Assessing Gastric Motility and Distention in Postoperative Gastrointestinal Surgery Using Bedside Gastric Ultrasound: Predicting Risk of Aspiration Pneumonia, Ileus, Return of Bowel Function
NCT ID: NCT04747691
Last Updated: 2022-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
22 participants
OBSERVATIONAL
2021-02-12
2021-07-01
Brief Summary
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Detailed Description
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Inclusion Criteria:
* Patients aged \> 18 years of age
* Patients undergoing colorectal surgery (both cancer and non-cancer)
Exclusion Criteria:
* Patients \< 18 years of age
* Patients with previous gastric surgery
* Patients with inadequate or difficult baseline gastric ultrasound images
* Any other patient deemed a poor study candidate by the treating physicians
Research Design/Protocol: We will perform postoperative point-of-care ultrasound examinations in colorectal surgery patients and will record gastric volumes at set time points, including preoperative and the morning of postoperative day 1. The surgical team, who will be blinded to the results of the ultrasound exam, will make decisions to advance diet, remove nasogastric tube, and begin oral medications based on standard clinical criteria. At the completion of the study we will determine if there is any association between gastric volume on ultrasound and patient complications, such as nausea/vomiting, replacement of nasogastric tube, aspiration of gastric contents, inability to tolerate solid diet, prolonged admission/length of stay, and other clinical outcomes.
Outcomes: Our exploratory outcome measures will be tolerance of diet, replacement of NG tube, nausea/vomiting, time to flatus, aspiration pneumonia/pneumonitis, and length of stay.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients assessed with postoperative bedside gastric ultrasound
This patient population will include postoperative patients who received a gastrointestinal surgery and are being assessed with the bedside gastric ultrasound.
Bedside gastric ultrasound
Bedside ultrasound exam of the stomach
Interventions
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Bedside gastric ultrasound
Bedside ultrasound exam of the stomach
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing colorectal surgery (both cancer and non-cancer)
Exclusion Criteria
* Patients with previous gastric surgery
* Patients with difficult or poor ultrasound images at baseline
* Any patient deemed a poor candidate by the treating physicians
18 Years
ALL
Yes
Sponsors
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Eric Schwenk
OTHER
Responsible Party
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Eric Schwenk
Associate Professor of Anesthesiology and Orthopedic Surgery
Locations
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Countries
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References
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Haskins SC, Kruisselbrink R, Boublik J, Wu CL, Perlas A. Gastric Ultrasound for the Regional Anesthesiologist and Pain Specialist. Reg Anesth Pain Med. 2018 Oct;43(7):689-698. doi: 10.1097/AAP.0000000000000846.
Gola W, Domagala M, Cugowski A. Ultrasound assessment of gastric emptying and the risk of aspiration of gastric contents in the perioperative period. Anaesthesiol Intensive Ther. 2018;50(4):297-302. doi: 10.5603/AIT.a2018.0029. Epub 2018 Sep 17.
Mirbagheri N, Dunn G, Naganathan V, Suen M, Gladman MA. Normal Values and Clinical Use of Bedside Sonographic Assessment of Postoperative Gastric Emptying: A Prospective Cohort Study. Dis Colon Rectum. 2016 Aug;59(8):758-65. doi: 10.1097/DCR.0000000000000637.
Sabate S, Mazo V, Canet J. Predicting postoperative pulmonary complications: implications for outcomes and costs. Curr Opin Anaesthesiol. 2014 Apr;27(2):201-9. doi: 10.1097/ACO.0000000000000045.
Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.
Zhang X, Zheng W, Chen C, Kang X, Zheng Y, Bao F, Gan S, Zhu S. Goal-directed fluid therapy does not reduce postoperative ileus in gastrointestinal surgery: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Nov;97(45):e13097. doi: 10.1097/MD.0000000000013097.
Wolthuis AM, Bislenghi G, Fieuws S, de Buck van Overstraeten A, Boeckxstaens G, D'Hoore A. Incidence of prolonged postoperative ileus after colorectal surgery: a systematic review and meta-analysis. Colorectal Dis. 2016 Jan;18(1):O1-9. doi: 10.1111/codi.13210.
Barletta JF, Senagore AJ. Reducing the burden of postoperative ileus: evaluating and implementing an evidence-based strategy. World J Surg. 2014 Aug;38(8):1966-77. doi: 10.1007/s00268-014-2506-2.
Vather R, O'Grady G, Bissett IP, Dinning PG. Postoperative ileus: mechanisms and future directions for research. Clin Exp Pharmacol Physiol. 2014 May;41(5):358-70. doi: 10.1111/1440-1681.12220.
Other Identifiers
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20D.1009
Identifier Type: -
Identifier Source: org_study_id
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