Clinical trial NCT06620549: Feasibility of Nurse-performed Gastric Ultrasound After Surgery
Official title: Feasibility of Nurse-performed Gastric Point-of-care Ultrasound to Determine Gastric Content After Gastro-intestinal and Oncologic Surgery: a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Point-of-care-ultrasound
Gastric Ultrasonography
Gastric Ultrasound
Gastro Intestinal Surgery
Nursing
Abdominal Surgeries
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of gastric ultrasound in terms of practicality
timeFrame: through study completion, for 6 months
measure: Feasibility of gastric ultrasound in terms of usability
timeFrame: through study completion, for 6 months
measure: Feasibility of gastric ultrasound in terms of acceptability perceived by patients
timeFrame: through study completion, for 6 months
measure: Feasibility of gastric ultrasound in terms of demand
timeFrame: through study completion, for 6 months
measure: Feasibility of Gastric ultrasound in terms of nurses accuracy and nurses confidence
timeFrame: through study completion, an average of 6 months
measure: Feasibility of gastric ultrasound in terms of acceptability perceived by nurses
timeFrame: through study completion, for 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: RadboudUMC
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
affiliation: Radboud University Medical Center
name: Harm HJ van Noort, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.