CClinicalTrials.gg
CompletedNCT03747796Updated Jan 15, 2019

The Impact of Semi-sitting Position Versus Supine Position on Gastric Emptying in Children Using Gastric Ultrasound

An interventional study of Supine position and Semi-sitting position in Anesthesia and Fasting, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2019-01-15.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
4 Years to 16 Years
Sex
All
01

Study 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.

Read the detailed description

Dealing with preoperative fasting requires a meticulous balance ensuring patient safety and lessening patient's discomfort. Although fasting is a basic requirement for avoiding pulmonary aspiration, it is sometimes associated with patient discomfort and hypoglycemia. According to the current guidelines for preoperative fasting of children, fasting is required for 2-hours, 4-hours, and 6-hours period after ingestion of water, breast milk, and infant formula respectively. Limited data is available for the effect of patient positioning on gastric emptying. A previous study had reported that gastric emptying of non-nutrient liquids was faster in the sitting position compared with the left lateral position . Another study showed similar findings after nutritive liquid and solid meals; whilst, a third study had reported that gravity has a little effect on gastric emptying.

In pediatric population the effect of posture on the duration of gastric emptying is not well investigated.

Gastric ultrasound is a valid, accurate, reproducible, non-invasive, bedside test for evaluation of the gastric volume. gastric ultrasound has been validated in adults as well as children for estimating the volume of gastric contents and evaluating gastric emptying.

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.

02

Conditions studied

  • Anesthesia
  • Fasting
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Gastrointestinal problems that may delay gastric emptying.
  • Recent abdominal operations.
  • Major systemic diseases which could impact gastric emptying.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    supine position

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

    Other: Supine position

  • Experimental
    Semi-sitting position

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

    Other: Semi-sitting position

Interventions

  • OtherSupine position

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

  • OtherSemi-sitting position

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

06

What researchers measure

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

    Time frame: 30 minutes after ingestion of clear fluid

Secondary outcomes

  1. Antral cross-sectional area corrected to the body weight

    Antral cross-sectional area divided by the body weight

    Time frame: 3 hours after ingestion of clear fluid

  2. Hunger satiety score

    A score which measures the degree of patient satiety. The score ranges from zero which is the worst value, to five which is the best value.

    Time frame: 3 hours after ingestion of clear fluid

  3. Number of children who have complete gastric emptying

    Number of children who have complete gastric emptying after 60 minutes, defined as return of the antral cross-sectional area to the baseline reading

    Time frame: 60 minutes after ingestion of clear fluid

  4. Number of children who have complete gastric emptying

    Number of children who have complete gastric emptying after 120 minutes, defined as return of the antral cross-sectional area to the baseline reading

    Time frame: 120 minutes after ingestion of clear fluid

07

Study locations

1 site
  • Ahmed Mohamed Hasanin
    Cairo, 11432, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03747796
Lead sponsor
Cairo University
Responsible party
Ahmed Hasanin (Assistant professor of anesthesia and critical care, Cairo University) — Principal investigator
First posted
Nov 20, 2018
Start date
Nov 25, 2018
Primary completion
Jan 12, 2019
Completion
Jan 13, 2019
Last update
Jan 15, 2019

Study contacts

Ashraf Rady, Professor
study director · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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