Gastric Residual VolumeNCT03952260
Feasibility of 1 Hour Clear Fluid Fasting Prior to Paediatric GA
A study testing Fasting time for clear fluid prior to anaesthesia in people with Gastric Residual Volume, run by Ma Tai Jiun at 1 site in Malaysia.
Trial summary
The study is aim to investigate the appropriate fasting time for clear fluid in paediatric patients who plan for elective minor surgery. This is a randomize control trial, which patient will be selected randomly to fast for clear fluid for 1 hour or 2 hours. Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Residual Volume
- What is being tested?
- Fasting time for clear fluid prior to anaesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 May 2019to 15 Feb 2020
- 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 5 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 5-16 years old
- elective open minor surgery in ent, eye, dental surgery, general surgery and orthopaedics
Who cannot join
- Gastro-oesophageal reflux (GORD)
- renal failure
- severe cerebral palsy
- some enteropathies
- oesophageal strictures
- achalasia
Show all 10Show fewer
- diabetes mellitus with gastroparesis
- surgical contra-indications
- Emergency cases
- patients that were already intubated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Control Trial Comparing 6-4-1 Fasting Protocol Against Classical 6-4-2 Fasting Guideline for Paediatric Patients
The study is aim to investigate the appropriate fasting time for clear fluid in paediatric patients who plan for elective minor surgery.
This is a randomize control trial, which patient will be selected randomly to fast for clear fluid for 1 hour or 2 hours.
It is important to determine the gastric residual volume for paediatric age group prior to elective minor surgery in order to determine whether the difference between 1 hour fasting and 2 hour fasting for clear fluid is significant.
Read the detailed description
This study is to evaluate the latest fasting protocol that is currently adopted and recommended by United Kingdom, France and Royal Children Hospital Melbourne.
The research question is should investigator change fasting protocol for paediatric patients prior to operation.
The anaesthesia service is being studied. Participants are patients who are 5-16 years old are planned for elective minor surgery in ent, eye, dental surgery, general surgery and orthopaedics.
This study will be done in UMMC. 2 groups of patients will be recruit which consists of 50 patients each. Each of the group will be instructed to fast for clear fluid for 1 hour or 2 hours prior to surgery. Prior to induction, the amount of abdominal contents was examined using ultrasound scan. In addition, patients anxiety level prior to and 1 hour post general anaesthesia will be assess. Also, parents of patients will complete a questionnaire after the surgery to assess parental satisfaction toward anaesthesia service.
- Conditions
- Gastric Residual Volume
- Being tested
- Fasting time for clear fluid prior to anaesthesia
- Keywords
- Clear fluid fasting, residual gastric volume, paediatric anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting time for clear fluid prior to anaesthesiaOther
This study is to evaluate the latest fasting protocol that is currently adopted and recommended by United Kingdom, France and Royal Children Hospital Melbourne.
The research question is should we change our fasting protocol for paediatric patients prior to operation The anaesthesia service is being studied. Prior to induction, the amount of abdominal contents was examined using ultrasound scan. In addition, parents will complete a questionnaire after the surgery to assess anxiety level of patients before and after the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Fasting clear fluid for 1 hour prior to anaesthesia | Active comparator | Fasting clear fluid for 1 hour prior to anaesthesia Receives: Other: Fasting time for clear fluid prior to anaesthesia |
| Fasting clear fluid for 2 hours prior to anaesthesia | No intervention | Fasting clear fluid for 2 hours prior to anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric residual volume by ultrasound after application of clear fluid fasting for 1 hour versus 2 hours prior to general anaesthesia
We use ultrasound to evaluate gastric volume We scanning distal parts of the stomach-antrum in a semi-sitting or RLD position.
A linear high-frequency (e.g. 5-12 MHz) transducer can be used in leaner or paediatric patients or to obtain detailed images of the gastric wall(4-6mm).
Antral cross sectional area(CSA) can be measured by using two perpendicular diameters and the formula of the area of an ellipse: CSA=(AP×CC×π)/4 (AP=antero-posterior diameter and CC=craniocaudal diameter)
GV (ml)=27.0+14.6×right-latCSA-1.28×age(Perlas and colleagues formula)
Total gastric residual volume is then divide by body weight to get ml/kg, the lower the value the better the outcome.
