Clinical trial NCT03017066: Ultrasound Assessment of Preoperative Gastric Volume in Children
Official title: Ultrasound Assessment of Gastric Volume Following Preoperative Fasting Guideline in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasting
Keywords: Ultrasonography
Child
Preoperative period
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 78
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: Intra-group difference between gastric volume measured on second and third ultrasound assessment
timeFrame: Interval between second and third ultrasound assessment, an expected average of 1 hour
Secondary outcomes:
measure: Inter-group difference in gastric volume at each time point
timeFrame: From 6 hours prior to surgery to the induction of general anesthesia, an expected average of 6 hours
measure: Perioperative incidence of nausea, vomiting, fever, and respiratory complications
timeFrame: From the induction of general anesthesia until postoperative 24 hours
measure: Degree of patient's preoperative anxiety, scored from 0 to 10, with 0 being good and 10 being bad
timeFrame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
measure: Degree of patient's preoperative hunger, scored from 0 to 10, with 0 being good and 10 being bad
timeFrame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
measure: Degree of patient's preoperative nausea, scored from 0 to 10, with 0 being good and 10 being bad
timeFrame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
measure: Degree of patient's preoperative thirst, scored from 0 to 10, with 0 being good and 10 being bad
timeFrame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
measure: Degree of patient's preoperative weakness, scored from 0 to 10, with 0 being good and 10 being bad
timeFrame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
measure: Degree of patient's preoperative irritability, scored from 0 to 10, with 0 being good and 10 being bad
timeFrame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
measure: Degree of parent's satisfaction, scored from 0 to 10, with 0 being satisfied and 10 being unsatisfied
timeFrame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
citation: 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.
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.
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.