Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500851
Status:
COMPLETED
Last Update Posted:
2010-11-30
First Post:
2007-07-12
Brief Title:
Evaluation of Jejunal Placement of Enteral Feeding Tubes
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients Endoscopic Versus Electromagnetic Method CORTRAK
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is the evaluation of the success rate of jejunal tube placement comparing the endoscopic versus the electromagnetic method in a comparative ICU patient population The investigators hypothesized that success rate of the electromagnetic jejunal tube placement will be lower than the success rate of the endoscopic method
Detailed Description:
Clinical studies have shown that up to 628 of patients receiving EN have gastrointestinal complications like high gastric residuals 200ml vomiting abdominal distension and regurgitation These complications lead to interruptions of the EN which result in a low caloric intake of the patient
In order to avoid at least some of these complications the ACCP consensus statement recommends small bowel feeding if gastric residual volumes of 150ml or higher occur The Canadian clinical practice guidelines recommend acceptance of gastric residual volumes up to 250 ml use of prokinetic agents and jejunal feeding for patients who are at high risk for intolerance of EN on inotropes sedatives paralytic agents When gastric enteral nutrition is insufficient despite acceptance of high gastric residual volumes and use of prokinetic agents small bowel feeding is the best method to nevertheless feed the patient enterally because it is associated with a significant decrease of reflux a reduced risk of aspiration and an adequate caloric intake
For small bowel feeding the placement of a jejunal feeding tube is necessary There are several possibilities to place the tube in the small bowel An excellent method still is endoscopy which has a success rate up to 98 and moreover allows an evaluation of the upper GI-tract concerning pathologies However it is a rather time consuming procedure which is of limited availability and requires trained staff As more simple alternatives unguided tubes and their placement in the small bowel were tested and showed success rates up to 75 only One of these alternatives is a jejunal feeding tube which is placed using an electromagnetic sensing technique to visualize the placement process on a bedside monitor CORTRAK The aim of this study is the evaluation of the success rate of jejunal tube placement comparing the endoscopic versus the electromagnetic method in a comparative ICU patient population
In order to avoid at least some of these complications the ACCP consensus statement recommends small bowel feeding if gastric residual volumes of 150ml or higher occur The Canadian clinical practice guidelines recommend acceptance of gastric residual volumes up to 250 ml use of prokinetic agents and jejunal feeding for patients who are at high risk for intolerance of EN on inotropes sedatives paralytic agents When gastric enteral nutrition is insufficient despite acceptance of high gastric residual volumes and use of prokinetic agents small bowel feeding is the best method to nevertheless feed the patient enterally because it is associated with a significant decrease of reflux a reduced risk of aspiration and an adequate caloric intake
For small bowel feeding the placement of a jejunal feeding tube is necessary There are several possibilities to place the tube in the small bowel An excellent method still is endoscopy which has a success rate up to 98 and moreover allows an evaluation of the upper GI-tract concerning pathologies However it is a rather time consuming procedure which is of limited availability and requires trained staff As more simple alternatives unguided tubes and their placement in the small bowel were tested and showed success rates up to 75 only One of these alternatives is a jejunal feeding tube which is placed using an electromagnetic sensing technique to visualize the placement process on a bedside monitor CORTRAK The aim of this study is the evaluation of the success rate of jejunal tube placement comparing the endoscopic versus the electromagnetic method in a comparative ICU patient population
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