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Gastric US in ICU Patient

Primary Purpose

Critical Illness, Surgery, Aspiration Pneumonia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gastric Ultrasound
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Critical Illness focused on measuring NPO Protocols, Intensive Care Unit, Gastric Ultrasound, Ultrasound, Surgical Intensive Care Unit, NPO, Nasogastric Tube, Orogastric Tube, Enteral Nutrition, Parenteral Nutrition, Gastric Residual Volume, Aspiration, Critical Illness Nutrition

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dartmouth Hitchcock Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard ASA NPO Protocol

Liberal Feeding Protocol

Arm Description

Patients will be made NPO at midnight prior to date of surgery.

Patients will be fed enterally up until call to OR at which time their stomachs will be decompressed with a pre-existing gastric tube.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Peri-operative aspiration events
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
Calculation of enteral nutrition held during NPO time in kilocalories.

Full Information

First Posted
August 15, 2022
Last Updated
July 31, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05526105
Brief Title
Gastric US in ICU Patient
Official Title
Gastric Ultrasound in Critically Ill Patients for Evaluation of Gastric Volume Residuals; A Comparison of NPO Protocols
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Surgery, Aspiration Pneumonia
Keywords
NPO Protocols, Intensive Care Unit, Gastric Ultrasound, Ultrasound, Surgical Intensive Care Unit, NPO, Nasogastric Tube, Orogastric Tube, Enteral Nutrition, Parenteral Nutrition, Gastric Residual Volume, Aspiration, Critical Illness Nutrition

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be assigned to be NPO after midnight (standard protocol) or feed up until call to OR then decompressed (liberal protocol).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard ASA NPO Protocol
Arm Type
Experimental
Arm Description
Patients will be made NPO at midnight prior to date of surgery.
Arm Title
Liberal Feeding Protocol
Arm Type
Experimental
Arm Description
Patients will be fed enterally up until call to OR at which time their stomachs will be decompressed with a pre-existing gastric tube.
Intervention Type
Diagnostic Test
Intervention Name(s)
Gastric Ultrasound
Intervention Description
Gastric ultrasound in the supine and right lateral decubitus position for patients going for operative intervention with a protected airway.
Primary Outcome Measure Information:
Title
Gastric Residual Volumes
Description
Quantification of gastric residual volumes as measured in milliliters using antral cross-sectional areas and semi-quantitative gastric volumes using standardized grading scores.
Time Frame
Within one hour of operative intervention.
Secondary Outcome Measure Information:
Title
Comparison of two different NPO protocol populations
Description
Comparing standard ASA NPO protocol vs liberal, feed-up-until-call to OR protocol as defined by comparison of gastric volumes (mLs).
Time Frame
Within four months of study completion, 16 months from study start
Title
Peri-operative aspiration events
Description
Number of aspiration events per number of operative interventions.
Time Frame
Within four months of study completion, 16 months from study start
Title
Estimation of the amount of enteral nutrition lost prior to surgery using the different NPO protocols
Description
Calculation of enteral nutrition held during NPO time in kilocalories.
Time Frame
Zero to sixteen hours prior to surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandra C Bryan, BS/BA
Phone
6036500360
Email
alessandra.c.bryan@hitchcock.org
First Name & Middle Initial & Last Name or Official Title & Degree
Laura M Chiang, MD
Phone
6036505922
Email
laura.m.chiang@hitchcock.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura M Chiang, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Chiang, MD
Email
laura.m.chiang@hitchcock.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Gastric US in ICU Patient

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