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NCT02906267 Clinical Trial

Ultrasonographic Comparison of Gastric Volume After Three Modes of Positive Facemask During Induction of Anaesthesia

Positive-Pressure Respiration Clinical Trial

— UGV  

Official title:
Ultrasonographic Comparison of Gastric Volume After Three Modes of Positive Facemask. A Prospective Randomized Study.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02906267
Other study ID # Ultrasonic gastric volume
Secondary ID
Status Recruiting
Phase N/A
First received September 5, 2016
Last updated July 13, 2017
Start date December 2016
Est. completion date December 2017

Study information
Verified date July 2017
Source University Hospital, Brest
Contact Pierre LAFERE, MD, PhD
Phone 0033298347658
Email pierre.lafere@chu-brest.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)

Description:

Aspiration of gastric contents can be a serious perioperative complication, which can be related to facemask positive pressure ventilation with unprotected airway. Even with low peak airway pressure (<15 cm H2O) gastric insufflation may occur. Since gastric content and volume assessment is a new point-of-care ultrasound recommended application, the cross-sectional antra area will be measured using ultrasonography before, continuously during facemask ventilation and after intubation.

Recruitment information / eligibility
Status Recruiting
Enrollment 123
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- ASA status I and II

Exclusion Criteria:

- 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Diagnostic ultrasonography of gastric volume
Ultrasonic measurement of gastric insufflation during positive pressure ventilation (secondary endpoint) and final gastric volume after positive pressure ventilation (primary endpoint)

Locations
Country Name City State
France CHRU de Brest Brest

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gastric volume before and after positive pressure ventilation 15 minutes
Secondary Ultrasonographic detection of gastric insufflation during ventilation 15 minutes
See also
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