Ventilation and Gastric Insufflation During Three Levels of Inspiratory Pressure During Mask Ventilation
Primary Purpose
Gastric Ultrasonography, Gastric Insufflation, Mask Ventilation
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
peak inspiratory pressure 10 cmH2O
peak inspiratory pressure 15 cmH2O
peak inspiratory pressure 20 cmH2O
Sponsored by
About this trial
This is an interventional supportive care trial for Gastric Ultrasonography
Eligibility Criteria
Inclusion Criteria:
- adult patients (above 18 years)
- American society of anesthesiologist I-II
- scheduled for elective non-cardiac surgery under general anesthesia
Exclusion Criteria:
- increased risk of difficult mask ventilation
- patients at risk of aspiration
- Patients with craniofacial anomalies
- BMI >35 kg/m2
- pregnant patients
Sites / Locations
- Kasr Alaini HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
pressure 10
pressure 15
pressure 20
Arm Description
mask ventilation with peak inspiratory pressure of 10 cmH2O
mask ventilation with peak inspiratory pressure of 15 cmH2O
mask ventilation with peak inspiratory pressure of 20 cmH2O
Outcomes
Primary Outcome Measures
incidence of gastric insufflation by ultrasonography
gastric antrum cross sectional area increased by > 30% after endotracheal intubation in relation to the baseline
Secondary Outcome Measures
Gastric antrum cross sectional area
gastric antrum longitudinal diameter X anteroposterior diameter X π /4 in between contractions in supine position
tidal volume
mL
endtidal CO2
mmHg
peripheral O2 saturation
percentage
incidence of gastric insufflation by auscultation
gurgling sound by stethoscope
Full Information
NCT ID
NCT05020548
First Posted
August 19, 2021
Last Updated
September 10, 2021
Sponsor
Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05020548
Brief Title
Ventilation and Gastric Insufflation During Three Levels of Inspiratory Pressure During Mask Ventilation
Official Title
Evaluation of Adequacy of Ventilation and Gastric Insufflation During Three Levels of Inspiratory Pressure for Pressure-controlled Mask Ventilation During Induction of Anesthesia: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pulmonary aspiration of gastric contents is one of the leading causes of general anesthesia-related mortality. Gastric insufflation during positive pressure mask ventilation increases the gastric volume, and consequently the risk of regurgitation. Thus, positive pressure mask ventilation should be avoided during rapid sequence induction of anesthesia when full-stomach is suspected (e.g. inadequate fasting hours, gastrointestinal obstruction, delayed gastric emptying, and lower esophageal disease) Although avoidance of positive pressure mask ventilation during induction would potentially minimize the risk of aspiration, this would lead to rapid hypoxia . Hence, finding a proper regimen for mask ventilation would avoid hypoxia which might be serious in high-risk patients.
Pressure-controlled face mask ventilation previously proved to be the least regimen to cause gastric insufflation in comparison to manual, and volume-controlled mask ventilation during induction of anesthesia. Later, a pressure of 15 cmH2O during face mask ventilation had been reported optimum to achieve the balance between adequate ventilation and reduced gastric insufflation in non-paralyzed patients. This finding was not yet replicated in paralyzed patients who represent the majority of population who receive mask ventilation during induction of anesthesia. We hypothesize that in paralyzed patient, the optimum pressure during face mask ventilation might be lower than the pressure which was previously reported in non-paralyzed patients. However, no studies to the best of our knowledge had confirmed this hypothesis.
Gastric insufflation was previously evaluated using auscultation with stethoscope, microphone placed in the epigastric area, or esophageal manometry. Recently, gastric antrum ultrasound was used successfully to gastric insufflation in real time by measuring the cross sectional area of gastric antrum before and after face mask ventilation. This newly developed method is more sensitive than the auscultatory method and less invasive than esophageal manometry method.
