Pulmonary Function After Hyperbaric Oxygen Therapy

NCT ID: NCT05088772

Last Updated: 2024-05-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2022-10-31

Brief Summary

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Patients receiving hyperbaric oxygen therapy (HBOT) for any indication at the Hyperbaric Medicine Unit (University Health Network, Toronto, ON, Canada) from 2016-2021 were recruited to this prospective cohort study. While receiving HBOT (at 2.0-2.4 ATA, with 1-3 "air breaks", with specific treatment details determined on a case-by-case basis and directed by the clinical team), enrolled patients underwent pulmonary function testing prior to HBOT treatment and serially after each 20 completed treatment cycles.

Detailed Description

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Patients receiving hyperbaric oxygen therapy (HBOT) at the Hyperbaric Medicine Unit (University Health Network, Toronto, ON, Canada) from 2016-2021 were recruited with informed consent to this prospective cohort study. All included patients underwent HBOT in one of three monoplace chambers (Sechrist 3600H and Sechrist 4100H, Sechrist Industries Inc., Anaheim, CA, USA; PAH-S1-3200, Pan-America Hyperbarics Inc., Plano, TX, USA) or via a plastic hood in a multiplace chamber (Hyperbaric System, Fink Engineering PTY-LTD, Warana, Australia). HBOT was performed with 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 decision.

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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Oxygen Toxicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled to receive at least ten cycles of HBOT (for any indication)

Exclusion Criteria

* Inability to provide informed consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Connor Brenna

Resident Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Canada

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.

Reference Type RESULT
PMID: 37256885 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HBOT-PFT-19-5081.1

Identifier Type: -

Identifier Source: org_study_id

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