Gastric US in ICU Patient

NCT05526105 | Recruiting

• 1 other identifier: STUDY02001249
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Comparison of two different NPO protocol populations

  Within four months of study completion, 16 months from study start

• Peri-operative aspiration events

  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

  Zero to sixteen hours prior to surgery

Study Arms (2)

Standard ASA NPO Protocol

EXPERIMENTAL

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

Diagnostic Test: Gastric Ultrasound

Liberal Feeding Protocol

EXPERIMENTAL

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

Interventions

Gastric Ultrasound DIAGNOSTIC_TEST

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

Liberal Feeding Protocol; Standard ASA NPO Protocol

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

RECRUITING

MeSH Terms

Conditions

Critical Illness; Pneumonia, Aspiration; Hyperphagia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Laura M Chiang, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura M Chiang, MD

CONTACT

6036500360; laura.m.chiang@hitchcock.org

Laura M Chiang, MD

CONTACT

6036505922; laura.m.chiang@hitchcock.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology at the Geisel School of Medicine, Co-medical Director of the Surgical Intensive Care Unit

Model Details: Patients will be assigned to be NPO after midnight (standard protocol) or feed up until call to OR then decompressed (liberal protocol).

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: September 2, 2022
• Study Start: February 3, 2023
• Primary Completion: February 3, 2025
• Study Completion: February 3, 2025
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)