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

Sponsor
Eric Schwenk (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04747691
Collaborator
(none)
22
Enrollment
1
Location
10.6
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
22 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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
Actual Study Start Date :
Feb 12, 2021
Actual Primary Completion Date :
Jun 8, 2021
Anticipated Study Completion Date :
Jan 1, 2022

Arms and Interventions

ArmIntervention/Treatment
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
Bedside ultrasound exam of the stomach

Outcome Measures

Primary Outcome Measures

  1. Tolerance of diet advancement [0 - 14 days]

    Includes replacement of NGT, downgrading diet

Secondary Outcome Measures

  1. Emesis [0 - 14 days]

  2. Time to first flatus [0 - 14 days]

  3. Aspiration pneumonitis [0 - 14 days]

    Clinical or radiographic evidence of aspiration

  4. Time to first bowel movement [0 - 14 days]

Other Outcome Measures

  1. Nausea [0 - 14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Thomas Jefferson University HospitalPhiladelphiaPennsylvaniaUnited States19107

Sponsors and Collaborators

  • Eric Schwenk

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Eric Schwenk, Associate Professor of Anesthesiology and Orthopedic Surgery, Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT04747691
Other Study ID Numbers:
  • 20D.1009
First Posted:
Feb 10, 2021
Last Update Posted:
Oct 5, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eric Schwenk, Associate Professor of Anesthesiology and Orthopedic Surgery, Thomas Jefferson University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2021