Recruiting

Vagal Stimulator

Sponsor:

Jacques E. Chelly

Code:

NCT06648759

Conditions

Nasogastric Tube Intubation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vagal Nerve Stimulator

Placebo Vagal Nerve Stimulator

Study Details

Brief 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.

Conditions

Nasogastric Tube Intubation

Study ID

NCT06648759

Start date

Dec 4, 2024

Status verified date

Dec, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vagal Nerve Stimulator Group

This arm of the study will be randomly assigned to receive the active vagal nerve stimulator device which is placed via electrodes on each side of the neck. The active device will experience two 45-minute sessions daily of vagal nerve stimulation until their Nasogastric (NG) tube is removed.

sham comparator: Placebo Vagal Nerve Stimulator Group

This arm of the study will be randomly assigned to receive a sham device that mirrors that of the active vagal nerve stimulator devices. The sham device arm will experience two 45-minute sessions daily of placebo vagal nerve stimulation until their Nasogastric (NG) tube is removed.

Interventions

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.

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.

Primary outcome measure

  • Duration of use of nasogastric (NG) tube [ Time Frame: Up to 30 days following surgery ]

Central Contacts and Locations

Central contacts

Carly Riedmann, MPH

412-623-4147riedmannca@upmc.edu

Amy Monroe, MPH, MBA

monroeal@upmc.edu

Locations

UPMC Shadyside Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Amy Monroe, MPH, MBA

412-623-6382monroeal@upmc.edu

Carly Riedmann, MPH

riedmannca@upmc.edu

More Information

Sponsor

Jacques E. Chelly

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jacques E. Chelly on 2025-12-17.