Facial Mask Tightness: A Comparative Study

NCT ID: NCT02778984

Last Updated: 2019-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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standard face masks

The standard mask is used in usual care

Group Type ACTIVE_COMPARATOR

standard mask

Intervention Type OTHER

QuadraLite face 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).

Group Type EXPERIMENTAL

QuadraLite masks

Intervention Type DEVICE

The intervention is identical in the two group

Interventions

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QuadraLite masks

The intervention is identical in the two group

Intervention Type DEVICE

standard mask

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Limoges Hospital

Limoges, , France

Site Status

Countries

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France

Other Identifiers

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I15035

Identifier Type: -

Identifier Source: org_study_id

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