Status:
COMPLETED
Under the Nose Face Mask to Prevent Facial Pressure Ulcers During NIV for Acute Hypercapnic Respiratory Failure (AHRF)
Lead Sponsor:
Centre Hospitalier Arras
Conditions:
Acute Hypercapnic Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 N...
Eligibility Criteria
Inclusion
- Acute hypercapnic respiratory failure
- Initiation of NIV
- Estimated cumulative time of NIV upper than 12 hours for the first 48 hours of hospitalization
Exclusion
- 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
Key Trial Info
Start Date :
November 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2021
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04102735
Start Date
November 21 2018
End Date
October 3 2021
Last Update
March 15 2022
Active Locations (2)
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1
Centre Hospitalier Arras
Arras, France
2
Centre Hospitalier Lens
Lens, France