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

NCT ID: NCT05946447

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-20
• Study Completion Date: 2023-10-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Gastric Ultrasound

Ultrasound measurements of the antrum will be recorded.

Group Type: EXPERIMENTAL

Ultrasound

Intervention Type: DEVICE

The gastric antrum will be scanned using ultrasound.

Interventions

Ultrasound

The gastric antrum will be scanned using ultrasound.

Intervention Type: DEVICE

Other Intervention Names

Gastric Ultrasound

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cristian Arzola, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

23-02

Identifier Type: -

Identifier Source: org_study_id