NCT03017066

Brief Summary

The purpose of this study is to compare the gastric volume in pediatric patients who followed preoperative fasting guideline using ultrasound.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

June 12, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2019

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

1.9 years

First QC Date

January 5, 2017

Last Update Submit

September 17, 2020

Conditions

Fasting

Keywords

UltrasonographyChildPreoperative period

Outcome Measures

Primary Outcomes (1)

  • Intra-group difference between gastric volume measured on second and third ultrasound assessment

    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

    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

    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

    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

    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

    From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours

  • +4 more secondary outcomes

Study Arms (2)

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.

Device: UltrasoundOther: 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.

Device: UltrasoundOther: General anesthesia

Interventions

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.

Carbohydrate drinkInfant formula
General anesthesiaOTHER

Scheduled operation under general anesthesia

Carbohydrate drinkInfant formula

Eligibility Criteria

AgeUp to 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- Pediatric patients scheduled for elective orthopedic, otolaryngologic, ophthalmologic, plastic, and urologic surgery under general anesthesia

You may not qualify if:

  • History of surgery on the esophagus or stomach
  • History of gastrointestinal disease
  • Ambulatory surgery
  • Considered inappropriate by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (7)

  • 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.

    PMID: 19512861BACKGROUND

  • Bouvet 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.

    PMID: 21364462BACKGROUND

  • Fukunaga 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.

    PMID: 27334390BACKGROUND

  • American 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.

    PMID: 21307770BACKGROUND

  • Smith 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.

    PMID: 21712716BACKGROUND

  • Brady 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.

    PMID: 19821343BACKGROUND

  • Brunet-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.

    PMID: 27166876BACKGROUND

MeSH Terms

Conditions

Fasting

Interventions

UltrasonographyAnesthesia, General

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAnesthesiaAnesthesia and Analgesia

Study Officials

  • Jin-Tae Kim

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 11, 2017

Study Start

June 12, 2017

Primary Completion

April 20, 2019

Study Completion

April 20, 2019

Last Updated

September 18, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)