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

NCT04102735 | Completed

• 1 other identifier: 2017-02
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

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

Keywords

facial pressure ulcers; noninvasive ventilation; acute hypercapnic respiratory failure

Outcome Measures

Primary Outcomes (1)

• Change of the incidence of facial pressure ulcers in the experimental arm compared to the control arm, within the first 3 days after NIV initiation.

  The primary endpoint is the development of a facial pressure ulcer within the first 3 days after NIV initiation

  3 days after NIV initiation

Secondary Outcomes (5)

• Change of the delay for facial pressure ulcers to appear in the experimental arm, compared to the control arm

  7 days after NIV initiation

• Change of the severity of facial pressure ulcers in the experimental arm, compared to the control arm

  7 days after NIV initiation

• Change of the patient comfort in the experimental arm, compared to the control arm

  24 hours after NIV initiation

• Change of the incidence of mask changes related to interface intolerance in the experimental arm, compared to the control arm

  7 days after NIV initiation

• Change of the incidence of NIV failure in the experimental arm, compared to the control arm

  7 days after NIV initiation

Study Arms (2)

Over-the-nose facemask

ACTIVE COMPARATOR

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

Device: Over-the-nose facemask

Under-the-nose facemask

EXPERIMENTAL

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

Device: Under-the-nose facemask

Interventions

Under-the-nose facemask 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.

Under-the-nose facemask

Over-the-nose facemask 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.

Over-the-nose facemask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Arras: lead

Study Sites (2)

Centre Hospitalier Arras

Arras, France

Location

Centre Hospitalier Lens

Lens, France

Location

Related Publications (4)

• 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.

  PMID: 27749790 BACKGROUND

• 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.

  PMID: 23263582 BACKGROUND

• 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.

  PMID: 11904656 BACKGROUND

• 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.

  PMID: 37166242 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Malcolm LEMYZE, MD

  Centre Hospitalier Arras

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: September 25, 2019
• Study Start: November 21, 2018
• Primary Completion: October 3, 2021
• Study Completion: October 3, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

FR (2)