEVICE

Under-the-nose facemask

Patients with acute hypercapnic respiratory failure that need noninvasive ventilation and are randomized in the experimental group will receive the AF541 facemask used with the under-the-nose cushion.

DEVICE

Over-the-nose facemask

Patients with acute hypercapnic respiratory failure that need non-invasive ventilation and are randomized in the comparator group will receive the AF541 facemask used with the over-the-nose cushion.

Trial Locations (2)

Unknown

Centre Hospitalier Arras, Arras

Centre Hospitalier Lens, Lens

All Listed Sponsors

lead

Centre Hospitalier Arras

OTHER

NCT04102735 - Under the Nose Face Mask to Prevent Facial Pressure Ulcers During NIV for Acute Hypercapnic Respiratory Failure (AHRF) | Biotech Hunter | Biotech Hunter