Vagal Stimulator to Reduce Nasogastric Tube Use

Conditions

• Nasogastric Tube Intubation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Dec 4, 2024

Status verified

Dec 2025

Primary completion

Sep 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Carly Riedmann, MPH
  412-623-4147
  [email protected]
• Amy Monroe, MPH, MBA
  [email protected]

Locations (1)

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