Vagal Stimulator to Reduce Nasogastric Tube Use

NCT06648759 | Recruiting FDA Device

• 1 other identifier: STUDY24070152
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Duration of use of nasogastric (NG) tube

  The duration of use of nasogastric (NG) tube will be reported as total of minutes the NG tube is placed and reported in each group as mean(SD) in minutes.

  Up to 30 days following surgery

Study Arms (2)

Vagal Nerve Stimulator Group

EXPERIMENTAL

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.

Device: Vagal Nerve Stimulator

Placebo Vagal Nerve Stimulator Group

SHAM COMPARATOR

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.

Device: Placebo Vagal Nerve Stimulator

Interventions

Vagal Nerve Stimulator DEVICE

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.

Vagal Nerve Stimulator Group

Placebo Vagal Nerve Stimulator DEVICE

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.

Placebo Vagal Nerve Stimulator Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jacques E. Chelly: lead

Study Sites (1)

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Study Officials

• Jacques E Chelly, MD, PhD, MBA

  University of Pittsburgh, UPMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carly Riedmann, MPH

CONTACT

412-623-4147; riedmannca@upmc.edu

Amy Monroe, MPH, MBA

CONTACT

monroeal@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Subjects will be 2:1 randomized to the Vagal Nerve Stimulator Group or the Placebo Group, respectively. A blinded study team member will use a standard, active device to establish the threshold of current required to stimulate the vagal nerve via an electrode placed on each side of the neck. The study device will be placed after surgery once an NG tube has been administered. This study device placement and adjustment may happen anywhere from the PACU to the hospital ward level, dependent on the NG tube placement timing, but it will be done in a private setting for confidential safeguards. According to the standard operative procedure of the vagal stimulator, this current threshold is achieved by (1) increasing the current until the patient feels the sensation, and then (2) reducing the current until the patient no longer feels the current. When this is established, a research-specific device (either active or sham, based on the randomization assignment) will be connected to the elect
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: December 4, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)