Vagal Stimulator to Reduce Nasogastric Tube Use

ConditionNasogastric Tube Intubation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorJacques E. Chelly

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Vagal Nerve Stimulator GroupExperimental treatment 1 intervention

Group B: Placebo Vagal Nerve Stimulator GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Up to 30 days following surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jacques E. Chelly

Lead sponsor

University of Pittsburgh

Sponsor institution

Source ClinicalTrials.gov

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