FastingNCT03017066
Ultrasound Assessment of Preoperative Gastric Volume in Children
A study testing Ultrasound and General anesthesia in people with Fasting, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the gastric volume in pediatric patients who followed preoperative fasting guideline using ultrasound. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Fasting
- What is being tested?
- Ultrasound and General anesthesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jun 2017to 20 Apr 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 Up to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients scheduled for elective orthopedic, otolaryngologic, ophthalmologic, plastic, and urologic surgery under general anesthesia
Who cannot join
- History of surgery on the esophagus or stomach
- History of gastrointestinal disease
- Ambulatory surgery
- Considered inappropriate by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Assessment of Gastric Volume Following Preoperative Fasting Guideline in Pediatric Patients
The purpose of this study is to compare the gastric volume in pediatric patients who followed preoperative fasting guideline using ultrasound.
- Conditions
- Fasting
- Being tested
- Ultrasound, General anesthesia
- Keywords
- Ultrasonography, Child, Preoperative period
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Ultrasound assessment of gastric volume is performed three times; before ingestion of infant formula or carbohydrate drink; 1 hour prior to the surgery; and before induction of general anesthesia.
General anesthesiaOther
Scheduled operation under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Infant formula | Experimental | Patients were given infant formula 6 hours prior to surgery. Gastric volume was assessed before ingestion, 1 hour prior to the surgery, and before the induction of general anesthesia using ultrasound. Receives: Device: Ultrasound; Other: General anesthesia |
| Carbohydrate drink | Experimental | Patients were given carbohydrate drink 2 hours prior to surgery. Gastric volume was assessed before ingestion, 1 hour prior to the surgery, and before the induction of general anesthesia using ultrasound. Receives: Device: Ultrasound; Other: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-group difference between gastric volume measured on second and third ultrasound assessment
Measured: Interval between second and third ultrasound assessment, an expected average of 1 hour
Secondary outcomes (9)
Inter-group difference in gastric volume at each time point
Measured: From 6 hours prior to surgery to the induction of general anesthesia, an expected average of 6 hours
Perioperative incidence of nausea, vomiting, fever, and respiratory complications
Measured: From the induction of general anesthesia until postoperative 24 hours
Degree of patient's preoperative anxiety, scored from 0 to 10, with 0 being good and 10 being bad
Measured: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Degree of patient's preoperative hunger, scored from 0 to 10, with 0 being good and 10 being bad
Measured: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Degree of patient's preoperative nausea, scored from 0 to 10, with 0 being good and 10 being bad
Measured: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Degree of patient's preoperative thirst, scored from 0 to 10, with 0 being good and 10 being bad
Measured: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Degree of patient's preoperative weakness, scored from 0 to 10, with 0 being good and 10 being bad
Measured: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Degree of patient's preoperative irritability, scored from 0 to 10, with 0 being good and 10 being bad
Measured: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Degree of parent's satisfaction, scored from 0 to 10, with 0 being satisfied and 10 being unsatisfied
Measured: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start12 Jun 2017
- Primary completion20 Apr 2019
- Study completion20 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FastingStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017066
- Sponsor's protocol ID
- 1612100815
- Status last verified
- Sep 2020
- First submitted
- 5 Jan 2017
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.
PubMed 19512861Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.
PubMed 21364462Fukunaga C, Sugita M, Yamamoto T. Validity of ultrasonographic measurement of gastric volume in fasted pediatric patients without sedation. J Anesth. 2016 Oct;30(5):900-3. doi: 10.1007/s00540-016-2204-3. Epub 2016 Jun 22.
PubMed 27334390American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. No abstract available.
PubMed 21307770Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
PubMed 21712716Brady M, Kinn S, Ness V, O'Rourke K, Randhawa N, Stuart P. Preoperative fasting for preventing perioperative complications in children. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD005285. doi: 10.1002/14651858.CD005285.pub2.
PubMed 19821343Brunet-Wood K, Simons M, Evasiuk A, Mazurak V, Dicken B, Ridley D, Larsen B. Surgical fasting guidelines in children: Are we putting them into practice? J Pediatr Surg. 2016 Aug;51(8):1298-302. doi: 10.1016/j.jpedsurg.2016.04.006. Epub 2016 Apr 21.
