NCT03747796

Brief Summary

The aim of this work is to evaluate the effect of semi sitting versus supine positions on gastric emptying of fluids in children using gastric ultrasound. The investigators hypothesize that gastric emptying in children might be faster if the patient is in semi-sitting position. This hypothesis could impact the current guidelines for peri-operative fasting. Moreover, if this proved effective, could be used for enhancement of gastric emptying before emergency operations in non-fasting patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

November 25, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2019

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

November 17, 2018

Last Update Submit

January 13, 2019

Conditions

AnesthesiaFasting

Outcome Measures

Primary Outcomes (1)

  • Number of children who have complete gastric emptying

    Number of children who have complete gastric emptying defined as return of the antral cross-sectional area to the baseline reading

    30 minutes after ingestion of clear fluid

Secondary Outcomes (4)

  • Antral cross-sectional area corrected to the body weight

    3 hours after ingestion of clear fluid

  • Hunger satiety score

    3 hours after ingestion of clear fluid

  • Number of children who have complete gastric emptying

    60 minutes after ingestion of clear fluid

  • Number of children who have complete gastric emptying

    120 minutes after ingestion of clear fluid

Study Arms (2)

supine position

ACTIVE COMPARATOR

The children will be in the supine position after ingestion of a standard volume of clear fluid.

Other: Supine position

Semi-sitting position

EXPERIMENTAL

The children will be in the semi-sitting position after ingestion of a standard volume of clear fluid.

Other: Semi-sitting position

Interventions

Supine positionOTHER

The children will be placed in the supine position after ingestion of a standard volume of clear fluid

supine position
Semi-sitting positionOTHER

The children will be placed in the semi-sitting position after ingestion of a standard volume of clear fluid

Semi-sitting position

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 4 to 16 years of age.
  • Fasting for elective surgery.

You may not qualify if:

  • Gastrointestinal problems that may delay gastric emptying.
  • Recent abdominal operations.
  • Major systemic diseases which could impact gastric emptying.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Mohamed Hasanin

Cairo, 11432, Egypt

Location

MeSH Terms

Conditions

Fasting

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ashraf Rady, Professor

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of anesthesia and critical care

Study Record Dates

First Submitted

November 17, 2018

First Posted

November 20, 2018

Study Start

November 25, 2018

Primary Completion

January 12, 2019

Study Completion

January 13, 2019

Last Updated

January 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)