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OpenTrials
Completed

NCT Number: NCT04127331

Gastric Ultrasound

The primary objective of this study is to evaluate gastric volume and contents as well as gall bladder size in patients scheduled for routine, urgent, and emergency surgery. The hypothesis is that patients with stress, pain and opioid administration will have delayed gastric emptying and therefore a larger gastric fluid volume than those scheduled for elective surgery. The patients who have an appropriate NPO time will have a larger gallbladder size than the patients with shorter NPO time.

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Key information

Conditions

Surgery

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA 1-3 patients aged 2-18 years of scheduled for elective, urgent, or emergent surgery under general anesthesia.

Exclusion criteria

  • History of upper gastro-intestinal surgery.

Treatment and study plan

Point-of-Care Ultrasound

Device

Portable ultrasonography done at the bedside.

Primary outcomes

  1. Aspiration Risk Grade

    Time frame: Baseline

    Grade 0: No fluid visible in the gastric antrum Grade 1: Clear fluid visualized with volume < 1.5 mL/kg Grade 2: Clear fluid visualized with volume > 1.5 mL/kg (High risk of aspiration)

Secondary outcomes

  1. NPO at the Time of Injury

    Time frame: Baseline

    Amount of time the patient was without food or water prior to their injury. This only applies to the Semi-urgent and Urgent groups.

  2. NPO at the Time of Surgery

    Time frame: Baseline

    Amount of time the patient was without food or water prior to their surgery.

  3. Pre-operative Opioid Administration

    Time frame: Baseline

    Patients who received opioids for pain control prior to surgery.

Sponsors and collaborators

Lead sponsor

Alok Moharir

Other

Registry information

Official study title

Ultrasonographic Evaluation of Gastric Volume and Contents Before Surgery in Children

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 15, 2019
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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