Hyperbaric Oxygen Therapy Registry (HBOTR)

April 30, 2018 updated by: U.S. Wound Registry

The Registry of Hyperbaric Oxygen Therapy Treated Patients

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

5000

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients seen at participating hospital based outpatient wound and hyperbaric centers where HBOT was administered.

Description

Inclusion Criteria:

  • Patients receiving Hyperbaric Oxygen Therapy for any UHMS Approved indication

Exclusion Criteria:

  • None

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome of problem treated with HBOT
Time Frame: 12 Months
Counts by outcome type
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Amputation in Wagner Grade 3, 4, or 5 Diabetic Foot Ulcers Treated with HBOT
Time Frame: 12 Months
Scored in % of major amputations
12 Months
Preservation of Function with a minor amputation among patients with Wagner Grade 3, 4, or 5 Diabetic Foot Ulcers Treated with HBOT
Time Frame: 12 Months
Scored in % of minor amputations
12 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications or Side Effects among patients undergoing Treatment with HBOT
Time Frame: 12 months
Scores in % of: otic barotrauma, other barotrauma, central nervous system oxygen toxicity, confinement anxiety, pneumothorax, sudden respiratory distress, visual acuity changes, low blood sugar, and pulmonary oxygen toxicity.
12 months
Appropriate use of HBOT in patients treated for a Diabetic foot ulcer
Time Frame: 12 Months
Score in % of cases with appropriate use
12 Months

Collaborators and Investigators

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

Sponsor

U.S. Wound Registry

Collaborators

Undersea and Hyperbaric Medical Society (UHMS)

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 (Actual)

January 1, 2005

Primary Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

June 24, 2015

First Posted (Estimate)

June 29, 2015

Study Record Updates

Last Update Posted (Actual)

May 1, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR004

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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