Assessing Gastric Motility and Distention in Postoperative Gastrointestinal Surgery Using Bedside Gastric Ultrasound: Predicting Risk of Aspiration Pneumonia, Ileus, Return of Bowel Function

Postoperative Complications Clinical Trial

Official title:

Assessing Gastric Motility and Distention in Postoperative Gastrointestinal Surgery Using Bedside Gastric Ultrasound: Predicting Risk of Aspiration Pneumonia, Ileus, Return of Bowel Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04747691
• Other study ID #: 20D.1009
• Status: Completed
• Start date: February 12, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: June 2022
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Point-of-care gastric ultrasound will be used to measure stomach contents postoperative in patients who underwent colorectal surgery. Stomach volume and status (empty or full) will be compared retrospectively to the standard clinical criteria for diet advancement to determine if stomach volume via ultrasound is associated with successful diet advancement, nausea/vomiting, nasogastric tube replacement, length of stay, and other clinical outcomes. Clinicians performing clinical care will be blinded to the ultrasound exam results.

Description:

Patient population: Patients undergoing colorectal surgery will be enrolled prospectively (both cancer and non-cancer patients).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 1, 2021
• Est. primary completion date: June 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 difficult or poor ultrasound images at baseline

• Any patient deemed a poor candidate by the treating physicians

Related Conditions & MeSH terms

• Aspiration Vomitus
• Ileus
• Nausea
• Pneumonia
• Pneumonia, Aspiration
• Postoperative Complications
• Postoperative Ileus
• Postoperative Nausea
• Postoperative Nausea and Vomiting
• Postoperative Vomiting
• Respiratory Aspiration of Gastric Contents
• Vomiting

Intervention

Diagnostic Test:
• Bedside gastric ultrasound
Bedside ultrasound exam of the stomach

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Eric Schwenk

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Sabaté 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. Review. — View Citation

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. Review. — View Citation

Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nausea		0 - 14 days
Primary	Tolerance of diet advancement	Includes replacement of NGT, downgrading diet	0 - 14 days
Secondary	Emesis		0 - 14 days
Secondary	Time to first flatus		0 - 14 days
Secondary	Aspiration pneumonitis	Clinical or radiographic evidence of aspiration	0 - 14 days
Secondary	Time to first bowel movement		0 - 14 days