Detailed Description
Upon arrival to the operating room, routine monitors (ECG, pulse oximetry, and non-invasive blood pressure monitor) will be applied, intravenous line will be secured, and routine pre-medications (ranitidine 50 mg and midazolam 3-5 mg) will be administrated. End-tidal CO2 monitoring will be initiated after induction of general anesthesia and starting face-mask ventilation. Induction of anesthesia will be achieved using fentanyl (2 mcg/Kg), propofol (2 mg/Kg), and rocuronium (0.6 mg/Kg). After loss of verbal response, mask ventilation will be achieved by appropriate size face mask and oropharyngeal airway with 100% oxygen and double hand jaw thrust head tilt maneuver. The included patients will be randomly allocated to receive the assigned pressure-controlled mask ventilation. The 3 study groups will receive the planned inspiratory pressure, without positive end-expiratory pressure, with a respiratory rate of 15, and inspiratory to expiratory ratio of 1:2 for 180 seconds.
Assessment gastric insufflation during mask ventilation will be achieved by ultrasound assessment of gastric antrum (in the sagittal plane between left lobe of the liver and pancreas at level of the aorta) and auscultation by two blinded investigators to the assigned pressure. The ultrasound screen will be positioned to be not visible to the investigator responsible for auscultation. Gastric insufflation will be identified by comet-tail sign by gastric ultrasound and gurgling sound by auscultation.
Gastric antrum cross sectional area [ D1(longitudinal diameter) X D2 (anteroposterior diameter) X π /4] in between contractions in supine position before face mask ventilation and after insertion of endotracheal tube will be recorded. gastric insufflation will be identified if gastric antrum cross sectional area increased by > 30% after endotracheal intubation in relation to the baseline.
During mask ventilation, the following parameter will be recorded at 30, 60, 90,120, 150 and 180 seconds; peripheral oxygen saturation, the end-tidal carbon dioxide concentration , peak airway measured pressure, and tidal volume Demographic data (age, sex, weight, height, BMI, comorbidities) will be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Ultrasonography, Gastric Insufflation, Mask Ventilation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
111 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pressure 10
Arm Type
Active Comparator
Arm Description
mask ventilation with peak inspiratory pressure of 10 cmH2O
Arm Title
pressure 15
Arm Type
Active Comparator
Arm Description
mask ventilation with peak inspiratory pressure of 15 cmH2O
Arm Title
pressure 20
Arm Type
Active Comparator
Arm Description
mask ventilation with peak inspiratory pressure of 20 cmH2O
Intervention Type
Other
Intervention Name(s)
peak inspiratory pressure 10 cmH2O
Intervention Description
pressure controlled mask ventilation with peak inspiratory pressure of 10 cmH2O
Intervention Type
Other
Intervention Name(s)
peak inspiratory pressure 15 cmH2O
Intervention Description
pressure controlled mask ventilation with peak inspiratory pressure of 15 cmH2O
Intervention Type
Other
Intervention Name(s)
peak inspiratory pressure 20 cmH2O
Intervention Description
pressure controlled mask ventilation with peak inspiratory pressure of 20 cmH2O
Primary Outcome Measure Information:
Title
incidence of gastric insufflation by ultrasonography
Description
gastric antrum cross sectional area increased by > 30% after endotracheal intubation in relation to the baseline
Time Frame
within 1 minute after endotracheal intubation
Secondary Outcome Measure Information:
Title
Gastric antrum cross sectional area
Description
gastric antrum longitudinal diameter X anteroposterior diameter X π /4 in between contractions in supine position
Time Frame
1 minute before mask ventilation and within 1 minute after endotracheal intubation
Title
tidal volume
Description
mL
Time Frame
at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
Title
endtidal CO2
Description
mmHg
Time Frame
at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
Title
peripheral O2 saturation
Description
percentage
Time Frame
at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
Title
incidence of gastric insufflation by auscultation
Description
gurgling sound by stethoscope
Time Frame
1 minute after onset of mask ventilation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients (above 18 years)
American society of anesthesiologist I-II
scheduled for elective non-cardiac surgery under general anesthesia
Exclusion Criteria:
increased risk of difficult mask ventilation
patients at risk of aspiration
Patients with craniofacial anomalies
BMI >35 kg/m2
pregnant patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed hasanin, M.D
Phone
01095076954
Ext
+2
Email
ahmedmohamedhasanin@gmail.com
Facility Information:
Facility Name
Kasr Alaini Hospital
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anesthesia, Pain Management and Surgical ICU Department
Phone
00201222224057
Email
Anesthesia.kasralainy@gmail.com
12. IPD Sharing Statement
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Ventilation and Gastric Insufflation During Three Levels of Inspiratory Pressure During Mask Ventilation
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