Feasibility of Nurse-performed Gastric Ultrasound After Surgery (SKILLS-2)

September 26, 2024 updated by: Radboud University Medical Center

Feasibility of Nurse-performed Gastric Point-of-care Ultrasound to Determine Gastric Content After Gastro-intestinal and Oncologic Surgery: a Pilot Study

Gastric ultrasound is a quick and non-invasive tool to evaluate gastric content.

Emptying of gastric content can be affected after abdominal surgery leading to the inability of tolerating oral foods. Gastric content can be assessed by gastric ultrasound and nurses were recently trained to do so in healthy volunteers; however, feasibility of nurse-performed gastric ultrasound after major abdominal surgery is not investigated yet.

This study aims to investigate the feasibility of nurse-performed gastric point-of-care ultrasound after major gastro-intestinal surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6525GE
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525GE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients are selected from a surgical ward, patients recover from liver surgery, colorectal or hyperthermic intraperitoneal chemotherapy (HIPEC) surgery, pancreatic surgery, or other gastro-intestinal abdominal procedures

Description

Inclusion Criteria:

  • Adult patients (>18 years)

  • Underwent gastrointestinal surgery:

    • partial liver resection,
    • colorectal resection,
    • HIPEC,
    • pancreatic procedures including Whipple procedures for pancreatic cancer or pancreatic disorders,
    • other gastro- intestinal abdominal procedures such as resections of sarcomas, correction of herniation.
  • Obtained written informed consent.
  • Admitted for at least 3 days.

Exclusion Criteria:

  • patients with open abdominal wounds or with abdominal pain hindering adequate gastric ultrasound
  • patients with a Percutaneous Endoscopic Gastrostomy catheter

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients after gastro-intestinal surgery
Postoperative patients after gastro-intestinal surgery (e.g. liver, pancreatic, colorectal or hyperthermic intraperitoneal chemotherapy (HIPEC) surgery)
Diagnostic test: gastric ultrasonograppy
Patients will be scanned in both supine and right lateral decubitus position (RLD)s. If the antrum is visible, it will be judged if the antrum is empty in both positions or the antrum is empty in supine position and fluid apparent in RLD position suggesting a low fluid volume (<1,5 ml/Kg). The third option is fluid apparent in both supine and RLD position, suggesting a higher fluid volume (>1,5ml/Kg) and the last option is solid food in one or both positions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of gastric ultrasound in terms of practicality
Time Frame: through study completion, for 6 months
Practicality of gastric ultrasound will be measured by the length in minutes.
through study completion, for 6 months
Feasibility of gastric ultrasound in terms of usability
Time Frame: through study completion, for 6 months
The Dutch-System Usability Scale will be used to assess usability
through study completion, for 6 months
Feasibility of gastric ultrasound in terms of acceptability perceived by patients
Time Frame: through study completion, for 6 months
Acceptability will be measured by the patients' perspective towards undergoing gastric ultrasound during recovery after surgery.
through study completion, for 6 months
Feasibility of gastric ultrasound in terms of demand
Time Frame: through study completion, for 6 months
Demand will be measured by indications for gastric ultrasound and the change for successful image acquisition. Indications involve a description of clinical signs that were present during the gastric ultrasound performance. Each attempt for gastric ultrasound will be counted, afterwards adequate images will be counted. Change for succesfull image acquisition wil be calculated by adequate images divided by numbers of attemps. Both values indicate the demand according to its definition
through study completion, for 6 months
Feasibility of Gastric ultrasound in terms of nurses accuracy and nurses confidence
Time Frame: through study completion, an average of 6 months
The nurses accuracy and nurses' confidence to perform gastric ultrasound will be assessed. Accuracy will be measured by validating the ultrasound findings independently by expert sonographers and the nurses for their peers, determining inter-rater reliability.
through study completion, an average of 6 months
Feasibility of gastric ultrasound in terms of acceptability perceived by nurses
Time Frame: through study completion, for 6 months
Acceptability will be measured by the nurses' perspective towards the acceptability of gastric ultrasound. This is measured with the Theoretical Framework of Acceptability-based (TFA) questionnaire which is modified to assess the acceptability of gastric ultrasound during recovery after surgery.
through study completion, for 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Harm HJ van Noort, PhD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2024

Primary Completion (Estimated)

November 16, 2024

Study Completion (Estimated)

December 24, 2024

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2024-17217

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be stored according to hospital guidelines and shared upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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