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

Emergency Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06303492
• Other study ID #: CTO 4096
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: April 2026

Study information

• Verified date: February 2024
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: Cristian Arzola, MD, MSc
• Phone: 416-586-4800
• Email: cristian.arzola[@]sinaihealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 142
• Est. completion date: April 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Emergency Surgery
• Pulmonary Aspiration

Intervention

Procedure:
• GUS
Aspiration risk assessment by GUS

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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