Hyperbaric Oxygen Therapy Registry

NCT02483650 | Unknown DMC

• 1 other identifier: CDR004
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Air or Gas Embolism; Carbon Monoxide Poisoning; Clostridial Myositis and Myonecrosis (Gas Gangrene); Crush Injury, Compartment Syndrome & Other Acute Traumatic Ischemias; Decompression Sickness; Peripheral Arterial Insufficiency and Central Retinal Artery Occlusion; Severe Anemia; Intracranial Abscess; Necrotizing Soft Tissue Infections; Osteomyelitis (Refractory); Delayed Radiation Injury (Soft Tissue and Bony Necrosis); Compromised Grafts and Flaps; Acute Thermal Burn Injury; Idiopathic Sudden Sensorineural Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Outcome of problem treated with HBOT

  Counts by outcome type

  12 Months

Secondary Outcomes (2)

• Major Amputation in Wagner Grade 3, 4, or 5 Diabetic Foot Ulcers Treated with HBOT

  12 Months

• Preservation of Function with a minor amputation among patients with Wagner Grade 3, 4, or 5 Diabetic Foot Ulcers Treated with HBOT

  12 Months

Other Outcomes (2)

• Complications or Side Effects among patients undergoing Treatment with HBOT

  12 months

• Appropriate use of HBOT in patients treated for a Diabetic foot ulcer

  12 Months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients receiving Hyperbaric Oxygen Therapy for any UHMS Approved indication

You may not qualify if:

• None

Sponsors & Collaborators

• U.S. Wound Registry: lead
• Undersea and Hyperbaric Medical Society (UHMS): collaborator

MeSH Terms

Conditions

Embolism, Air; Carbon Monoxide Poisoning; Anthrax; Gas Gangrene; Crush Injuries; Compartment Syndromes; Decompression Sickness; Retinal Artery Occlusion; Anemia; Osteomyelitis

Condition Hierarchy (Ancestors)

Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Gas Poisoning; Poisoning; Chemically-Induced Disorders; Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Barotrauma; Retinal Diseases; Eye Diseases; Arterial Occlusive Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Diseases, Infectious; Bone Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 29, 2015
• Study Start: January 1, 2005
• Primary Completion: January 1, 2020
• Last Updated: May 1, 2018

Record last verified: 2018-04