PubMed 27166876
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Gastric Volume Following Preoperative Fasting Guideline in Pediatric Patients
- ClinicalTrials.gov ID
- NCT03017066
- Acronym / sponsor ID
- 1612100815
- Conditions
- Fasting
- Keywords
- Ultrasonography, Child, Preoperative period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 20 Apr 2019 (actual)
- Study completion
- 20 Apr 2019 (actual)
- First posted
- 11 Jan 2017 (estimated)
- 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 purpose of this study is to compare the gastric volume in pediatric patients who followed preoperative fasting guideline using ultrasound.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant formula | Experimental | Device: Ultrasound, Other: General anesthesiaPatients were given infant formula 6 hours prior to surgery. Gastric volume was assessed before ingestion, 1 hour prior to the surgery, and before the induction of general anesthesia using ultrasound. |
| Carbohydrate drink | Experimental | Device: Ultrasound, Other: General anesthesiaPatients were given carbohydrate drink 2 hours prior to surgery. Gastric volume was assessed before ingestion, 1 hour prior to the surgery, and before the induction of general anesthesia using ultrasound. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients scheduled for elective orthopedic, otolaryngologic, ophthalmologic, plastic, and urologic surgery under general anesthesia
Key exclusion criteria (4 listed)
- History of surgery on the esophagus or stomach
- History of gastrointestinal disease
- Ambulatory surgery
- Considered inappropriate by the investigator
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 |
|---|---|---|
| UltrasoundUltrasound assessment of gastric volume is performed three times; before ingestion of infant formula or carbohydrate drink; 1 hour prior to the surgery; and before induction of general anesthesia. | Device | Carbohydrate drink, Infant formula |
| General anesthesiaScheduled operation under general anesthesia | Other | Carbohydrate drink, Infant formula |
Primary outcome
Intra-group difference between gastric volume measured on second and third ultrasound assessment
Time frame: Interval between second and third ultrasound assessment, an expected average of 1 hour
9 secondary outcomes
Inter-group difference in gastric volume at each time point
Time frame: From 6 hours prior to surgery to the induction of general anesthesia, an expected average of 6 hours
Perioperative incidence of nausea, vomiting, fever, and respiratory complications
Time frame: From the induction of general anesthesia until postoperative 24 hours
Degree of patient's preoperative anxiety, scored from 0 to 10, with 0 being good and 10 being bad
Time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Degree of patient's preoperative hunger, scored from 0 to 10, with 0 being good and 10 being bad
Time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Degree of patient's preoperative nausea, scored from 0 to 10, with 0 being good and 10 being bad
Time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Degree of patient's preoperative thirst, scored from 0 to 10, with 0 being good and 10 being bad
Time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Degree of patient's preoperative weakness, scored from 0 to 10, with 0 being good and 10 being bad
Time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Degree of patient's preoperative irritability, scored from 0 to 10, with 0 being good and 10 being bad
Time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Degree of parent's satisfaction, scored from 0 to 10, with 0 being satisfied and 10 being unsatisfied
Time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
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 18 Sep 2020.
- Background: PubMed 19512861Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.
- Background: PubMed 21364462Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.
- Background: PubMed 27334390Fukunaga C, Sugita M, Yamamoto T. Validity of ultrasonographic measurement of gastric volume in fasted pediatric patients without sedation. J Anesth. 2016 Oct;30(5):900-3. doi: 10.1007/s00540-016-2204-3. Epub 2016 Jun 22.
- Background: PubMed 21307770American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. No abstract available.
- Background: PubMed 21712716Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
- Background: PubMed 19821343Brady M, Kinn S, Ness V, O'Rourke K, Randhawa N, Stuart P. Preoperative fasting for preventing perioperative complications in children. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD005285. doi: 10.1002/14651858.CD005285.pub2.
- Background: PubMed 27166876Brunet-Wood K, Simons M, Evasiuk A, Mazurak V, Dicken B, Ridley D, Larsen B. Surgical fasting guidelines in children: Are we putting them into practice? J Pediatr Surg. 2016 Aug;51(8):1298-302. doi: 10.1016/j.jpedsurg.2016.04.006. Epub 2016 Apr 21.
- 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.
Jin-Tae Kim principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound and General anesthesia in people with Fasting, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 4 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 18 Sep 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 South Korea. 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?
Intra-group difference between gastric volume measured on second and third ultrasound assessment (time frame: Interval between second and third ultrasound assessment, an expected average of 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03017066, which also lists 7 linked publications.
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 18 Sep 2020.