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

NCT06303492 | Not Yet Recruiting

• 1 other identifier: CTO 4096
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage change in the three-category risk assessment before and after GUS

  Baseline

Study Arms (2)

Gastric ultrasound (GUS) group

EXPERIMENTAL

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

Procedure: GUS

Control

NO INTERVENTION

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

Interventions

GUS PROCEDURE

Aspiration risk assessment by GUS

Gastric ultrasound (GUS) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Central Study Contacts

Cristian Arzola, MD, MSc

CONTACT

416-586-4800; cristian.arzola@sinaihealth.ca

Jonathan Sy

CONTACT

Jonathan.Sy@sinaihealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 12, 2024
• Study Start: May 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share