Study Results
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View full resultsBasic Information
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COMPLETED
86 participants
OBSERVATIONAL
2016-02-29
2022-10-31
Brief Summary
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Detailed Description
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Study participants completed pulmonary function testing (PFTs) at several intervals during their HBOT treatment: prior to the first HBOT session, and serially after every 20 subsequent treatments. PFTs were performed using a KoKo Trek USB Spirometer software and pneumotachometer (KoKo, USA), with the assistance of a trained technician and in accordance with industry norms.
Retrospectively, PFT data was collected from all enrolled patients' electronic and paper medical charts. This data included anonymized patient demographics, as well as percentage of predicted forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and forced mid-expiratory flow rates (FEF25-75). PFT values underwent statistical analysis to identify potential effects of HBOT on pulmonary function.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hyperbaric Oxygen Therapy - Experimental Group
Patients receiving hyperbaric oxygen therapy at the Hyperbaric Medicine Unit (University Health Network, Toronto, ON, Canada)
Hyperbaric Oxygen Therapy
Hyperbaric Oxygen Therapy performed at 100% oxygen at 2.0-2.4 ATA, with 1-3 "air breaks", typically at 5 sessions per week, with limited variation depending on the treatment indication and patient/clinician preference.
Interventions
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Hyperbaric Oxygen Therapy
Hyperbaric Oxygen Therapy performed at 100% oxygen at 2.0-2.4 ATA, with 1-3 "air breaks", typically at 5 sessions per week, with limited variation depending on the treatment indication and patient/clinician preference.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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University of Toronto
OTHER
Responsible Party
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Connor Brenna
Resident Physician
Principal Investigators
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Rita Katznelson, MD FRCPC
Role: PRINCIPAL_INVESTIGATOR
Hyperbaric Medicine Unit, University Health Network, Toronto, ON, Canada
Locations
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Hyperbaric Medicine Unit
Toronto, Ontario, Canada
Countries
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References
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Brenna CTA, Khan S, Djaiani G, Au D, Schiavo S, Wahaj M, Janisse R, Katznelson R. Pulmonary function following hyperbaric oxygen therapy: A longitudinal observational study. PLoS One. 2023 May 31;18(5):e0285830. doi: 10.1371/journal.pone.0285830. eCollection 2023.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HBOT-PFT-19-5081.1
Identifier Type: -
Identifier Source: org_study_id
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