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

NCT ID: NCT04102735

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-21
• Study Completion Date: 2021-10-03

Brief Summary

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.

Conditions

Acute Hypercapnic Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Over-the-nose facemask

The AF541 oro-nasal mask is used with the over-the-nose mask cushion.

Group Type: ACTIVE_COMPARATOR

Over-the-nose facemask

Intervention Type: DEVICE

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.

Under-the-nose facemask

The AF541 oro-nasal mask is used with the under-the-nose mask cushion.

Group Type: EXPERIMENTAL

Under-the-nose facemask

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Acute hypercapnic respiratory failure
• Initiation of NIV
• Estimated cumulative time of NIV upper than 12 hours for the first 48 hours of hospitalization

Exclusion Criteria

• Contraindication for NIV (respiratory arrest, impossibility to fit the mask)
• Intubated patient
• Patient with a tracheostomy
• Post-extubation respiratory failure
• Patient exhibiting facial ulcers or skin lesions located at the insertion points of the mask before its hospitalization
• Person declining NIV
• Pregnancy
• Dying person

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Arras

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malcolm LEMYZE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Arras

Locations

Centre Hospitalier Arras

Arras, , France

Centre Hospitalier Lens

Lens, , France

Countries

France

References

Edsberg LE, Black JM, Goldberg M, McNichol L, Moore L, Sieggreen M. Revised National Pressure Ulcer Advisory Panel Pressure Injury Staging System: Revised Pressure Injury Staging System. J Wound Ostomy Continence Nurs. 2016 Nov/Dec;43(6):585-597. doi: 10.1097/WON.0000000000000281.

Reference Type: BACKGROUND

PMID: 27749790 (View on PubMed)

Lemyze M, Mallat J, Nigeon O, Barrailler S, Pepy F, Gasan G, Vangrunderbeeck N, Grosset P, Tronchon L, Thevenin D. Rescue therapy by switching to total face mask after failure of face mask-delivered noninvasive ventilation in do-not-intubate patients in acute respiratory failure. Crit Care Med. 2013 Feb;41(2):481-8. doi: 10.1097/CCM.0b013e31826ab4af.

Reference Type: BACKGROUND

PMID: 23263582 (View on PubMed)

Gregoretti C, Confalonieri M, Navalesi P, Squadrone V, Frigerio P, Beltrame F, Carbone G, Conti G, Gamna F, Nava S, Calderini E, Skrobik Y, Antonelli M. Evaluation of patient skin breakdown and comfort with a new face mask for non-invasive ventilation: a multi-center study. Intensive Care Med. 2002 Mar;28(3):278-84. doi: 10.1007/s00134-002-1208-7. Epub 2002 Feb 6.

Reference Type: BACKGROUND

PMID: 11904656 (View on PubMed)

Lemyze M, Mallat J, Vangrunderbeek N, Granier M. Under-The-Nose Versus Over-The-Nose Face Mask to Prevent Facial Pressure Sores During Face Mask-Delivered Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure: A Randomized Controlled Trial. Crit Care Med. 2023 Sep 1;51(9):1177-1184. doi: 10.1097/CCM.0000000000005902. Epub 2023 May 11.

Reference Type: DERIVED

PMID: 37166242 (View on PubMed)

Other Identifiers

2017-02

Identifier Type: -

Identifier Source: org_study_id