The Role of a Vagal Stimulator to Reduce the Frequency and Duration on Nasogastric Tube Following Abdominal Surgery

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
UPMC Shadyside Hospital
RECRUITING
Pittsburgh
Contact Information
Primary
Carly Riedmann, MPH
riedmannca@upmc.edu
412-623-4147
Backup
Amy Monroe, MPH, MBA
monroeal@upmc.edu
Time Frame
Start Date: 2024-12-04
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Jacques E. Chelly

This content was sourced from clinicaltrials.gov