Feasibility of Nurse-performed Gastric Ultrasound After Surgery

NCT06620549 | Recruiting

• 1 other identifier: 2024-17217
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• Feasibility of gastric ultrasound in terms of practicality

  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

  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

  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

  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

  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

  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

Study Arms (1)

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

Interventions

gastric ultrasonograppy 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.

Patients after gastro-intestinal surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (2)

RadboudUMC

Nijmegen, Gelderland, 6525GE, Netherlands

RECRUITING

Radboudumc

Nijmegen, 6525GE, Netherlands

RECRUITING

Related Publications (6)

• 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.

  PMID: 24893784 BACKGROUND

• 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.

  PMID: 36602237 BACKGROUND

• 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.

  PMID: 35339785 BACKGROUND

• 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: 34924254 BACKGROUND

• 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: 23703533 BACKGROUND

• 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.

  PMID: 34465303 BACKGROUND

Study Officials

• Harm HJ van Noort, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harm H.J. van Noort, PhD

CONTACT

0243613438; harm.vannoort@radboudumc.nl

Study Design

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

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: October 1, 2024
• Study Start: April 22, 2024
• Primary Completion: November 16, 2024
• Study Completion: December 24, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-04

Locations

NL (2)