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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Aspiration; Emergency Surgery
• Intervention / Treatment: Procedure: GUS

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.

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristian Arzola, MD, MSc; Phone Number: 5270 416-586-4800; Email: cristian.arzola@sinaihealth.ca
• Study Contact Backup: Name: Jonathan Sy; Email: Jonathan.Sy@sinaihealth.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gastric ultrasound (GUS) group; Aspiration risk assessment using GUS in addition to the standard clinical assessment.	Procedure: GUS; Aspiration risk assessment by GUS
No Intervention: Control; Aspiration risk assessment only by standard clinical assessment, and no GUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of change in Anesthetic Plan	The primary outcome of the study is a change from the initial anesthetic plan after viewing GUS results in the intervention group, and after being given the opportunity to revise the plan in the control group.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in the three-category risk assessment before and after GUS	The secondary aim is only related to the intervention group, (1) to compare the aspiration risk assessment categories between the standard clinical assessment and GUS examination	Baseline

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: CTO 4096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No