Referance standard is gastric residual volume acquired through nasogastric suction using nasogastric tube.
Result of >1.5ml/kg show that patient posed risk of aspiration, result of >1ml/kg is significantly increase in this study
Measured: Prior to induction of general anaesthesia
Secondary outcomes (2)
Anxiety level of patients by short version of(mYPAS)modified Yale Preoperative Anxiety Scale after application of clear fluid fasting for 1 hour versus 2 hours prior to paediatric general anaesthesia
Total score from 22.916(minimum score= least anxiety level/total relaxation) to 100 (maximum score= maximum anxiety level/ panic attack)
Total score is obtained from 4 subscale as describe below:
- Activity (1-4) B. Vocalizations(1-6) C. Emotional expressivity(1-4) D. State of apparent arousal (1-4) Total score: Divide each item rating by the highest possible rating (i.e., 6 for the "vocalizations" item and 4 for all other items), add all of the produced values, divide by 4, and multiply by 100
Measured: Prior to induction of general anaesthesia and 1 hour post anaesthesia
Parental satisfaction by questionnaires after application of clear fluid fasting for 1 hour versus 2 hours prior to paediatric general anaesthesia
Total score from 20(minimum score= not satisfy) to 100 (maximum score= highly satisfy) Total score is obtained from 11 answer to the 11 questions
each of the answer will be score as: Strongly Agree(5 )- Agree(4 )- Neither Agree nor Disagree(3)- Disagree(2) -Strongly Disagree(1) except answers for questionnaire number 3,6,8 will be score as: Strongly Agree(1 )- Agree(2 )- Neither Agree nor Disagree(3)- Disagree(4) -Strongly Disagree(5) Total score calculation: Divide each item rating by 5, add all of the produced values, divide by 11, and multiply by 100
Measured: 2 hours to 24 hours post anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start15 May 2019
- Primary completion15 Dec 2019
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Residual VolumeStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ma Tai Jiun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ma Tai Jiun, University of Malaya
- Investigators
- Ma Tai Jiun, Dr, Principal investigator, University of MalayaIna Ismiarti binti Shariffuddin, Ass. Prof, Study chair, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952260
- Sponsor's protocol ID
- 2019211-7120
- Status last verified
- Jun 2020
- First submitted
- 4 May 2019
- Last updated
- 2 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be share because the IPD data is not particularly important in deciding the feasibility of 1 hour clear fluid fasting guideline.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial Comparing 6-4-1 Fasting Protocol Against Classical 6-4-2 Fasting Guideline for Paediatric Patients
- ClinicalTrials.gov ID
- NCT03952260
- Acronym / sponsor ID
- 2019211-7120
- Conditions
- Gastric Residual Volume
- Keywords
- Clear fluid fasting, residual gastric volume, paediatric anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ma Tai JiunUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 16 May 2019 (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 study is aim to investigate the appropriate fasting time for clear fluid in paediatric patients who plan for elective minor surgery.
This is a randomize control trial, which patient will be selected randomly to fast for clear fluid for 1 hour or 2 hours.
It is important to determine the gastric residual volume for paediatric age group prior to elective minor surgery in order to determine whether the difference between 1 hour fasting and 2 hour fasting for clear fluid is significant.
Detailed description
This study is to evaluate the latest fasting protocol that is currently adopted and recommended by United Kingdom, France and Royal Children Hospital Melbourne.
The research question is should investigator change fasting protocol for paediatric patients prior to operation.
The anaesthesia service is being studied. Participants are patients who are 5-16 years old are planned for elective minor surgery in ent, eye, dental surgery, general surgery and orthopaedics.
