NCT04228497

Brief Summary

Ultrasound guided comparison of gastric residual volume after clear fluid fasting for one versus two hours in pediatrics scheduled for elective surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2021

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

January 11, 2020

Last Update Submit

September 13, 2021

Conditions

Gastric Emptying

Keywords

Gastric residual volume; children; ultrasound; fasting

Outcome Measures

Primary Outcomes (1)

  • GRV in right lateral position after one-hour clear fluid intake.

    one-hour of clear fluid intake

Secondary Outcomes (6)

  • Antral cross-sectional area in right lateral position after one-hour clear fluid intake

    one-hour clear fluid intake

  • Antral cross-sectional area in right lateral and supine positions after two hours clear fluid intake

    two hours clear fluid intake

  • Gastric residual volume in supine position in both groups

    one hour after clear fluid intake

  • Grade of aspiration risk (frequency of high risk and low risk)

    one and two hours after clear fluid intake

  • Qualitative grading for assessment of gastric antrum: three-point grading will be evaluated

    one and two hours after clear fluid intake

  • +1 more secondary outcomes

Study Arms (2)

clear fluids fasting for one hour

ACTIVE COMPARATOR

children fasting for 6 to 8 hours will be allowed to drink 3 mL/kg of apple juice to a maximum of 250 ml one hour before surgery

Device: gastric ultrasoundOther: the clear fluid intake

clear fluids fasting for two hours

PLACEBO COMPARATOR

children fasting for 6 to 8 hours will be allowed to drink 3 mL/kg of apple juice to a maximum of 250 ml two hours before surgery

Device: gastric ultrasoundOther: the clear fluid intake

Interventions

gastric ultrasoundDEVICE

Children in both groups will be scanned in two positions: supine position and right lateral position (RLP) one and two hours following the clear fluid intake and before admission to the operation room in groups 1 and 2 respectively. Gastric antrum will be located in the sagittal plane with simultaneous identification of left lobe of the liver and the descending abdominal aorta or inferior vena cava.

clear fluids fasting for one hourclear fluids fasting for two hours
the clear fluid intakeOTHER

the clear fluid intake

clear fluids fasting for one hourclear fluids fasting for two hours

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • ASA physical state I or II
  • Age 3 to 10 years.
  • Gender: both sexes.
  • Scheduled for non-GIT elective day-case surgery under general anesthesia with endotracheal intubation.

You may not qualify if:

  • Parent/ care giver refusal
  • Ages \< 3 or \> 10 years old
  • Children with gastro-esophageal reflux disease (GORD): either on treatment or under investigation
  • Renal failure, Diabetes mellitus and cerebral palsy patients
  • Esophageal strictures, achalasia or any intestinal disease that may impair the gastric emptying.
  • GIT surgery and neurosurgical patients
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasralainy

Cairo, Egypt

Location

Related Publications (1)

  • Sarhan KA, Hasaneen H, Hasanin A, Mohammed H, Saleh R, Kamel A. Ultrasound Assessment of Gastric Fluid Volume in Children Scheduled for Elective Surgery After Clear Fluid Fasting for 1 Versus 2 Hours: A Randomized Controlled Trial. Anesth Analg. 2023 Apr 1;136(4):711-718. doi: 10.1213/ANE.0000000000006157. Epub 2022 Jul 16.

    PMID: 35881513DERIVED

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Khaled A Sarhan, MD

    Lecturer of anesthesia, Cairo university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 11, 2020

First Posted

January 14, 2020

Study Start

January 1, 2020

Primary Completion

March 10, 2021

Study Completion

March 10, 2021

Last Updated

September 17, 2021

Record last verified: 2021-09

Locations

EG(1)