Ignite Creation Date:
2025-12-24 @ 3:26 PM
Ignite Modification Date:
2025-12-26 @ 8:23 PM
Study NCT ID:
NCT06303492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aspiration Risk Assessment by Gastric Ultrasound in eMErgency Surgery and ANesThetic Decision-making: The ARGUMENT Study
Sponsor:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: