FastingNCT03741777
Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume
A study testing Clear oral fluid in people with Fasting and Gastric Emptying, run by Boston Children's Hospital at 1 site in United States.
Trial summary
According to the American Society of Anesthesiologists (ASA) fasting guideline for patients undergoing elective surgery, the 2-hour fasting period is suggested for clear oral fluid (including water, pulp-free juice and tea or coffee without milk). Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting, Gastric Emptying
- What is being tested?
- Clear oral fluid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Feb 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA classification: I and II
- 13-17 years
- IPD cases or the first OPD case
- Scheduled for elective EGD procedure.
- All participants, families or guardians will be fluent in English.
Who cannot join
- Emergent EGD procedures
- Patients with active upper GI bleeding
- Patients who received preoperative oral medication
- Patients who are diagnosed as GERD, achalasia or suspected to have gastroparesis status such as uncontrolled diabetes or end stage kidney disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 01225
Patcharee Sriswasdi, MD
About this study
Official title: Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume Before Undergoing Elective Esophago-gastro-duodenoscopy (EGD) Procedure
According to the American Society of Anesthesiologists (ASA) fasting guideline for patients undergoing elective surgery, the 2-hour fasting period is suggested for clear oral fluid (including water, pulp-free juice and tea or coffee without milk). This guideline does not give any suggestions for proper volume of clear oral fluid intake.
This study is a prospective randomized control trials in children aged 13 through 17 years who are scheduled for an elective upper GI endoscopy procedure in the Gastroenteral Procedure Unit (GPU) at Boston Children's Hospital. The participants will be randomly assigned into one of four groups: Group 1 will consume 3 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time, Group 2 will consume 5 ml/kg, Group 3 will consume 7 ml/kg, and Group 4 will consume 10 ml/kg. The investigators plan to recruit 72 patients in each group and 288 patients for the whole study. Research team will collect patient's demographic data, vital signs, information about their EGD procedure. Then actual volume of the stomach content and acidity will be measured from the content that is suctioned from patient's stomach during upper GI endoscopy procedure.
The investigators believe that the information from this study will help establish a comprehensive NPO guideline.
Read the detailed description
The ASA and ESA practice guidelines recommend a 2-hour fasting period for clear fluid (including water, pulp-free juice and tea or coffee without milk), a 4- hour fasting period for breast milk and a 6-hour fasting period for non-human milk and solid food to reduce risks of pulmonary aspiration. While the ESA guideline suggests 3 ml/kg of clear oral fluids intake as a start point, the ASA does not suggest the allowable amount of ingested fluids/food volume.
According to the current consensus statement from the Association of Paediatric Anaesthetists of Great Britain and Ireland, the European Society of Paediatric Anaesthesiology and L'Association Des Anesthésistes-Réanimateurs Pédiatriques d'Expression Française on clear fluids fasting for elective pediatric general anesthesia in February 2018, this 3 ml/kg volume would mean patients ages 1-5 years old are allowed up to 55 ml, 6-12 years old up to 140 ml and greater than 12 years old up to 250 ml. The European consensus also suggests 1 hour clear fluid fasting for children as a practical way to reduce fasting times without increase aspiration risks.
To prevent preoperative dehydrated states which result in preoperative irritable behavior and intraoperative hypotension, patient fasting states and volume status should be optimized. Schmitz et al showed results of gastric emptying time of less than 30 minutes in healthy 6-14 years old children who had serial MRI scan every 30 minutes up to 120 minutes after drinking 7ml/kg of diluted raspberry syrup in 2011, the published clinical evidence suggested that clear fluids are absorbed to gastric volume of 1 ml/kg after 1 hour without pulmonary aspiration. Gawecka et al. also found no aspiration in ASA I and II children who were assigned to received 10ml/kg of 12.6% oral carbohydrate solution two hours before induction of anesthesia. Those studies showed no pulmonary aspiration event. However; pulmonary aspiration of gastric content is still a mainly concern for anesthesiologists when patients ingested large fluid volume. Previous studies reported incidences of aspiration range from1 to 10:10,000 cases and few cases require intensive care and respiratory support. The liberal clear fluid intake volume has been demonstrated to have similar risk of pulmonary aspiration as fasting patients.
The investigators propose a prospective randomized study on the relationship between assigned amount of clear oral fluid intake (ml/kg) and actual intra-gastric volume and pH of pediatric surgical patients. This study will be done at BCH's Gastroenterology Procedure Unit (GPU). Patients' demographic data will be obtained from charts. Patients will be randomly assigned to drink specific amount of fluid at 2 hours period before scheduled time. Patients or parents will be asked for other type, volume and time of last fluid/food intake. Actual intragastric volume and pH will be measured by the research team from the intragastric content that is removed at the beginning EGD procedures.
The investigators hope to demonstrate the relationship between volume of clear fluid intake at the 2-hour period before induction of anesthesia and actual intragastric volume which provide sufficient evidence of allowable clear fluid intake volume. Finally, the investigators want to use this study information to optimize standard fasting guidelines, to improve patients' preoperative volume status, to increase patient satisfaction and maintain patient safety.
- Conditions
- Fasting, Gastric Emptying
- Being tested
- Clear oral fluid
- Keywords
- NPO time, Gastric content
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear oral fluidOther
clear oral fluid including water, pulp-free juice and tea or coffee without milk.
| Study group | Role | What they receive |
|---|---|---|
| 3 ml/kg of clear oral fluid | Active comparator | This group of patient will consume 3 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time Receives: Other: Clear oral fluid |
| 5 ml/kg of clear oral fluid | Active comparator | This group of patient will consume 5 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time Receives: Other: Clear oral fluid |
| 7 ml/kg of clear oral fluid | Active comparator | This group of patient will consume 7 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time Receives: Other: Clear oral fluid |
| 10 ml/kg of clear oral fluid | Active comparator | This group of patient will consume 10 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time Receives: Other: Clear oral fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric volume
Actual gastric content volume (ml) suctioned out of each pediatric patient's stomach
Measured: We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hours
Secondary outcomes (2)
Gastric pH
Actual gastric acidity (pH) suctioned out of each pediatric patient's stomach
Measured: We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hours
Incidence of pulmonary aspiration
Pulmonary aspiration is defined by the presence of gastric contents in oral cavity or aspiration of gastric content into the larynx. This may cause a syndrome of progressive dyspnea, hypoxia, bronchial wheeze and patchy collapse and consolidation on chest X-ray.
Measured: We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start29 Feb 2024
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for FastingStudies of the same condition, open and under way.
- More trials run by Boston Children's 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The children included in this study will be randomly assigned into one of four groups by using randomization.org: Group 1 will consume 3 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time, Group 2 will consume 5 ml/kg, Group 3 will consume 7 ml/kg, and Group 4 will consume 10 ml/kg.
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patcharee Sriswasdi, Boston Children's Hospital
- Investigators
- Patcharee Sriswasdi, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741777
- Sponsor's protocol ID
- IRB-P00029632
- Status last verified
- Apr 2026
- First submitted
- 29 Aug 2018
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We might share IPD if it could maximize patient's benefit.
Publications
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 Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
PubMed 28045707Smith 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 21712716Maltby JR, Sutherland AD, Sale JP, Shaffer EA. Preoperative oral fluids: is a five-hour fast justified prior to elective surgery? Anesth Analg. 1986 Nov;65(11):1112-6.
PubMed 3767008Andersson H, Zaren B, Frykholm P. Low incidence of pulmonary aspiration in children allowed intake of clear fluids until called to the operating suite. Paediatr Anaesth. 2015 Aug;25(8):770-777. doi: 10.1111/pan.12667. Epub 2015 May 4.
PubMed 25940831Phillips S, Daborn AK, Hatch DJ. Preoperative fasting for paediatric anaesthesia. Br J Anaesth. 1994 Oct;73(4):529-36. doi: 10.1093/bja/73.4.529.
PubMed 7999497Dennhardt N, Beck C, Huber D, Sander B, Boehne M, Boethig D, Leffler A, Sumpelmann R. Optimized preoperative fasting times decrease ketone body concentration and stabilize mean arterial blood pressure during induction of anesthesia in children younger than 36 months: a prospective observational cohort study. Paediatr Anaesth. 2016 Aug;26(8):838-43. doi: 10.1111/pan.12943. Epub 2016 Jun 13.
PubMed 27291355Schmitz A, Kellenberger CJ, Liamlahi R, Studhalter M, Weiss M. Gastric emptying after overnight fasting and clear fluid intake: a prospective investigation using serial magnetic resonance imaging in healthy children. Br J Anaesth. 2011 Sep;107(3):425-9. doi: 10.1093/bja/aer167. Epub 2011 Jun 14.
PubMed 21676893Gawecka A, Mierzewska-Schmidt M. Tolerance of, and metabolic effects of, preoperative oral carbohydrate administration in children - a preliminary report. Anaesthesiol Intensive Ther. 2014 Apr-Jun;46(2):61-4. doi: 10.5603/AIT.2014.0013.
PubMed 24858963
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume Before Undergoing Elective Esophago-gastro-duodenoscopy (EGD) Procedure
- ClinicalTrials.gov ID
- NCT03741777
- Acronym / sponsor ID
- IRB-P00029632
- Conditions
- Fasting, Gastric Emptying
- Keywords
- NPO time, Gastric content
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 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.
According to the American Society of Anesthesiologists (ASA) fasting guideline for patients undergoing elective surgery, the 2-hour fasting period is suggested for clear oral fluid (including water, pulp-free juice and tea or coffee without milk). This guideline does not give any suggestions for proper volume of clear oral fluid intake.
This study is a prospective randomized control trials in children aged 13 through 17 years who are scheduled for an elective upper GI endoscopy procedure in the Gastroenteral Procedure Unit (GPU) at Boston Children's Hospital. The participants will be randomly assigned into one of four groups: Group 1 will consume 3 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time, Group 2 will consume 5 ml/kg, Group 3 will consume 7 ml/kg, and Group 4 will consume 10 ml/kg. The investigators plan to recruit 72 patients in each group and 288 patients for the whole study. Research team will collect patient's demographic data, vital signs, information about their EGD procedure. Then actual volume of the stomach content and acidity will be measured from the content that is suctioned from patient's stomach during upper GI endoscopy procedure.
The investigators believe that the information from this study will help establish a comprehensive NPO guideline.
Detailed description
The ASA and ESA practice guidelines recommend a 2-hour fasting period for clear fluid (including water, pulp-free juice and tea or coffee without milk), a 4- hour fasting period for breast milk and a 6-hour fasting period for non-human milk and solid food to reduce risks of pulmonary aspiration. While the ESA guideline suggests 3 ml/kg of clear oral fluids intake as a start point, the ASA does not suggest the allowable amount of ingested fluids/food volume.
According to the current consensus statement from the Association of Paediatric Anaesthetists of Great Britain and Ireland, the European Society of Paediatric Anaesthesiology and L'Association Des Anesthésistes-Réanimateurs Pédiatriques d'Expression Française on clear fluids fasting for elective pediatric general anesthesia in February 2018, this 3 ml/kg volume would mean patients ages 1-5 years old are allowed up to 55 ml, 6-12 years old up to 140 ml and greater than 12 years old up to 250 ml. The European consensus also suggests 1 hour clear fluid fasting for children as a practical way to reduce fasting times without increase aspiration risks.
To prevent preoperative dehydrated states which result in preoperative irritable behavior and intraoperative hypotension, patient fasting states and volume status should be optimized. Schmitz et al showed results of gastric emptying time of less than 30 minutes in healthy 6-14 years old children who had serial MRI scan every 30 minutes up to 120 minutes after drinking 7ml/kg of diluted raspberry syrup in 2011, the published clinical evidence suggested that clear fluids are absorbed to gastric volume of 1 ml/kg after 1 hour without pulmonary aspiration. Gawecka et al. also found no aspiration in ASA I and II children who were assigned to received 10ml/kg of 12.6% oral carbohydrate solution two hours before induction of anesthesia. Those studies showed no pulmonary aspiration event. However; pulmonary aspiration of gastric content is still a mainly concern for anesthesiologists when patients ingested large fluid volume. Previous studies reported incidences of aspiration range from1 to 10:10,000 cases and few cases require intensive care and respiratory support. The liberal clear fluid intake volume has been demonstrated to have similar risk of pulmonary aspiration as fasting patients.
The investigators propose a prospective randomized study on the relationship between assigned amount of clear oral fluid intake (ml/kg) and actual intra-gastric volume and pH of pediatric surgical patients. This study will be done at BCH's Gastroenterology Procedure Unit (GPU). Patients' demographic data will be obtained from charts. Patients will be randomly assigned to drink specific amount of fluid at 2 hours period before scheduled time. Patients or parents will be asked for other type, volume and time of last fluid/food intake. Actual intragastric volume and pH will be measured by the research team from the intragastric content that is removed at the beginning EGD procedures.
The investigators hope to demonstrate the relationship between volume of clear fluid intake at the 2-hour period before induction of anesthesia and actual intragastric volume which provide sufficient evidence of allowable clear fluid intake volume. Finally, the investigators want to use this study information to optimize standard fasting guidelines, to improve patients' preoperative volume status, to increase patient satisfaction and maintain patient safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The children included in this study will be randomly assigned into one of four groups by using randomization.org: Group 1 will consume 3 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time, Group 2 will consume 5 ml/kg, Group 3 will consume 7 ml/kg, and Group 4 will consume 10 ml/kg.
| Arm | Type | Receives |
|---|---|---|
| 3 ml/kg of clear oral fluid | Active comparator | Other: Clear oral fluidThis group of patient will consume 3 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time |
| 5 ml/kg of clear oral fluid | Active comparator | Other: Clear oral fluidThis group of patient will consume 5 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time |
| 7 ml/kg of clear oral fluid | Active comparator | Other: Clear oral fluidThis group of patient will consume 7 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time |
| 10 ml/kg of clear oral fluid | Active comparator | Other: Clear oral fluidThis group of patient will consume 10 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- ASA classification: I and II
- 13-17 years
- IPD cases or the first OPD case
- Scheduled for elective EGD procedure.
- All participants, families or guardians will be fluent in English.
Key exclusion criteria (4 listed)
- Emergent EGD procedures
- Patients with active upper GI bleeding
- Patients who received preoperative oral medication
- Patients who are diagnosed as GERD, achalasia or suspected to have gastroparesis status such as uncontrolled diabetes or end stage kidney disease.
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 |
|---|---|---|
| Clear oral fluidclear oral fluid including water, pulp-free juice and tea or coffee without milk. | Other | 10 ml/kg of clear oral fluid, 3 ml/kg of clear oral fluid, 5 ml/kg of clear oral fluid, 7 ml/kg of clear oral fluid |
Primary outcome
Gastric volume
Time frame: We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hours
Actual gastric content volume (ml) suctioned out of each pediatric patient's stomach
2 secondary outcomes
Gastric pH
Time frame: We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hours
Incidence of pulmonary aspiration
Time frame: We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 28045707Practice 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 Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. 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 3767008Maltby JR, Sutherland AD, Sale JP, Shaffer EA. Preoperative oral fluids: is a five-hour fast justified prior to elective surgery? Anesth Analg. 1986 Nov;65(11):1112-6.
- Background: PubMed 25940831Andersson H, Zaren B, Frykholm P. Low incidence of pulmonary aspiration in children allowed intake of clear fluids until called to the operating suite. Paediatr Anaesth. 2015 Aug;25(8):770-777. doi: 10.1111/pan.12667. Epub 2015 May 4.
- Background: PubMed 7999497Phillips S, Daborn AK, Hatch DJ. Preoperative fasting for paediatric anaesthesia. Br J Anaesth. 1994 Oct;73(4):529-36. doi: 10.1093/bja/73.4.529.
- Background: PubMed 27291355Dennhardt N, Beck C, Huber D, Sander B, Boehne M, Boethig D, Leffler A, Sumpelmann R. Optimized preoperative fasting times decrease ketone body concentration and stabilize mean arterial blood pressure during induction of anesthesia in children younger than 36 months: a prospective observational cohort study. Paediatr Anaesth. 2016 Aug;26(8):838-43. doi: 10.1111/pan.12943. Epub 2016 Jun 13.
- Background: PubMed 21676893Schmitz A, Kellenberger CJ, Liamlahi R, Studhalter M, Weiss M. Gastric emptying after overnight fasting and clear fluid intake: a prospective investigation using serial magnetic resonance imaging in healthy children. Br J Anaesth. 2011 Sep;107(3):425-9. doi: 10.1093/bja/aer167. Epub 2011 Jun 14.
- Background: PubMed 24858963Gawecka A, Mierzewska-Schmidt M. Tolerance of, and metabolic effects of, preoperative oral carbohydrate administration in children - a preliminary report. Anaesthesiol Intensive Ther. 2014 Apr-Jun;46(2):61-4. doi: 10.5603/AIT.2014.0013.
- Individual participant dataSharing planned: Undecided. We might share IPD if it could maximize patient's benefit.
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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.
Patcharee Sriswasdi, MD, MPH principal investigator
Boston Children's 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 Clear oral fluid in people with Fasting and Gastric Emptying, run by Boston Children's Hospital at 1 site in United States.
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 5 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: looking for participants now, as of the sponsor's last update on 24 Apr 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sirirat Rattanaarpa, MD (857-218-8020, sirirat.rattanaarpa@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric volume (time frame: We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hours). 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 NCT03741777, which also lists 8 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 24 Apr 2026.