Who is sponsoring NCT04102735?

NCT04102735 is sponsored by Centre Hospitalier Arras.

What drugs are being tested in NCT04102735?

Interventions in NCT04102735: Under-the-nose facemask, Over-the-nose facemask.

What condition does NCT04102735 study?

NCT04102735 studies Acute Hypercapnic Respiratory Failure.

Is NCT04102735 still recruiting?

NCT04102735 is currently completed. Last updated 15 March 2022.

Last reviewed 2022-03-15 · How we verify

NCT04102735: UNDER PRESSURE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 15 March 2022

What this trial tests

NA trial testing Under-the-nose facemask in Acute Hypercapnic Respiratory Failure in 108 participants. Completed in 3 October 2021.

Timeline

21 November 2018

Primary endpoint
3 October 2021

3 October 2021

Quick facts

Lead sponsor	Centre Hospitalier Arras
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	108
Start date	21 November 2018
Primary completion	3 October 2021
Estimated completion	3 October 2021
Sites	2 locations across France

Drugs / interventions tested

Under-the-nose facemask
Over-the-nose facemask

Conditions studied

Acute Hypercapnic Respiratory Failure — all drugs for Acute Hypercapnic Respiratory Failure →

Sponsor

Centre Hospitalier Arras

Who can join

18 and older, any sex, with Acute Hypercapnic Respiratory Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Noninvasive ventilation (NIV) is essential to treat acute hypercapnic respiratory failure. However, facial pressure ulcers appearing during facemask-delivered noninvasive ventilation are a source of NIV failure by interface intolerance. A Philips facemask (model : AF541 SE Oro-Nasal mask) has the particularity to display two options for its positioning : a usually used "over-the-nose" positioning or an "under-the-nose" positioning that is supposed to reduce the incidence of facial pressure ulcers while keeping in the same time the qualities of a standard facemask. The goal of this controlled randomized trial is to test the hypothesis that the "under-the-nose" positioning actually reduces the incidence of facial pressure ulcers, compared to the usually used "over-the-nose" positioning. Results of this trial should lead to the proposition of a new interface strategy to prevent facial pressure ulcers and therefore to improve the tolerance of NIV via the use of facemasks displaying an "under-the-nose" positioning.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Acute Hypercapnic Respiratory Failure

Currently open trials in the same condition.

NCT06374589 — Closed-Loop O2 Use During High Flow Oxygen Treatment of Critical Care Adult Patients (CLOUDHFOT) · NA · recruiting
NCT05011877 — The Simplify Project · recruiting
NCT03033251 — High Flow Nasal Cannula Versus Non-Invasive Ventilation in Exacerbations of Chronic Obstructive Pulmonary Disease · NA · recruiting

Other Centre Hospitalier Arras trials

Trials by the same sponsor.

NCT06562725 — Ventilator Settings for Bronchoscopy During Mechanical Ventilation: a Randomized Controlled Study · NA · completed
NCT05358067 — Predictability of the Clinical Global Impression Scale (CGI) in Post Immediate in Psychotraumatic Impact · recruiting
NCT04588610 — Severe Obesity and Eating Habits (OSCAR) · completed
NCT04391686 — Resting Energy Expenditure of the COronaVirus (COVID19) Patient in Reanimation Context · completed
NCT03610074 — Relieve the Patient's Thirst, Refresh the Mouth First (ICU-MIC) · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04102735 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Arras
Last refreshed: 15 March 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04102735.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing