Recruiting

Gastric Ultrasound

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT05526105

Conditions

Critical Illness

Surgery

Aspiration Pneumonia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Gastric Ultrasound

Study Details

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

Study ID

NCT05526105

Start date

Feb 3, 2023

Status verified date

Jun, 2024

Completion date

Feb 3, 2025

Anticipated

Primary completion date

Feb 3, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Standard ASA NPO Protocol

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

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.

Interventions

Gastric Ultrasound

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

Primary outcome measure

  • Gastric Residual Volumes [ Time Frame: Within one hour of operative intervention. ]

Central Contacts and Locations

Central contacts

Locations

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03766

Contacts

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Jun 27, 2024

Last verified

Jun, 2024

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2024-06-27.