NCT02778984

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 11, 2019

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

May 13, 2016

Last Update Submit

January 10, 2019

Conditions

Anesthesia

Keywords

Anesthesiafacial mask

Outcome Measures

Primary Outcomes (1)

  • significant leakage (ie greater than 20% of the current volume) between QuadraLite® mask and facial mask

    10 minutes

Study Arms (2)

standard face masks

ACTIVE COMPARATOR

The standard mask is used in usual care

Other: standard mask

QuadraLite face masks

EXPERIMENTAL

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).

Device: QuadraLite masks

Interventions

QuadraLite masksDEVICE

The intervention is identical in the two group

QuadraLite face masks
standard maskOTHER
standard face masks

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • edentulous patients
  • age \> 55 years

You may not qualify if:

  • pregnancy or breast-feeding, patients on tutelage or guardianship
  • patient unable to understand the protocol
  • anesthesia in emergency or with full stomach

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Limoges Hospital

Limoges, 87 042, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2016

First Posted

May 20, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2018

Study Completion

December 1, 2018

Last Updated

January 11, 2019

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)