NCT02906267

Brief Summary

This study is designed to evaluate the occurrence of gastric insufflation and the critical volume of the stomach after three different modes of positive pressure ventilation during induction (Manual-controlled, volume-controlled and pressure-controlled ventilation)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

September 5, 2016

Last Update Submit

July 13, 2017

Conditions

Positive-Pressure RespirationRespiratory Aspiration of Gastric Content

Outcome Measures

Primary Outcomes (1)

  • Gastric volume before and after positive pressure ventilation

    15 minutes

Secondary Outcomes (1)

  • Ultrasonographic detection of gastric insufflation during ventilation

    15 minutes

Study Arms (3)

Manual-controlled

OTHER

Patient in the manual ventilation group will receive facemask ventilation to get a tidal volume of 8-10ml/kg with a respiratory rate of 15/min. The pop-off valve will be set to 20 cm H2O.

Other: Diagnostic ultrasonography of gastric volume

Volume-controlled

OTHER

mechanical breath will be delivered by a Primus ventilator (Dräger, Lubeck, Germany) at a frequency of 15 breath/min. Tidal volume will be set to 8-10 ml/min.

Other: Diagnostic ultrasonography of gastric volume

Pressure-controlled

OTHER

mechanical breath will be delivered by a Primus ventilator (Dräger, Lubeck, Germany) at a frequency of 15 breath/min. Pressure will be adjusted to obtain a tidal volume of 8-10 ml/min.

Other: Diagnostic ultrasonography of gastric volume

Interventions

Diagnostic ultrasonography of gastric volumeOTHER

Ultrasonic measurement of gastric insufflation during positive pressure ventilation (secondary endpoint) and final gastric volume after positive pressure ventilation (primary endpoint)

Manual-controlledPressure-controlledVolume-controlled

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA status I and II

You may not qualify if:

  • Pregnant woman Obese patient (BMI\>30kgm-2) oropharyngeal or facial anomalies anticipated difficult mask ventilation upper respiratory tract infection history of gastric surgery patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, France

RECRUITING

Study Officials

  • Pierre LAFERE, MD,PhD

    CHRU de Brest

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre LAFERE, MD, PhD

CONTACT

0033298347658pierre.lafere@chu-brest.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Docteur Pierre Lafère

Study Record Dates

First Submitted

September 5, 2016

First Posted

September 20, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 17, 2017

Record last verified: 2017-07

Locations

FR(1)