Back to resultsUltrasonographic Comparison of Gastric Volume After Three Modes of Positive Facemask During Induction of Anaesthesia (UGV)
Primary Purpose
Positive-Pressure Respiration, Respiratory Aspiration of Gastric Content
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diagnostic ultrasonography of gastric volume
Sponsored by
About this trial
This is an interventional diagnostic trial for Positive-Pressure Respiration
Eligibility Criteria
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
Sites / Locations
- CHRU de BrestRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Manual-controlled
Volume-controlled
Pressure-controlled
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Gastric volume before and after positive pressure ventilation
Secondary Outcome Measures
Ultrasonographic detection of gastric insufflation during ventilation
Full Information
NCT ID
NCT02906267
First Posted
September 5, 2016
Last Updated
July 13, 2017
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT02906267
Brief Title
Ultrasonographic Comparison of Gastric Volume After Three Modes of Positive Facemask During Induction of Anaesthesia
Acronym
UGV
Official Title
Ultrasonographic Comparison of Gastric Volume After Three Modes of Positive Facemask. A Prospective Randomized Study.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Brest
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Positive-Pressure Respiration, Respiratory Aspiration of Gastric Content
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
123 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Manual-controlled
Arm Type
Other
Arm Description
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.
Arm Title
Volume-controlled
Arm Type
Other
Arm Description
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.
Arm Title
Pressure-controlled
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Diagnostic ultrasonography of gastric volume
Intervention Description
Ultrasonic measurement of gastric insufflation during positive pressure ventilation (secondary endpoint) and final gastric volume after positive pressure ventilation (primary endpoint)
Primary Outcome Measure Information:
Title
Gastric volume before and after positive pressure ventilation
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Ultrasonographic detection of gastric insufflation during ventilation
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre LAFERE, MD, PhD
Phone
0033298347658
Email
pierre.lafere@chu-brest.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre LAFERE, MD,PhD
Organizational Affiliation
CHRU de Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Brest
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre LAFERE, MD, PhD
Email
pierre.lafere@chu-brest.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Ultrasonographic Comparison of Gastric Volume After Three Modes of Positive Facemask During Induction of Anaesthesia
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