Feasibility of Nurse-performed Gastric Ultrasound After Surgery

NCT ID: NCT06620549

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-22

Study Completion Date

2024-12-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Point-of-care-ultrasound Gastric Ultrasonography Gastric Ultrasound Gastro Intestinal Surgery Nursing Abdominal Surgeries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients after gastro-intestinal surgery

Postoperative patients after gastro-intestinal surgery (e.g. liver, pancreatic, colorectal or hyperthermic intraperitoneal chemotherapy (HIPEC) surgery)

gastric ultrasonograppy

Intervention Type DIAGNOSTIC_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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Harm HJ van Noort, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

RadboudUMC

Nijmegen, Gelderland, Netherlands

Site Status RECRUITING

Radboudumc

Nijmegen, , Netherlands

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Harm H.J. van Noort, PhD

Role: CONTACT

0243613438

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Harm HJ van Noort, PhD

Role: primary

+31 (0)243613438

Harm H.J. van Noort, PhD

Role: primary

(024) 36 13438

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24893784 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36602237 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35339785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34924254 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23703533 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34465303 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-17217

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Postoperative Oral Intake Trial
NCT00134407 COMPLETED PHASE1