Vagal Stimulator to Reduce Nasogastric Tube Use

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

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

Treatments tested in this trial

  • Vagal Nerve Stimulator
  • Placebo Vagal Nerve Stimulator

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Jacques E. Chelly

Lead sponsor

University of Pittsburgh

Sponsor institution