NCT06320574

Brief Summary

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

March 20, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

February 11, 2024

Last Update Submit

March 19, 2024

Conditions

Keywords

Gastric UltrasoundNursesTrainingCompetencypoint-of-care ultrasound

Outcome Measures

Primary Outcomes (1)

  • Number of required training

    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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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;
  • 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

You may not qualify if:

  • subjects who do not provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.

    PMID: 21364462BACKGROUND
  • Perlas A, Arzola C, Van de Putte P. Point-of-care gastric ultrasound and aspiration risk assessment: a narrative review. Can J Anaesth. 2018 Apr;65(4):437-448. doi: 10.1007/s12630-017-1031-9. Epub 2017 Dec 11.

    PMID: 29230709BACKGROUND
  • Perlas A, Van de Putte P, Van Houwe P, Chan VW. I-AIM framework for point-of-care gastric ultrasound. Br J Anaesth. 2016 Jan;116(1):7-11. doi: 10.1093/bja/aev113. Epub 2015 May 7. No abstract available.

    PMID: 25951832BACKGROUND
  • Lamm R, Collins M, Bloom J, Joel M, Iosif L, Park D, Reny J, Schultz S, Phillips B, Schwenk E, Costanzo C. Novice User Learning Curve for Handheld Gastric Point of Care Ultrasound Evaluations to Detect Delayed Return of Postoperative Peristalsis. Am Surg. 2023 Dec;89(12):6290-6292. doi: 10.1177/00031348231156770. Epub 2023 Feb 14. No abstract available.

    PMID: 36787243BACKGROUND
  • Arzola C, Carvalho JC, Cubillos J, Ye XY, Perlas A. Anesthesiologists' learning curves for bedside qualitative ultrasound assessment of gastric content: a cohort study. Can J Anaesth. 2013 Aug;60(8):771-9. doi: 10.1007/s12630-013-9974-y. Epub 2013 May 24.

    PMID: 23703533BACKGROUND
  • Brotfain E, Erblat A, Luft P, Elir A, Gruenbaum BF, Livshiz-Riven I, Koyfman A, Fridrich D, Koyfman L, Friger M, Grivnev A, Zlotnik A, Klein M. Nurse-performed ultrasound assessment of gastric residual volume and enteral nasogastric tube placement in the general intensive care unit. Intensive Crit Care Nurs. 2022 Apr;69:103183. doi: 10.1016/j.iccn.2021.103183. Epub 2021 Dec 16.

    PMID: 34924254BACKGROUND

Study Officials

  • Getty Huisman-de Waal, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Harm H.J. van Noort, RN, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2024

First Posted

March 20, 2024

Study Start

March 14, 2024

Primary Completion

April 20, 2024

Study Completion

August 1, 2024

Last Updated

March 20, 2024

Record last verified: 2024-02