Clinical Efficacy of a Cephalic Mask for Noninvasive Ventilation During Acute Hypercapnic Respiratory Failure
- Conditions
- Acute Hypercapnic Respiratory Failure
- Registration Number
- NCT00213395
- Lead Sponsor
- University Hospital, Rouen
- Brief Summary
Noninvasive ventilation (NIV) is now a major therapeutic option to manage patients with acute hypercapnic respiratory failure (AHRF). Otherwise, patient-ventilator interfaces are determinant to get an optimal NIV efficacy in parallel with ventilatory comfort.
Facial masks during NIV are associated with deleterious consequences like gas leaks around the mask, skin breakdown (especially on the nasal bridge), claustrophobia and mask discomfort. In order to limit these side effects, a cephalic interface has been recently designed. Cephalic mask covers the whole anterior surface of the face and excessive mask fit pressure is therefore spread over a larger surface outside the nose area. However, this mask has a high volume that may interfere with NIV efficacy and may also induce claustrophobic sensations.
The aim of this study is to compare the clinical efficacy and tolerance of a cephalic mask versus a conventional oronasal mask during AHRF.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
- Acute hypercapnic respiratory failure
- Indication to noninvasive ventilation
- Requirement for endotracheal intubation
- Proven pulmonary embolism
- Present or previous history of ophthalmologic disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Arterial blood gases
- Secondary Outcome Measures
Name Time Method Respiratory frequency Severity scores Ventilatory settings Patient-ventilator adaptation Tolerance Outcome Complications
Trial Locations
- Locations (1)
Pulmonary & Intensive Care Department - Rouen University Hospital,
🇫🇷Rouen, France