Aspiration Risk Assessment by Gastric Ultrasound in eMErgency Surgery and ANesThetic Decision-making: The ARGUMENT Study

NCT ID: NCT06303492

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2026-04-30

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.

Detailed Description

The proposed trial design is a mixed-method, multicenter study that includes a randomized controlled trial (RCT) and a qualitative assessment component. The RCT will evaluate the impact of adding GUS to the standard clinical assessment on the incidence of changes in the anesthetic plan for adult patients undergoing emergency surgery. The qualitative assessment will gather attending anesthesiologists' opinions on the addition of GUS in an emergency surgical setting.

Conditions

Pulmonary Aspiration; Emergency Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Gastric ultrasound (GUS) group

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

Group Type: EXPERIMENTAL

GUS

Intervention Type: PROCEDURE

Aspiration risk assessment by GUS

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

GUS

Aspiration risk assessment by GUS

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Cristian Arzola, MD, MSc

Role: CONTACT

cristian.arzola@sinaihealth.ca

416-586-4800 ext. 5270

Jonathan Sy

Role: CONTACT

Jonathan.Sy@sinaihealth.ca

Other Identifiers

CTO 4096

Identifier Type: -

Identifier Source: org_study_id