Gastric US in ICU Patient

Surgery Clinical Trial

Official title:

Gastric Ultrasound in Critically Ill Patients for Evaluation of Gastric Volume Residuals; A Comparison of NPO Protocols

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05526105
• Other study ID #: STUDY02001249
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: July 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Alessandra C Bryan, BS/BA
• Phone: 6036500360
• Email: alessandra.c.bryan[@]hitchcock.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Critical Illness
• Pneumonia, Aspiration
• Surgery

Intervention

Diagnostic Test:
• Gastric Ultrasound
Gastric ultrasound in the supine and right lateral decubitus position for patients going for operative intervention with a protected airway.

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric Residual Volumes	Quantification of gastric residual volumes as measured in milliliters using antral cross-sectional areas and semi-quantitative gastric volumes using standardized grading scores.	Within one hour of operative intervention.
Secondary	Comparison of two different NPO protocol populations	Comparing standard ASA NPO protocol vs liberal, feed-up-until-call to OR protocol as defined by comparison of gastric volumes (mLs).	Within four months of study completion, 16 months from study start
Secondary	Peri-operative aspiration events	Number of aspiration events per number of operative interventions.	Within four months of study completion, 16 months from study start
Secondary	Estimation of the amount of enteral nutrition lost prior to surgery using the different NPO protocols	Calculation of enteral nutrition held during NPO time in kilocalories.	Zero to sixteen hours prior to surgery