Recruiting

Gastric Ultrasound

Sponsor:

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Code:

NCT06303492

Conditions

Pulmonary Aspiration

Emergency Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

GUS

Study Details

Brief summary:

Pulmonary aspiration of gastric contents is a serious patient safety problem accounting for 50% of anesthesia-related mortality. The risk is higher in patients undergoing emergency surgery as the gastric content is uncertain which poses a challenge to anesthetic decision-making. Standard clinical assessment to identify at-risk patients primarily relies on preoperative fasting guidelines and is not adequate for patients undergoing emergency surgeries. Point-of-care gastric ultrasound (GUS) has emerged as an accurate bedside tool providing information regarding the type and volume of gastric contents. When GUS was added to standard clinical assessment, anesthetic management plan changed in 71% of adult elective and 37% of pediatric emergency surgical procedures. Such data is lacking in adult patients undergoing emergency surgeries. The investigators propose a multicentre mixed-method study to evaluate the impact of GUS on aspiration risk assessment and subsequent Anesthetic Plan before emergency surgeries. The evidence from this study will improve patient safety by accurately identifying patients at risk of aspiration and tailoring anesthetic techniques and airway management to prevent pulmonary aspiration in patients undergoing emergency surgeries.

Conditions

Pulmonary Aspiration

Emergency Surgery

Study ID

NCT06303492

Start date

Jun 5, 2024

Status verified date

Oct, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 12, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age >18 years
  • American Society of Anesthesiologists' (ASA) physical status I-III
  • Patients scheduled for non-elective non-cardiac surgery.

Exclusion Criteria:

  • Abnormal anatomy of the upper gastro-intestinal tract (including hiatus hernia, gastric tumors, and previous surgeries of the upper gastrointestinal tract).
  • Extrinsic gastric compression obtained from the medical history or during the actual ultrasound examination.
  • Pregnancy.
  • Attending anesthesiologist refusal to include the patient for participation in the study

Study Design

Enrollment

142 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Gastric ultrasound (GUS) group

Aspiration risk assessment using GUS in addition to the standard clinical assessment.

no intervention: Control

Aspiration risk assessment only by standard clinical assessment, and no GUS

Interventions

GUS

Aspiration risk assessment by GUS

Primary outcome measure

  • Proportion of change in Anesthetic Plan [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Locations

Department of Anesthesia Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

More Information

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Last update posted

Oct 28, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-29. This information was provided to ClinicalTrials.gov by Samuel Lunenfeld Research Institute, Mount Sinai Hospital on 2026-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.