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RECRUITING
NCT06648759
NA

Vagal Stimulator to Reduce Nasogastric Tube Use

Sponsor: Jacques E. Chelly

View on ClinicalTrials.gov

Summary

Abdominal surgery, laparoscopic or open, is frequently performed at UPMC Shadyside hospital. One of the most frequent complications following abdominal surgery is a postoperative ileus. Although postoperative ileus may be the result of obstruction or leakage, in most cases postoperative ileus (POI) is the result of local irritation because of fluid overload, exogenous opioids, neurohormonal dysfunction, gastrointestinal stretch, local bleeding and inflammation. POI usually lasts between 2 to 7 days. In most cases, a nasogastric tube (NG tube) is used to relieve that gastric pressure until the resolution of the POI. The placement of a NG tube can lead to a local trauma, bleeding and pain. Pain represents a major complaint among those with POI, often contributing to prolonged hospital stays.

Official title: The Role of a Vagal Stimulator to Reduce the Frequency and Duration on Nasogastric Tube Following Abdominal Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-12-04

Completion Date

2026-09-30

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

DEVICE

Vagal Nerve Stimulator

The vagal nerve stimulator device is a nonsignificant risk device that provides electrical impulses to the vagus nerve, located in the neck and ear regions. The device (pulse generator) and a wire lead (insulated wire) with electrodes on the end of the wire will send the electrical signals along the vagus nerve to your brainstem to activate various neurochemical coordinates.

DEVICE

Placebo Vagal Nerve Stimulator

The sham vagal nerve stimulator device is a nonsignificant risk device that mirrors that of the active stimulator but does not provide electrical impulses to the vagus nerve.

Locations (1)

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, United States