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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06303492
Enrollment
142
Registered
2024-03-12
Start date
2024-05-31
Completion date
2026-04-30
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergency Surgery, Pulmonary Aspiration

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.

Interventions

PROCEDUREGUS

Aspiration risk assessment by GUS

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of change in Anesthetic PlanBaselineThe 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.

Secondary

MeasureTime frameDescription
Percentage change in the three-category risk assessment before and after GUSBaselineThe 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

Contacts

Primary ContactCristian Arzola, MD, MSc
cristian.arzola@sinaihealth.ca416-586-4800
Backup ContactJonathan Sy
Jonathan.Sy@sinaihealth.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026