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

Not Applicable

• Conditions: Positive-Pressure Respiration; Respiratory Aspiration of Gastric Content
• Interventions: Other: Diagnostic ultrasonography of gastric volume

• Registration Number: NCT02906267
• Lead Sponsor: University Hospital, Brest

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)

Detailed 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.

Study Timeline

• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-14
• Study First Posted: 2016-09-20
• Study Start: 2016-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-17
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 123

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual-controlled	Diagnostic ultrasonography of gastric volume	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.
Volume-controlled	Diagnostic ultrasonography of gastric volume	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.
Pressure-controlled	Diagnostic ultrasonography of gastric volume	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.

Primary Outcome Measures

Name	Time	Method
Gastric volume before and after positive pressure ventilation	15 minutes

Secondary Outcome Measures

Name	Time	Method
Ultrasonographic detection of gastric insufflation during ventilation	15 minutes

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France