AnesthesiaNCT03747796
The Impact of Semi-sitting Position Versus Supine Position on Gastric Emptying in Children Using Gastric Ultrasound
A study testing Supine position and Semi-sitting position in people with Anesthesia and Fasting, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Anesthesia, Fasting
- What is being tested?
- Supine position and Semi-sitting position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Nov 2018to 13 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 4 to 16 years of age.
- Fasting for elective surgery.
Who cannot join
- Gastrointestinal problems that may delay gastric emptying.
- Recent abdominal operations.
- Major systemic diseases which could impact gastric emptying.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of Semi-sitting Position Versus Supine Position on Gastric Emptying in Children Using Gastric Ultrasound: a Randomized Controlled Trial
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.
- Conditions
- Anesthesia, Fasting
- Being tested
- Supine position, Semi-sitting position
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine positionOther
The children will be placed in the supine position after ingestion of a standard volume of clear fluid
Semi-sitting positionOther
The children will be placed in the semi-sitting position after ingestion of a standard volume of clear fluid
| Study group | Role | What they receive |
|---|---|---|
| supine position | Active comparator | The children will be in the supine position after ingestion of a standard volume of clear fluid. Receives: 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. Receives: Other: Semi-sitting position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes after ingestion of clear fluid
Secondary outcomes (4)
Antral cross-sectional area corrected to the body weight
Antral cross-sectional area divided by the body weight
Measured: 3 hours after ingestion of clear fluid
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.
Measured: 3 hours after ingestion of clear fluid
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
Measured: 60 minutes after ingestion of clear fluid
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
Measured: 120 minutes after ingestion of clear fluid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start25 Nov 2018
- Primary completion12 Jan 2019
- Study completion13 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Ashraf Rady, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747796
- Sponsor's protocol ID
- N-92-2018
- Status last verified
- Jan 2019
- First submitted
- 17 Nov 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Semi-sitting Position Versus Supine Position on Gastric Emptying in Children Using Gastric Ultrasound: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03747796
- Acronym / sponsor ID
- N-92-2018
- Conditions
- Anesthesia, Fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Nov 2018 (actual)
- Primary completion
- 12 Jan 2019 (actual)
- Study completion
- 13 Jan 2019 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supine position | Active comparator | Other: Supine positionThe children will be in the supine position after ingestion of a standard volume of clear fluid. |
| Semi-sitting position | Experimental | Other: Semi-sitting positionThe children will be in the semi-sitting position after ingestion of a standard volume of clear fluid. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children 4 to 16 years of age.
- Fasting for elective surgery.
Key exclusion criteria (3 listed)
- Gastrointestinal problems that may delay gastric emptying.
- Recent abdominal operations.
- Major systemic diseases which could impact gastric emptying.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supine positionThe children will be placed in the supine position after ingestion of a standard volume of clear fluid | Other | supine position |
| Semi-sitting positionThe children will be placed in the semi-sitting position after ingestion of a standard volume of clear fluid | Other | Semi-sitting position |
Primary outcome
Number of children who have complete gastric emptying
Time frame: 30 minutes after ingestion of clear fluid
Number of children who have complete gastric emptying defined as return of the antral cross-sectional area to the baseline reading
4 secondary outcomes
Antral cross-sectional area corrected to the body weight
Time frame: 3 hours after ingestion of clear fluid
Hunger satiety score
Time frame: 3 hours after ingestion of clear fluid
Number of children who have complete gastric emptying
Time frame: 60 minutes after ingestion of clear fluid
Number of children who have complete gastric emptying
Time frame: 120 minutes after ingestion of clear fluid
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashraf Rady, Professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine position and Semi-sitting position in people with Anesthesia and Fasting, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of children who have complete gastric emptying (time frame: 30 minutes after ingestion of clear fluid). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.