Intra-arterial Measurement of pO2 in Walking Induced Transient Hack Profiles (Initial-VHS)

March 15, 2013 updated by: University Hospital, Angers

Intra-arterial Measurement of pO2 in Walking Induced Transient Hack ("WITH") Profiles

Confirm with invasive measurement the presence of a Walking-Induced Transient Hack (WITH) profile

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Arterial PO2 and body temperature measurements during exercise

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • walking induced transient Hack (WITH) tcpO2 profile

Exclusion Criteria:

  • rejection by patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with walking limitation
Patients with claudication and Walking-Induced Transient Hack (W.I.T.H.) tcpO2 profiles are tested on treadmill with invasive pO2 arterial sampling and body temperature recording
Other: Arterial sampling
Arterial pO2 (ABL5) Body Temperature (Vitalsens Cortemp) tcpO2 TCM400
Other Names:
  • All material is CE marked and approved for huamn use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
arterial pO2
Time Frame: 2 months (time required to organise the test)
2 months (time required to organise the test)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Study Chair: P Abraham, MD, PhD, University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

November 24, 2009

First Submitted That Met QC Criteria

November 25, 2009

First Posted (Estimate)

December 1, 2009

Study Record Updates

Last Update Posted (Estimate)

March 18, 2013

Last Update Submitted That Met QC Criteria

March 15, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PE 2009-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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