Facial Mask Tightness: A Comparative Study (EMAF)

University of Limoges (UL)

Status: Completed

Conditions: Anesthesia

Treatments: Other: standard mask; Device: QuadraLite masks

Study type: Interventional

Funder types: Other

Identifiers

NCT02778984

I15035

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

standard face masks

Active Comparator group

Description:

The standard mask is used in usual care

Treatment:

Other: standard mask

QuadraLite face masks

Experimental group

Description:

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).

Treatment:

Device: QuadraLite masks