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

NCT05946447 | Completed

• 1 other identifier: 23-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Respiratory Aspiration of Gastric Content

Keywords

Gastric Ultrasound

Outcome Measures

Primary Outcomes (2)

• 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.

  5 minutes

• 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.

  5 minutes

Secondary Outcomes (5)

• Intra-rater reliability calculation

  5 minutes

• Inter-rater reliability calculation

  5 minutes

• Grading of stomach contents

  5 minutes

• Gastric volume (supine position)

  5 minutes

• Gastric volume (right lateral decubitus)

  5 minutes

Study Arms (1)

Gastric Ultrasound

EXPERIMENTAL

Ultrasound measurements of the antrum will be recorded.

Device: Ultrasound

Interventions

Ultrasound DEVICE

The gastric antrum will be scanned using ultrasound.

Also known as: Gastric Ultrasound

Gastric Ultrasound

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Cristian Arzola, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 14, 2023
• Study Start: July 20, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

CA (1)