RecruitingNot ApplicableNCT06648759

Vagal Stimulator to Reduce Nasogastric Tube Use

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


Sponsor

Jacques E. Chelly

Enrollment

60 participants

Start Date

Dec 4, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Adults (18 and older) undergoing laparoscopic or open colorectal surgery, or any major abdominal surgeries at UPMC Shadyside
  • Development of post-operative ileus
  • Anticipation of a nasogastric (ng) tube being placed

Exclusion Criteria3

  • Pregnant subjects
  • Subjects who are unable to read, write, or speak English fluently
  • Subjects who have a developmental or neurological disorder and are not cognitively able to provide consent

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Interventions

DEVICEVagal 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.

DEVICEPlacebo 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

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NCT06648759