Ultrasound Assessment of Preoperative Gastric Volume in Children

Fasting Clinical Trial

Official title:

Ultrasound Assessment of Gastric Volume Following Preoperative Fasting Guideline in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03017066
• Other study ID #: 1612100815
• Status: Completed
• Phase: N/A
• Start date: June 12, 2017
• Est. completion date: April 20, 2019

Study information

• Verified date: September 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 20, 2019
• Est. primary completion date: April 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• History of surgery on the esophagus or stomach

• History of gastrointestinal disease

• Ambulatory surgery

• Considered inappropriate by the investigator

Related Conditions & MeSH terms

• Fasting

Intervention

Device:
• Ultrasound
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.

Other:
• General anesthesia
Scheduled operation under general anesthesia

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Søreide 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Perioperative incidence of nausea, vomiting, fever, and respiratory complications		From the induction of general anesthesia until postoperative 24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	Degree of patient's preoperative thirst, 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
Secondary	Degree of patient's preoperative weakness, 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
Secondary	Degree of patient's preoperative irritability, 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
Secondary	Degree of parent's satisfaction, scored from 0 to 10, with 0 being satisfied and 10 being unsatisfied		From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours