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Clinical Trials/NCT04127331
NCT04127331
Completed
Not Applicable

Ultrasonographic Evaluation of Gastric Volume and Contents Before Surgery in Children

Alok Moharir1 site in 1 country100 target enrollmentJanuary 10, 2020
ConditionsSurgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
Alok Moharir
Enrollment
100
Locations
1
Primary Endpoint
Aspiration Risk Grade
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2020
End Date
September 6, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Alok Moharir
Responsible Party
Sponsor Investigator
Principal Investigator

Alok Moharir

Clinical Assistant Professor of Anesthesiology

Nationwide Children's Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • NPO at the Time of Injury(Baseline)
  • NPO at the Time of Surgery(Baseline)
  • Pre-operative Opioid Administration(Baseline)

Study Sites (1)

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