Facial Mask Tightness: A Comparative Study
Not Applicable
Completed
- Conditions
- Anesthesia
- Interventions
- Other: standard maskDevice: QuadraLite masks
- Registration Number
- NCT02778984
- Lead Sponsor
- University Hospital, Limoges
- Brief Summary
A correct preoxygenation can be obtained after a 3min delay of calm ventilation through a tight mask thereafter mask is used to make the patient breathing before intubation. Most tight masks are actually sold but they have never been compared in studies. The aim of this study is to compare air leaks with standard facial mask and QuadraLite masks during preoxygenation and induction of anesthesia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- edentulous patients
- age > 55 years
Exclusion Criteria
- pregnancy or breast-feeding, patients on tutelage or guardianship
- patient unable to understand the protocol
- anesthesia in emergency or with full stomach
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard face masks standard mask The standard mask is used in usual care QuadraLite face masks QuadraLite masks This study will compare tightness of 2 face masks during preoxygenation and after induction of anesthesia with propofol, sufentanil and rocuronium. During preoxygenation, a 10 l.min-1 fresh gas flow and 8 cm H2O PEEP will be applied. After induction of anesthesia, patients will receive pressure-controlled ventilation (fresh gaz flow 3 L.min-1, pressure set to obtain a 7 ml.kg-1 ideal body weight, 10 cpm, peep 5 cm H2O).
- Primary Outcome Measures
Name Time Method significant leakage (ie greater than 20% of the current volume) between QuadraLite® mask and facial mask 10 minutes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Limoges Hospital
🇫🇷Limoges, France