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

NCT04747691 | Completed

• 1 other identifier: 20D.1009
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Ileus; Postoperative Nausea; Postoperative Complications; Postoperative Nausea and Vomiting; Postoperative Vomiting; Aspiration Vomitus

Keywords

Postoperative Complications; Postoperative Ileus

Outcome Measures

Primary Outcomes (1)

• Tolerance of diet advancement

  Includes replacement of NGT, downgrading diet

  0 - 14 days

Secondary Outcomes (4)

• Emesis

  0 - 14 days

• Time to first flatus

  0 - 14 days

• Aspiration pneumonitis

  0 - 14 days

• Time to first bowel movement

  0 - 14 days

Other Outcomes (1)

• Nausea

  0 - 14 days

Study Arms (1)

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.

Diagnostic Test: Bedside gastric ultrasound

Interventions

Bedside gastric ultrasound DIAGNOSTIC_TEST

Bedside ultrasound exam of the stomach

Patients assessed with postoperative bedside gastric ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled for colorectal surgery

You may qualify if:

• Patients aged \> 18 years of age
• Patients undergoing colorectal surgery (both cancer and non-cancer)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eric Schwenk: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (9)

• 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.

  PMID: 30052550 BACKGROUND

• 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.

  PMID: 30221339 BACKGROUND

• 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.

  PMID: 27384094 BACKGROUND

• 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.

  PMID: 24419159 BACKGROUND

• 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.

  PMID: 8424572 BACKGROUND

• 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.

  PMID: 30407319 BACKGROUND

• 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.

  PMID: 26558477 BACKGROUND

• 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.

  PMID: 24682277 BACKGROUND

• 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.

  PMID: 24754527 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Postoperative Complications; Respiratory Aspiration of Gastric Contents

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Laryngopharyngeal Reflux; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology and Orthopedic Surgery

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: February 12, 2021
• Primary Completion: June 8, 2021
• Study Completion: July 1, 2021
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)