Gastric US in ICU Patient

June 26, 2024 updated by: Laura M. Chiang, Dartmouth-Hitchcock Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard ASA NPO Protocol
Patients will be made NPO at midnight prior to date of surgery.
Diagnostic test: Gastric Ultrasound
Gastric ultrasound in the supine and right lateral decubitus position for patients going for operative intervention with a protected airway.
Experimental: Liberal Feeding Protocol
Patients will be fed enterally up until call to OR at which time their stomachs will be decompressed with a pre-existing gastric tube.
Diagnostic test: Gastric Ultrasound
Gastric ultrasound in the supine and right lateral decubitus position for patients going for operative intervention with a protected airway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric Residual Volumes
Time Frame: 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.
Within one hour of operative intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of two different NPO protocol populations
Time Frame: 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).
Within four months of study completion, 16 months from study start
Peri-operative aspiration events
Time Frame: Within four months of study completion, 16 months from study start
Number of aspiration events per number of operative interventions.
Within four months of study completion, 16 months from study start
Estimation of the amount of enteral nutrition lost prior to surgery using the different NPO protocols
Time Frame: Zero to sixteen hours prior to surgery
Calculation of enteral nutrition held during NPO time in kilocalories.
Zero to sixteen hours prior to surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Laura M Chiang, MD, Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2023

Primary Completion (Estimated)

February 3, 2025

Study Completion (Estimated)

February 3, 2025

Study Registration Dates

First Submitted

August 15, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY02001249

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe