The Protective Effects Of Treatment With Hyperbaric Oxygen Prior To Bypass Heart Surgery
This study has been completed.
Sponsor:
Hull and East Yorkshire Hospitals NHS Trust
Collaborator:
North of England Medical & Hyperbaric Services
Information provided by:
Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00623142
First received: February 14, 2008
Last updated: February 22, 2008
Last verified: January 2008
| Tracking Information | |||||
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| First Received Date ICMJE | February 14, 2008 | ||||
| Last Updated Date | February 22, 2008 | ||||
| Start Date ICMJE | January 2005 | ||||
| Primary Completion Date | January 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00623142 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 | The Protective Effects Of Treatment With Hyperbaric Oxygen Prior To Bypass Heart Surgery | ||||
| Official Title ICMJE | The Effects of Hyperbaric Oxygen Preconditioning On Cardiovascular Protection & Ischemic Reperfusion Injury | ||||
| Brief Summary | The purpose of this study was to determine if treating patients who have coronary heart disease with hyperbaric oxygen (HBO) prior to coronary artery bypass graft (CABG) surgery reduces injury to the heart and vascular system during and after surgery. Furthermore, this study also aims to identify some of the post CABG clinical effects of HBO treatment prior to CABG. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Hyperbaric Oxygen
100% Oxygen at 2.4 ATA for 30 minutes followed by 5 minutes break followed by 100% Oxygen at 2.4 ATA for another 30 minutes. This intervention was given about 4 to 5 hours prior to CABG
Other Name: Hyperbaric Oxygen Preconditioning |
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| Study Arm (s) |
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| Publications * |
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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 | Completed | ||||
| Enrollment ICMJE | 81 | ||||
| Completion Date | January 2008 | ||||
| Primary Completion Date | January 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00623142 | ||||
| Other Study ID Numbers ICMJE | R0047, 04/Q1104/26 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr. Jeysen Zivan Yogaratnam, Hull & East Yorkshire NHS Trust | ||||
| Study Sponsor ICMJE | Hull and East Yorkshire Hospitals NHS Trust | ||||
| Collaborators ICMJE | North of England Medical & Hyperbaric Services | ||||
| Investigators ICMJE |
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| Information Provided By | Hull and East Yorkshire Hospitals NHS Trust | ||||
| Verification Date | January 2008 | ||||
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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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