UNDER the Nose vs. Over the Nose Face Mask to Prevent Facial PRESSURE Ulcers During Face Mask-noninvasive Ventilation for Acute Hypercapnic Respiratory Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Hypercapnic Respiratory Failure
- Sponsor
- Centre Hospitalier Arras
- Enrollment
- 108
- Locations
- 2
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.
Time Frame: 3 days after NIV initiation
The primary endpoint is the development of a facial pressure ulcer within the first 3 days after NIV initiation
Secondary Outcomes
- 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 delay for facial pressure ulcers to appear in the experimental arm, compared to the control arm(7 days 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)