Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648759
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Vagal Stimulator to Reduce Nasogastric Tube Use
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Role of a Vagal Stimulator to Reduce the Frequency and Duration on Nasogastric Tube Following Abdominal Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None