MedDataX Logo

Vagal Stimulator to Reduce Nasogastric Tube Use

NCT ID: NCT06648759

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-04

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 tune can lead to a local trauma, bleeding and pain. Pain represents a major complaint among those with POI, often contributing to prolonged hospital stays.

It has been well established that bile function is modulated by the vagal nerve. Therefore, a non-invasive vagal stimulation administered post-operatively may facilitate the resolution of POI, accelerate the return to bile function and shorter the hospital length of stay following major abdominal surgery. Anecdotally, the use of a vagal nerve stimulator has been shown to avoid the placement of a NG tube.

In most cases, postoperative ileus is considered a benign and reversible complication that occurs in 10-30% of patients following abdominal surgery. The use of anesthesia, the use of opioids and anti-inflammatory drugs, hypokalemia, local inflammation, local hematoma, can all contribute to the development of a POI, and its treatment often requires the placement of a NG tube. The placement of a NG tube is not always effective if it is not positioned properly and is associated of a local trauma, misplacement of the NG tube, prolonged pain, and hospital stay. It is always very uncomfortable for the patient. Since the gastro-intestinal motility is regulated by the vagal nerve, the use of non-invasive vagal nerve stimulator may represent an interesting technique to reduce the frequency of this complications associated with the use of a nasogastric tube including local trauma, misplacement and pain on insertion, and constant pain as long as the NG tube remain in place.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nasogastric Tube Intubation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Vagal Nerve Stimulator

Intervention Type 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.

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.

Group Type SHAM_COMPARATOR

Placebo Vagal Nerve Stimulator

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jacques E. Chelly

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jacques E. Chelly

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jacques E Chelly, MD, PhD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh, UPMC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Carly Riedmann, MPH

Role: CONTACT

[email protected]
412-623-4147

Amy Monroe, MPH, MBA

Role: CONTACT

[email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Amy Monroe, MPH, MBA

Role: primary

[email protected]
412-623-6382

Carly Riedmann, MPH

Role: backup

[email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY24070152

Identifier Type: -

Identifier Source: org_study_id