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Point-of-care-ultrasoundSKILLS-2NCT06620549

Feasibility of Nurse-performed Gastric Ultrasound After Surgery

An observational study of Point-of-care-ultrasound and Gastric Ultrasonography, run by Radboud University Medical Center at 2 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
gastric ultrasonograppy
How many people
135 participants
Where
2 sitesNetherlands
Study dates
22 Apr 2024to 24 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Adult patients (>18 years)
  • Underwent gastrointestinal surgery:
  • partial liver resection,
  • colorectal resection,
  • HIPEC,
  • pancreatic procedures including Whipple procedures for pancreatic cancer or pancreatic disorders,
Show all 9Show fewer
  • other gastro- intestinal abdominal procedures such as resections of sarcomas, correction of herniation.
  • Obtained written informed consent.
  • Admitted for at least 3 days.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Harm H.J. van Noort, PhD contact

0243613438

harm.vannoort@radboudumc.nl

Netherlands2 sites, 2 recruiting

  • RadboudUMC

    Nijmegen, Gelderland, 6525GE

    Harm HJ van Noort, PhD, +31 (0)243613438, harm.vannoort@radboudumc.nl

    Recruiting

  • Radboudumc

    Nijmegen, 6525GE

    Harm H.J. van Noort, PhD, (024) 36 13438, harm.vannoort@radboudumc.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: 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.

Being tested
gastric ultrasonograppy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gastric ultrasonograppyDiagnostic test

    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.

Study groups in NCT06620549
Study groupRoleWhat they receive
Patients after gastro-intestinal surgeryPostoperative patients after gastro-intestinal surgery (e.g. liver, pancreatic, colorectal or hyperthermic intraperitoneal chemotherapy (HIPEC) surgery)
Receives: Diagnostic Test: gastric ultrasonograppy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of gastric ultrasound in terms of practicality

    Practicality of gastric ultrasound will be measured by the length in minutes.

    Measured: through study completion, for 6 months

  2. Feasibility of gastric ultrasound in terms of usability

    The Dutch-System Usability Scale will be used to assess usability

    Measured: through study completion, for 6 months

  3. Feasibility of gastric ultrasound in terms of acceptability perceived by patients

    Acceptability will be measured by the patients' perspective towards undergoing gastric ultrasound during recovery after surgery.

    Measured: through study completion, for 6 months

  4. Feasibility of gastric ultrasound in terms of demand

    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

    Measured: through study completion, for 6 months

  5. Feasibility of Gastric ultrasound in terms of nurses accuracy and nurses confidence

    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.

    Measured: through study completion, an average of 6 months

  6. Feasibility of gastric ultrasound in terms of acceptability perceived by nurses

    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.

    Measured: through study completion, for 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start22 Apr 2024
  3. Primary completion16 Nov 2024 (estimated)
  4. Study completion24 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06620549
Sponsor's protocol ID
2024-17217
Acronym
SKILLS-2
Status last verified
Apr 2024
First submitted
16 Apr 2024
Last updated
1 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data will be stored according to hospital guidelines and shared upon reasonable request

Publications

  • Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22. doi: 10.1093/bja/aeu151. Epub 2014 Jun 3.

    PubMed 24893784

  • Lamm R, Collins M, Bloom J, Joel M, Iosif L, Park D, Reny J, Schultz S, Yeo CJ, Beausang D, Schwenk ES, Costanzo C, Phillips BR. Postoperative Handheld Gastric Point-of-Care Ultrasound and Delayed Bowel Function. J Am Coll Surg. 2023 Apr 1;236(4):554-559. doi: 10.1097/XCS.0000000000000536. Epub 2023 Jan 5.

    PubMed 36602237

  • Lamm R, Bloom J, Collins M, Goldman D, Beausang D, Costanzo C, Schwenk ES, Phillips B. A Role for Gastric Point of Care Ultrasound in Postoperative Delayed Gastrointestinal Functioning. J Surg Res. 2022 Aug;276:92-99. doi: 10.1016/j.jss.2022.02.028. Epub 2022 Mar 24.

    PubMed 35339785

  • 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.

    PubMed 34924254

  • 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.

    PubMed 23703533

  • Cozza V, Barberis L, Altieri G, Donatelli M, Sganga G, La Greca A. Prediction of postoperative nausea and vomiting by point-of-care gastric ultrasound: can we improve complications and length of stay in emergency surgery? A cohort study. BMC Anesthesiol. 2021 Aug 31;21(1):211. doi: 10.1186/s12871-021-01428-0.

    PubMed 34465303

Questions about this trial

What is this clinical trial studying?

An observational study of Point-of-care-ultrasound and Gastric Ultrasonography, run by Radboud University Medical Center at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Harm H.J. van Noort, PhD (0243613438, harm.vannoort@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of gastric ultrasound in terms of practicality (time frame: through study completion, for 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06620549, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.

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