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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Positive-Pressure Respiration, Respiratory Aspiration of Gastric Content

Intervention / Treatment
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* Other: Diagnostic ultrasonography of gastric volume


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Manual-controlled<br>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<br>* Ultrasonic measurement of gastric insufflation during positive pressure ventilation (secondary endpoint) and final gastric volume after positive pressure ventilation (primary endpoint)<br>|
| Other: Volume-controlled<br>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<br>* Ultrasonic measurement of gastric insufflation during positive pressure ventilation (secondary endpoint) and final gastric volume after positive pressure ventilation (primary endpoint)<br>|
| Other: Pressure-controlled<br>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<br>* Ultrasonic measurement of gastric insufflation during positive pressure ventilation (secondary endpoint) and final gastric volume after positive pressure ventilation (primary endpoint)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric volume before and after positive pressure ventilation |  | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasonographic detection of gastric insufflation during ventilation |  | 15 minutes |