NCT00500851

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

November 30, 2010

Status Verified

February 1, 2009

Enrollment Period

1.7 years

First QC Date

July 12, 2007

Last Update Submit

November 29, 2010

Conditions

Critical IllnessTube Feeding

Keywords

critical illnessenteral nutritiongastrointestinal intubation

Outcome Measures

Primary Outcomes (1)

  • Success rate of jejunal placement

    24h

Secondary Outcomes (1)

  • Time from initiation of tube placement till correct jejunal placement, time of tube in correct jejunal position, complications of placement

    ICU-stay

Study Arms (2)

1

ACTIVE COMPARATOR

In case of meeting clinical criteria for jejunal feeding, tubes are placed using CORTRAK (electromagnetic imaging).

Device: Electromagnetic imaging for jejunal tube placement (CORTRAK)

2

ACTIVE COMPARATOR

Endoscopic placement of jejunal feeding tubes fulfilling clinical indication for jejunal feeding.

Device: Endoscopy

Interventions

Electromagnetic imaging for jejunal tube placement (CORTRAK)DEVICE

Jejunal feeding tubes are placed using electromagnetic imaging (CORTRAK)

Also known as: CORTRAK
1
EndoscopyDEVICE

Endoscopic placement of jejunal feeding tubes

Also known as: Endoscopy (Olympus), FREKA Trelumina
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intolerance of intragastric feeding (high gastric residual volumes (≥250ml)and/or repeated vomiting)
  • Clinical indication of jejunal feeding

You may not qualify if:

  • Patients not fulfilling clinical indication of jejunal feeding or contraindications for jejunal feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna, Department of Medicine III, ICU

Vienna, 1090, Austria

Location

Related Publications (1)

  • Holzinger U, Brunner R, Miehsler W, Herkner H, Kitzberger R, Fuhrmann V, Metnitz PG, Kamolz LP, Madl C. Jejunal tube placement in critically ill patients: A prospective, randomized trial comparing the endoscopic technique with the electromagnetically visualized method. Crit Care Med. 2011 Jan;39(1):73-7. doi: 10.1097/CCM.0b013e3181fb7b5f.

    PMID: 21037470DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ulrike Holzinger, MD

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 12, 2007

First Posted

July 13, 2007

Study Start

May 1, 2007

Primary Completion

January 1, 2009

Study Completion

February 1, 2009

Last Updated

November 30, 2010

Record last verified: 2009-02

Locations

AU(1)