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Intra- and Interrater Reliability of Quantitative Ultrasound Assessment of Gastric Content in Term Parturients Before Elective Caesarean Delivery

Primary Purpose

Pregnancy, Respiratory Aspiration of Gastric Content

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pregnancy focused on measuring Gastric Ultrasound

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: non-laboring term pregnant women scheduled for cesarean delivery under neuraxial anesthesia ≥37 weeks gestational age ≥18 years of age ASA physical status II-III weight 50 to 120 kg height ≥150 cm ability to understand the rationale of the study evaluations. Exclusion Criteria: multiple pregnancy known (reported by the study subject) anomalous anatomy of the upper gastrointestinal tract previous surgical procedures on the esophagus, stomach or upper abdomen patients not following our institutional fasting instructions (8 hours after a meal and 2 hours for clear liquids)

Sites / Locations

  • Mount Sinai HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gastric Ultrasound

Arm Description

Ultrasound measurements of the antrum will be recorded.

Outcomes

Primary Outcome Measures

Antral cross-sectional area (supine position)
The cross-sectional area (in centimeters squared) of the antrum will be measured with the patient in supine position, using the ultrasound machine. Measurements will be done 3 times, by 2 investigators.
Antral cross-sectional area (right lateral decubitus)
The cross-sectional area (in centimeters squared) of the antrum will be measured with the patient in right lateral decubitus position, using the ultrasound machine. Measurements will be done 3 times, by 2 investigators.

Secondary Outcome Measures

Intra-rater reliability calculation
Intra-rater reliability will be calculated using the 3 measurements, for each rater.
Inter-rater reliability calculation
Inter-rater reliability will be calculated using the 3 measurements, between raters.
Grading of stomach contents
Grading scale: grade 0 means no gastric contents are visualized in supine and the right lateral decubitus, grade 1 means gastric contents are visualized in right lateral decubitus but not in supine decubitus, and grade 2 means gastric contents are visualized in both positions
Gastric volume (supine position)
Gastric volume (ml) will be estimated using the antral cross-sectional area obtained with the patient in supine position
Gastric volume (right lateral decubitus)
Gastric volume (ml) will be estimated using the antral cross-sectional area obtained with the patient in right lateral decubitus.

Full Information

First Posted
June 27, 2023
Last Updated
August 16, 2023
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05946447
Brief Title
Intra- and Interrater Reliability of Quantitative Ultrasound Assessment of Gastric Content in Term Parturients Before Elective Caesarean Delivery
Official Title
Intra- and Interrater Reliability of Quantitative Ultrasound Assessment of Gastric Content in Term Parturients Before Elective Caesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai 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
The presence of solid food or fluid residue in the stomach is always a major concern when patients require medical procedures under sedation or general anesthesia, due to the high risk of pulmonary aspiration of the stomach contents. This is especially important in emergency procedures, when a fasting period could not be observed. Pulmonary aspiration of gastric content is a serious perioperative complication of obstetric anesthesia, and it is associated with morbidity and mortality. Information from a bedside ultrasound assessment of the stomach may be a very useful resource to decide whether it's safe to proceed, cancel or delay a surgical procedure. The ultrasound assessment of the stomach content has shown to be very feasible and practical in non-pregnant patients. However, it has not been determined whether the competence reached by anesthesiologists in non-pregnant subjects can be transferred to the obstetric population, especially in term pregnant patients where it could be difficult to identify the stomach because of the presence of the gravid uterus. Although quantitative assessment of the gastric antrum cross-sectional area in terms of intra- and interrater reliability has been evaluated in non-pregnant adults, it remains to be evaluated in pregnant patients. Furthermore, it has not been determined whether the performance of novice operators is comparable to expert operators in the gastric quantitative assessment. This study aims to determine whether trained anesthesiologists can reliably assess the stomach content of pregnant patients by ultrasound, evaluating the inter- and intra-rater reliability of quantitative gastric ultrasound in term pregnant patients comparing anesthesiologists of different level of expertise. The investigators hypothesize a substantial to almost perfect agreement in the intra- and interrater reliability of the antral cross-sectional area among raters in term pregnant patients scheduled for elective cesarean delivery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Respiratory Aspiration of Gastric Content
Keywords
Gastric Ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gastric Ultrasound
Arm Type
Experimental
Arm Description
Ultrasound measurements of the antrum will be recorded.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Other Intervention Name(s)
Gastric Ultrasound
Intervention Description
The gastric antrum will be scanned using ultrasound.
Primary Outcome Measure Information:
Title
Antral cross-sectional area (supine position)
Description
The cross-sectional area (in centimeters squared) of the antrum will be measured with the patient in supine position, using the ultrasound machine. Measurements will be done 3 times, by 2 investigators.
Time Frame
5 minutes
Title
Antral cross-sectional area (right lateral decubitus)
Description
The cross-sectional area (in centimeters squared) of the antrum will be measured with the patient in right lateral decubitus position, using the ultrasound machine. Measurements will be done 3 times, by 2 investigators.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Intra-rater reliability calculation
Description
Intra-rater reliability will be calculated using the 3 measurements, for each rater.
Time Frame
5 minutes
Title
Inter-rater reliability calculation
Description
Inter-rater reliability will be calculated using the 3 measurements, between raters.
Time Frame
5 minutes
Title
Grading of stomach contents
Description
Grading scale: grade 0 means no gastric contents are visualized in supine and the right lateral decubitus, grade 1 means gastric contents are visualized in right lateral decubitus but not in supine decubitus, and grade 2 means gastric contents are visualized in both positions
Time Frame
5 minutes
Title
Gastric volume (supine position)
Description
Gastric volume (ml) will be estimated using the antral cross-sectional area obtained with the patient in supine position
Time Frame
5 minutes
Title
Gastric volume (right lateral decubitus)
Description
Gastric volume (ml) will be estimated using the antral cross-sectional area obtained with the patient in right lateral decubitus.
Time Frame
5 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: non-laboring term pregnant women scheduled for cesarean delivery under neuraxial anesthesia ≥37 weeks gestational age ≥18 years of age ASA physical status II-III weight 50 to 120 kg height ≥150 cm ability to understand the rationale of the study evaluations. Exclusion Criteria: multiple pregnancy known (reported by the study subject) anomalous anatomy of the upper gastrointestinal tract previous surgical procedures on the esophagus, stomach or upper abdomen patients not following our institutional fasting instructions (8 hours after a meal and 2 hours for clear liquids)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristian Arzola, MD
Phone
416-586-4800
Ext
2931
Email
cristian.arzola@sinaihealth.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristian Arzola, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristian Arzola, MD
Phone
416-586-4800
Ext
2931
Email
cristian.arzola@sinaihealth.ca
First Name & Middle Initial & Last Name & Degree
Juan Pablo Ghiringhelli, MD
First Name & Middle Initial & Last Name & Degree
Lada Kordich, MD
First Name & Middle Initial & Last Name & Degree
Naveed Siddiqui, MD
First Name & Middle Initial & Last Name & Degree
Jose Carvalho, MD
First Name & Middle Initial & Last Name & Degree
Ronald George, MD
First Name & Middle Initial & Last Name & Degree
Kristi Downey, MSc

12. IPD Sharing Statement

Learn more about this trial

Intra- and Interrater Reliability of Quantitative Ultrasound Assessment of Gastric Content in Term Parturients Before Elective Caesarean Delivery

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