Gastric US in ICU Patient

Not Applicable

Recruiting

• Conditions: Aspiration Pneumonia; Critical Illness; Surgery
• Interventions: Diagnostic Test: Gastric Ultrasound

• Registration Number: NCT05526105
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

This is a case series study using gastric ultrasound in critically ill patients to quantify gastric residual volumes to compare the efficacy of different NPO protocols.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-02
• Study Start: 2023-02-03
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27
• Primary Completion: 2025-02-03
• Study Completion: 2025-02-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients age 18 or older, admitted to the ICU, requiring general anesthesia or sedation for a procedure with a pre-existing, cuffed endotracheal or tracheostomy tube. Most patients admitted to the ICU would be unable to consent.

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Exclusion Criteria

• Known upper gastrointestinal anatomical problem that would prevent accurate estimation of gastric volume, gastric perforation, pregnancy beyond the first trimester.
• Lack of a pre-existing, cuffed endotracheal or tracheostomy tube.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liberal Feeding Protocol	Gastric Ultrasound	Patients will be fed enterally up until call to OR at which time their stomachs will be decompressed with a pre-existing gastric tube.
Standard ASA NPO Protocol	Gastric Ultrasound	Patients will be made NPO at midnight prior to date of surgery.

Primary Outcome Measures

Name	Time	Method
Gastric Residual Volumes	Within one hour of operative intervention.	Quantification of gastric residual volumes as measured in milliliters using antral cross-sectional areas and semi-quantitative gastric volumes using standardized grading scores.

Secondary Outcome Measures

Name	Time	Method
Peri-operative aspiration events	Within four months of study completion, 16 months from study start	Number of aspiration events per number of operative interventions.
Estimation of the amount of enteral nutrition lost prior to surgery using the different NPO protocols	Zero to sixteen hours prior to surgery	Calculation of enteral nutrition held during NPO time in kilocalories.
Comparison of two different NPO protocol populations	Within four months of study completion, 16 months from study start	Comparing standard ASA NPO protocol vs liberal, feed-up-until-call to OR protocol as defined by comparison of gastric volumes (mLs).

Trial Locations

Locations (1)

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States