Fasting Clinical Trial
Official title:
Ultrasound Assessment of Gastric Volume Following Preoperative Fasting Guideline in Pediatric Patients
NCT number | NCT03017066 |
Other study ID # | 1612100815 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 12, 2017 |
Est. completion date | April 20, 2019 |
Verified date | September 2020 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the gastric volume in pediatric patients who followed preoperative fasting guideline using ultrasound.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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
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 |
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