Epidrum for Thoracic Epidural Analgesia (Epidrum-Tho)
This study is currently recruiting participants.
Verified April 2013 by Hopital Foch
Sponsor:
Hopital Foch
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01597466
First received: May 5, 2012
Last updated: April 20, 2013
Last verified: April 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 5, 2012 | ||||||||
| Last Updated Date | April 20, 2013 | ||||||||
| Start Date ICMJE | April 2013 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Ease to identify the epidural space [ Time Frame: 30 minutes ] [ Designated as safety issue: No ] Number of cases having required more than 2 punctures and number of failures of the technique |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01597466 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Epidrum for Thoracic Epidural Analgesia | ||||||||
| Official Title ICMJE | A Comparison Study of Two Different Techniques for Identifying the Epidural Space in Patients Requiring Thoracic Epidural Analgesia: a Prospective Multicentric Randomized Study | ||||||||
| Brief Summary | The purpose of this study is to evaluate the use of the Epidrum device to identify the epidural space in patients requiring thoracic epidural analgesia. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Pain | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 120 | ||||||||
| Estimated Completion Date | July 2013 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01597466 | ||||||||
| Other Study ID Numbers ICMJE | 2012/01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Hopital Foch | ||||||||
| Study Sponsor ICMJE | Hopital Foch | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Hopital Foch | ||||||||
| Verification Date | April 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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