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Gastric Insufflation During Facemask Ventilation at Different Levels of End-expiratory Pressure in Obese Patients

Primary Purpose

Gastric Insufflation, Face-mask Ventilation, Obese

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
zero PEEP
low PEEP
high PEEP
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gastric Insufflation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adult patients, with American Society of Anesthesiologists physical status II, body mass index >35 kg/m2, scheduled for elective surgery under general anesthesia. Exclusion Criteria: Patients at increased risk of difficult mask ventilation: Mallampati classification >2, presence of beard, limited neck extension, limited jaw protrusion, patients with history of obstructive sleep apnea or STOP-Bang score>2 Patients at risk of aspiration or history of esophageal reflux. Patients with craniofacial anomalies, and 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

ZEEP group

Low PEEP

High PEEP

Arm Description

Outcomes

Primary Outcome Measures

Change in gastric cross sectional area more than 30%
number of patients with increase in percentage of change in gastric cross sectional area by more than 30%

Secondary Outcome Measures

gastric cross sectional area
gastric cross sectional area measured by ultrasonography in cm2
percentage of change in gastric cross sectional area
gastric cross sectional area after intubation divided by gastric cross sectional area before preoxygenation %
tidal volume
mL/kg
end-tidal CO2
mmHg
Peak airway pressure
mmHg
Gastric insufflation
incidence of gastric insufflation by auscultation

Full Information

First Posted
July 30, 2023
Last Updated
October 16, 2023
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05979129
Brief Title
Gastric Insufflation During Facemask Ventilation at Different Levels of End-expiratory Pressure in Obese Patients
Official Title
Comparing the Incidence of Gastric Insufflation During Facemask Ventilation at Different Levels of End-expiratory Pressure During Induction of Anesthesia in Obese Patients: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 6, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (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
Gastric insufflation occurs when the inspiratory pressure exceeds the lower esophageal sphincter pressure. Thus, it is desirable to avoid excessive positive pressure during mask ventilation after induction of anesthesia and keeping the inspiratory pressure <15-20 cmH2O.In patients with obesity the lower compliance of the respiratory system usually requires higher inspiratory pressures to maintain adequate ventilation making these patients more prone to gastric insufflation. This high risk of gastric insufflation can be aggravated by the use of positive end-expiratory pressure (PEEP) which is recommended to avoid lung atelectasis. The application of PEEP during mask ventilation increases the risk of gastric insufflation as it reduces the pressure threshold at which gastric insufflation occur The optimum ventilatory strategy during mask ventilation should achieve the balance between adequate lung ventilation and avoiding gastric insufflation. In obese patients, it is not clear whether the use of PEEP during mask ventilation would increase the risk of gastric insufflation or not. We hypothesize that using zero end-expiratory pressure (ZEEP) or low PEEP during mask ventilation would reduce the risk of gastric insufflation in comparison to high PEEP.
Detailed Description
Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied, intravenous line will be secured. End-tidal CO2 monitoring will be initiated after induction of general anesthesia and starting face-mask ventilation. All patients will be positioned in the ramped position (achieved by elevation of the head and shoulders till achieving alignment of sternal notch and external auditory meatus). Preoxygenation will be achieved by pressure support ventilation with 5 cmH2O and FiO2 of 0.8 without PEEP for three minutes. Induction of anesthesia will be achieved using fentanyl (2 mcg/Kg lean body weight), propofol (2 mg/Kg lean body weight), and rocuronium (0.6 mg/Kg ideal body weight). 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 receiving volume-controlled ventilation adjusted to deliver tidal volume of 8-10 mL/kg (ideal body weight), at I:E ratio of 1:2, inspiratory pause of 0.5 s, respiratory rate of 12 breath per minute, FiO2 of 0.8. The 3 study groups will receive the planned ventilatory strategy for 120 seconds. Assessment gastric insufflation during mask ventilation will be achieved by ultrasound assessment of gastric antrum (at the sagittal plane between left lobe of the liver and pancreas at level of the aorta). Gastric antral cross-sectional area (CSA) [ (longitudinal diameter) X (anteroposterior diameter) X π /4] will be assessed in between contractions before face mask ventilation and after insertion of endotracheal tube. [9] The proportion of change in the CSA will be calculated as (delta CSA %= [CSA after intubation - baseline CSA] / baseline CSA X 100). Significant gastric insufflation will be identified if the CSA increased by > 30% after endotracheal intubation in relation to the baseline. Intermittent gastric auscultation will be performed during mask ventilation at 30, 60, 90, 120 seconds by a blinded investigator (the presence of gastric insufflation will be defined as a gurgling sound).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Insufflation, Face-mask Ventilation, Obese, Positive End Expiratory Pressure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ZEEP group
Arm Type
Active Comparator
Arm Title
Low PEEP
Arm Type
Active Comparator
Arm Title
High PEEP
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
zero PEEP
Intervention Description
zero end-expiratory pressure during face mask ventilation
Intervention Type
Other
Intervention Name(s)
low PEEP
Intervention Description
4 cmH2O PEEP during mask ventilation
Intervention Type
Other
Intervention Name(s)
high PEEP
Intervention Description
8 cmH2O PEEP during mask ventilation
Primary Outcome Measure Information:
Title
Change in gastric cross sectional area more than 30%
Description
number of patients with increase in percentage of change in gastric cross sectional area by more than 30%
Time Frame
1 minute before preoxygenation and 1 minute after intubation
Secondary Outcome Measure Information:
Title
gastric cross sectional area
Description
gastric cross sectional area measured by ultrasonography in cm2
Time Frame
1 minute before preoxygenation and 1 minute after intubation
Title
percentage of change in gastric cross sectional area
Description
gastric cross sectional area after intubation divided by gastric cross sectional area before preoxygenation %
Time Frame
1 minute before preoxygenation and 1 minute after intubation
Title
tidal volume
Description
mL/kg
Time Frame
30 seconds until 120 seconds after induction of anesthesia
Title
end-tidal CO2
Description
mmHg
Time Frame
30 seconds until 120 seconds after induction of anesthesia
Title
Peak airway pressure
Description
mmHg
Time Frame
30 seconds until 120 seconds after induction of anesthesia
Title
Gastric insufflation
Description
incidence of gastric insufflation by auscultation
Time Frame
30 seconds until 120 seconds after induction of anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients, with American Society of Anesthesiologists physical status II, body mass index >35 kg/m2, scheduled for elective surgery under general anesthesia. Exclusion Criteria: Patients at increased risk of difficult mask ventilation: Mallampati classification >2, presence of beard, limited neck extension, limited jaw protrusion, patients with history of obstructive sleep apnea or STOP-Bang score>2 Patients at risk of aspiration or history of esophageal reflux. Patients with craniofacial anomalies, and pregnant patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed hasanin
Phone
01095076954
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

Plan to Share IPD
No
IPD Sharing Plan Description
data from this study will be available from PI upon reasonable request

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Gastric Insufflation During Facemask Ventilation at Different Levels of End-expiratory Pressure in Obese Patients

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