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Completed

NCT Number: NCT05088772

Pulmonary Function After Hyperbaric Oxygen Therapy

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.

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Key information

Conditions

Oxygen Toxicity Hyperoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Sex eligibility

All sexes

Study type

Observational

Primary location

Hyperbaric Medicine Unit

Toronto, Ontario, M5G 2C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Inability to provide informed consent

Treatment and study plan

hyperbaric oxygen therapy

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.

Primary outcomes

  1. Change in Percentage Predicted Forced Expiratory Volume in One Second (FEV1%)

    Time frame: The outcome measure was evaluated at baseline (pre-HBOT) and after four weeks (20 treatments), eight weeks (40 treatments), and twelve weeks (60 treatments)

    Change from baseline FEV1% defined as the highest value selected from at least three satisfactory pulmonary function tests at each timepoint

  2. Change in Percentage Predicted Forced Vital Capacity (FVC%)

    Time frame: The outcome measure was evaluated at baseline (pre-HBOT) and after four weeks (20 treatments), eight weeks (40 treatments), and twelve weeks (60 treatments)

    Change from baseline FVC% defined as the highest value selected from at least three satisfactory pulmonary function tests at each timepoint

  3. Change in Percentage Predicted Forced Mid-Expiratory Flow Rate (FEF25-75%)

    Time frame: The outcome measure was evaluated at baseline (pre-HBOT) and after four weeks (20 treatments), eight weeks (40 treatments), and twelve weeks (60 treatments)

    Change from baseline FEF25-75% defined as the highest value selected from at least three satisfactory pulmonary function tests at each timepoint

Secondary outcomes

  1. Pulmonary Complications Following Hyperbaric Oxygen Therapy

    Time frame: From date of recruitment until the date of first documented pulmonary complication or most recent follow-up, whichever came first, assessed up to a maximum of 5 years from study recruitment

    Any recorded pulmonary complications of HBOT, including but not limited to lung barotrauma, air embolism, and pneumothorax, identified through retrospective chart review

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

Pulmonary Function Following Hyperbaric Oxygen Therapy: A Prospective Cohort Study

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Oct 22, 2021
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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