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

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.

Study Overview

• Status: Recruiting
• Conditions: Nasogastric Tube Intubation
• Intervention / Treatment: Device: Vagal Nerve Stimulator; Device: Placebo Vagal Nerve Stimulator

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carly Riedmann, MPH; Phone Number: 412-623-4147; Email: riedmannca@upmc.edu
• Study Contact Backup: Name: Amy Monroe, MPH, MBA; Email: monroeal@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • UPMC Shadyside Hospital
      • Contact: Amy Monroe, MPH, MBA; Phone Number: 412-623-6382; Email: monroeal@upmc.edu
      • Contact: Carly Riedmann, MPH; Email: riedmannca@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jacques E. Chelly
• Investigators: Principal Investigator: Jacques E Chelly, MD, PhD, MBA, University of Pittsburgh, UPMC

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY24070152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes