Nurses' Competence in Gastric Ultrasound (SKILLS-1)

March 19, 2024 updated by: Radboud University Medical Center

Nurses' Competence for Bedside Ultrasound Assessment of Gastric Content: a Cohort Study

The goal of this observational cohort study is to investigate gastric ultrasound skills in surgical nurses. The main question it aims to answer is:

• how much training is required for surgical nurses to obtain competency in performing gastric ultrasound.

Participants will follow a training involving

  • theoretical background using e-learning, picture library and lecture
  • practical skill development in an interactive hands-on workshop on live models directed by expert gastric ultrasonographer
  • and formative assessments during training sessions scanning healthy volunteers by participants and examiners (expert gastric ultrasonographers).

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Aims: To determine the amount of training bachelor nurses require to achieve competence in the bedside point-of-care ultrasound technique for qualitative assessment of gastric content.

Study design: prospective cohort educational study

Study population: The participants are six nurses at bachelor level with at least 1 year of experience with surgical patients. Volunteers are healthy persons without a pre-existing abnormal anatomy of the upper gastrointestinal tract.

Main study parameters/endpoints Primary outcome is the number of ultrasound examinations which is required to achieve competence in the performance of ultrasonography qualitative assessment of gastric content. The number of ultrasound assessments nurses need to achieve 90% success rate in 10 consecutive ultrasound assessments among healthy volunteers. Reference test is the ultrasound assessment of examiners experienced in (gastric) ultrasound.

Methods: The education program is developed according to relevant literature, panel discussion of a project group including relevant experts on gastric ultrasonography and nursing education.

Six nurses will follow the education program including didactic teachting and formal assessments. The didactic teaching include1) theoretical background using e-learning, picture library and lecture and 2) practical skill development in an interactive hands-on workshop on live models directed by expert gastric ultrasonographer. Formative assessments will be done by scanning healthy volunteers by participants and examiners (expert gastric ultrasonographers). Volunteers will be asked to adhere to a randomized prandial. Participants and examiners will be blinded for the prandial status of the volunteer.

Analysis: Cumulative sum scores will be estimated to determine the number of trainings that is required.

Study Type

Observational

Enrollment (Estimated)

8

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 Contact Backup

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Nurses employed at the gastro-intestinal and oncology department in the Radboudumc who underwent G-POCUS training The training goals are sufficient knowledge, skills, and attitude to achieve sufficient competence. The course will be divided into three components: 1) didactic teaching in an e-learning, study material, and picture library; 2) Interactive session consisting of a hands-on workshop by the expert sonographer and scanning of other trainees; 3) performing G-POCUS in healthy volunteers in a training environment with formal assessment.

Description

Inclusion criteria for nurses:

  • nurses with at least 1 year experience at the unit;
  • nurses with a bachelor's degree in nursing;
  • nurses with a particular interest in ultrasonography.
  • nurses without previous experience in ultrasonography;

Inclusion criteria for healthy volunteers:

  • no history of abnormal anatomy or surgery of the upper gastro-intestinal tract (previous oesophageal-, gastric-, or upper abdomen surgery, or hiatus hernia);
  • no diabetes mellitus

Exclusion criteria

• subjects who do not provide written informed consent.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of required training
Time Frame: 5 days of ultrasound assessment of 6 volunteers will be performed in 2 kind of prandial status (leading to 12 assessment per day)
Main study endpoint was the number of scans nurses require to achieve sufficient competency in gastric ultrasound assessment. Competence was defined as 90% success rate in the 10 consecutive gastric ultrasound assessments.
5 days of ultrasound assessment of 6 volunteers will be performed in 2 kind of prandial status (leading to 12 assessment per day)

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Getty Huisman-de Waal, 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 (Estimated)

March 14, 2024

Primary Completion (Estimated)

April 20, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

February 11, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-16880

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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