Hyperbaric Oxygen Therapy Registry

Carbon Monoxide Poisoning Clinical Trial

— HBOTR  

Official title:

The Registry of Hyperbaric Oxygen Therapy Treated Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02483650
• Other study ID #: CDR004
• Status: Enrolling by invitation
• Start date: January 2005

Study information

• Verified date: April 2018
• Source: U.S. Wound Registry
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5000
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients receiving Hyperbaric Oxygen Therapy for any UHMS Approved indication

Exclusion Criteria:

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
U.S. Wound Registry	Undersea and Hyperbaric Medical Society (UHMS)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications or Side Effects among patients undergoing Treatment with HBOT	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
Other	Appropriate use of HBOT in patients treated for a Diabetic foot ulcer	Score in % of cases with appropriate use	12 Months
Primary	Outcome of problem treated with HBOT	Counts by outcome type	12 Months
Secondary	Major Amputation in Wagner Grade 3, 4, or 5 Diabetic Foot Ulcers Treated with HBOT	Scored in % of major amputations	12 Months
Secondary	Preservation of Function with a minor amputation among patients with Wagner Grade 3, 4, or 5 Diabetic Foot Ulcers Treated with HBOT	Scored in % of minor amputations	12 Months