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CompletedNCT04747691Updated Jun 6, 2022

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

An observational study in Postoperative Ileus, Postoperative Nausea and Postoperative Complications, sponsored by Eric Schwenk. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-06.

Sponsored by Eric Schwenk · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
22
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

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

Keywords

  • Postoperative Complications
  • Postoperative Ileus
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adult patients scheduled for colorectal surgery

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
22 participants (actual)
Target follow-up
10 Days
Patient registry
Yes

Groups and cohorts

  • 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

  • Diagnostic testBedside gastric ultrasound

    Bedside ultrasound exam of the stomach

05

What researchers measure

Primary outcomes

  1. Tolerance of diet advancement

    Includes replacement of NGT, downgrading diet

    Time frame: 0 - 14 days

Secondary outcomes

  1. Emesis

    Time frame: 0 - 14 days

  2. Time to first flatus

    Time frame: 0 - 14 days

  3. Aspiration pneumonitis

    Clinical or radiographic evidence of aspiration

    Time frame: 0 - 14 days

  4. Time to first bowel movement

    Time frame: 0 - 14 days

Other outcomes

  1. Nausea

    Time frame: 0 - 14 days

06

Study locations

1 site
  • Thomas Jefferson University Hospital
    Philadelphia, Pennsylvania 19107, United States
07

References and documents

Publications

  • 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. PubMed 30052550 ↗
  • 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. PubMed 30221339 ↗
  • 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. PubMed 27384094 ↗
  • 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. PubMed 24419159 ↗
  • 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. PubMed 8424572 ↗
  • 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. PubMed 30407319 ↗
  • 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. PubMed 26558477 ↗
  • 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. PubMed 24682277 ↗
  • 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. PubMed 24754527 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04747691
Lead sponsor
Eric Schwenk
Responsible party
Eric Schwenk (Associate Professor of Anesthesiology and Orthopedic Surgery, Thomas Jefferson University) — Sponsor-investigator
First posted
Feb 10, 2021
Start date
Feb 12, 2021
Primary completion
Jun 8, 2021
Completion
Jul 1, 2021
Last update
Jun 6, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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