Clinical trial NCT04102735: Under the Nose Face Mask to Prevent Facial Pressure Ulcers During NIV for Acute Hypercapnic Respiratory Failure (AHRF)
Official title: UNDER the Nose vs. Over the Nose Face Mask to Prevent Facial PRESSURE Ulcers During Face Mask-noninvasive Ventilation for Acute Hypercapnic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Hypercapnic Respiratory Failure
Keywords: facial pressure ulcers
noninvasive ventilation
acute hypercapnic respiratory failure
Lead sponsor: Centre Hospitalier Arras
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: 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.
timeFrame: 3 days after NIV initiation
Secondary outcomes:
measure: Change of the delay for facial pressure ulcers to appear in the experimental arm, compared to the control arm
timeFrame: 7 days after NIV initiation
measure: Change of the severity of facial pressure ulcers in the experimental arm, compared to the control arm
timeFrame: 7 days after NIV initiation
measure: Change of the patient comfort in the experimental arm, compared to the control arm
timeFrame: 24 hours after NIV initiation
measure: Change of the incidence of mask changes related to interface intolerance in the experimental arm, compared to the control arm
timeFrame: 7 days after NIV initiation
measure: Change of the incidence of NIV failure in the experimental arm, compared to the control arm
timeFrame: 7 days after NIV initiation
Other outcomes:
Locations:
city: Arras
country: France
facility: Centre Hospitalier Arras
city: Lens
country: France
facility: Centre Hospitalier Lens
Study officials:
affiliation: Centre Hospitalier Arras
name: Malcolm LEMYZE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.