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Hyperbaric Oxygen Therapy Registry (HBOTR)
| Tracking Information | |||
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| First Received Date ICMJE | May 28, 2015 | ||
| Last Updated Date | May 18, 2016 | ||
| Start Date ICMJE | January 2005 | ||
| Estimated Primary Completion Date | January 2020 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Outcome of problem treated with HBOT [ Time Frame: 12 Months ] Counts by outcome type |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Change History | Complete list of historical versions of study NCT02483650 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 |
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| Original Other Outcome Measures ICMJE | Same as current | ||
| Descriptive Information | |||
| Brief Title ICMJE | Hyperbaric Oxygen Therapy Registry | ||
| Official Title ICMJE | The Registry of Hyperbaric Oxygen Therapy Treated Patients | ||
| Brief Summary | The purpose of the Hyperbaric Oxygen Therapy Registry (HBOTR) is to provide real world patient outcome and side effect information from electronic health records submitted to a specialty specific hyperbaric registry as part of "Stage 2 of Meaningful Use," including data provided to meet PQRS requirements via the registry's QCDR mission. Goals include understanding the value of HBOT among patients treated for a variety of conditions in relation to the frequency and severity of HBOT side effects. While randomized, controlled trials can establish the efficacy of treatments like HBOT, because they routinely exclude patients with co-morbid conditions common to those patients seen in usual clinical practice, the results of RCTs are usually non-generalizable. Real world data can be used to better understand the effectiveness of HBOT among typical patients, as well as the risks associated with treatment. |
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| Detailed Description | The goal of the Hyperbaric Oxygen Therapy Registry (HBOTR) for Wounds is to provide comparative effectiveness data for patients and to understand whether clinical practice guidelines are followed in the use of HBOT. Hyperbaric Oxygen Therapy (HBOT) is the use of oxygen at greater than one atmosphere (sea level) pressures and is administered by placing the entire patient in a pressurized vessel and having the patient breathe 100% oxygen. The minimum treatment pressure with evidence to support its use among the conditions approved by the Undersea and Hyperbaric Medical society is 2.0 atmospheres absolute (2 ATA) which is an inspired partial pressure of oxygen of approximately 1,520 mmHg. Hyperbaric treatments which provide less than 100% inspired oxygen at the treatment pressure and/or which provide an inspired partial pressure of oxygen less than 760 mmHg are not hyperbaric therapy. Topically applied oxygen is not hyperbaric oxygen therapy. Oxygen is a drug with a well-defined dose response curve as well as acute and chronic drug effects. HBOT also has side effects including oxygen toxicity to many organ systems. The physiological effects of hyperbaric oxygen therapy are well studied. Effectiveness in real world patients is the best current option to understand the role of HBOT in wound healing. Hospital based outpatient wound centers participating in the US Wound Registry agree to provide data as part of quality initiatives and to meet their Stage 2 Meaningful use criteria. The HBOTR is a subset of the USWR (Chronic Disease Registry) data. All patient data from all participating hyperbaric centers are transmitted to the USWR where data are then used as designated for benchmarking, to satisfy the requirements of PQRS for advanced practitioners, and for data needed by the UHMS to respond to governmental agencies. Data used for effectiveness research are HIPAA de-identified. |
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| Study Type ICMJE | Observational [Patient Registry] | ||
| Study Design ICMJE | Time Perspective: Prospective | ||
| Target Follow-Up Duration | 2 Months | ||
| Biospecimen | Not Provided | ||
| Sampling Method | Non-Probability Sample | ||
| Study Population | All patients seen at participating hospital based outpatient wound and hyperbaric centers where HBOT was administered. | ||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||
| Study Groups/Cohorts | Not Provided | ||
| 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 | Enrolling by invitation | ||
| Estimated Enrollment ICMJE | 5000 | ||
| Completion Date | Not Provided | ||
| Estimated Primary Completion Date | January 2020 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: |
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| Sex/Gender |
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| Ages | Child, Adult, Senior | ||
| Accepts Healthy Volunteers | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | Not Provided | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT02483650 | ||
| Other Study ID Numbers ICMJE | CDR004 | ||
| Has Data Monitoring Committee | Yes | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | U.S. Wound Registry | ||
| Study Sponsor ICMJE | U.S. Wound Registry | ||
| Collaborators ICMJE | Undersea and Hyperbaric Medical Society (UHMS) | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | U.S. Wound Registry | ||
| Verification Date | May 2016 | ||
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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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