This study will be done in UMMC. 2 groups of patients will be recruit which consists of 50 patients each. Each of the group will be instructed to fast for clear fluid for 1 hour or 2 hours prior to surgery. Prior to induction, the amount of abdominal contents was examined using ultrasound scan. In addition, patients anxiety level prior to and 1 hour post general anaesthesia will be assess. Also, parents of patients will complete a questionnaire after the surgery to assess parental satisfaction toward anaesthesia service.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting clear fluid for 1 hour prior to anaesthesia | Active comparator | Other: Fasting time for clear fluid prior to anaesthesiaFasting clear fluid for 1 hour prior to anaesthesia |
| Fasting clear fluid for 2 hours prior to anaesthesia | No intervention | –Fasting clear fluid for 2 hours prior to anaesthesia |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 5-16 years old
- elective open minor surgery in ent, eye, dental surgery, general surgery and orthopaedics
Key exclusion criteria (10 listed)
- Gastro-oesophageal reflux (GORD)
- renal failure
- severe cerebral palsy
- some enteropathies
- oesophageal strictures
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 |
|---|---|---|
| Fasting time for clear fluid prior to anaesthesiaThis study is to evaluate the latest fasting protocol that is currently adopted and recommended by United Kingdom, France and Royal Children Hospital Melbourne. The research question is should we change our fasting protocol for paediatric patients prior to operation The anaesthesia service is being studied. Prior to induction, the amount of abdominal contents was examined using ultrasound scan. In addition, parents will complete a questionnaire after the surgery to assess anxiety level of patients before and after the surgery. | Other | Fasting clear fluid for 1 hour prior to anaesthesia |
Primary outcome
Gastric residual volume by ultrasound after application of clear fluid fasting for 1 hour versus 2 hours prior to general anaesthesia
Time frame: Prior to induction of general anaesthesia
We use ultrasound to evaluate gastric volume We scanning distal parts of the stomach-antrum in a semi-sitting or RLD position. A linear high-frequency (e.g. 5-12 MHz) transducer can be used in leaner or paediatric patients or to obtain detailed images of the gastric wall(4-6mm). Antral cross sectional area(CSA) can be measured by using two perpendicular diameters and the formula of the area of an ellipse: CSA=(AP×CC×π)/4 (AP=antero-posterior diameter and CC=craniocaudal diameter) GV (ml)=27.0+14.6×right-latCSA-1.28×age(Perlas and colleagues formula) Total gastric residual volume is then divide by body weight to get ml/kg, the lower the value the better the outcome. Referance standard is gastric residual volume acquired through nasogastric suction using nasogastric tube. Result of >1.5ml/kg show that patient posed risk of aspiration, result of >1ml/kg is significantly increase in this study
2 secondary outcomes
Anxiety level of patients by short version of(mYPAS)modified Yale Preoperative Anxiety Scale after application of clear fluid fasting for 1 hour versus 2 hours prior to paediatric general anaesthesia
Time frame: Prior to induction of general anaesthesia and 1 hour post anaesthesia
Parental satisfaction by questionnaires after application of clear fluid fasting for 1 hour versus 2 hours prior to paediatric general anaesthesia
Time frame: 2 hours to 24 hours post anaesthesia
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 2 Jun 2020.
- Individual participant dataSharing planned: No. The IPD will not be share because the IPD data is not particularly important in deciding the feasibility of 1 hour clear fluid fasting guideline.
Related trials for Gastric Residual Volume
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Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists
Upper Endoscopy, GLP1-R-related Disease
Not yet recruitingObservational study
Preoperative Gastric Volume and High-Risk Gastric Content in Patients With Type 2 Diabetes Mellitus
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Effect of Resuscitation on Gastric Emptying Using POCUS in Pediatric Trauma Patients
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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.
Ma Tai Jiun, Dr principal investigator
University of Malaya
Ina Ismiarti binti Shariffuddin, Ass. Prof study chair
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting time for clear fluid prior to anaesthesia in people with Gastric Residual Volume, run by Ma Tai Jiun at 1 site in Malaysia.
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 10 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 2 Jun 2020. 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 Malaysia. 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?
Gastric residual volume by ultrasound after application of clear fluid fasting for 1 hour versus 2 hours prior to general anaesthesia (time frame: Prior to induction of general anaesthesia). 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 2 Jun 2020.