Pulmonary Function After Hyperbaric Oxygen Therapy

Completed

Conditions: Oxygen Toxicity

Interventions: Device: Hyperbaric Oxygen Therapy

Registration Number: NCT05088772

Lead Sponsor: University of Toronto

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 86

Inclusion Criteria

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

Exclusion Criteria

Inability to provide informed consent

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hyperbaric Oxygen Therapy - Experimental Group	Hyperbaric Oxygen Therapy	Patients receiving hyperbaric oxygen therapy at the Hyperbaric Medicine Unit (University Health Network, Toronto, ON, Canada)

Primary Outcome Measures

Name	Time	Method
Change in Percentage Predicted Forced Vital Capacity (FVC%)	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
Change in Percentage Predicted Forced Expiratory Volume in One Second (FEV1%)	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
Change in Percentage Predicted Forced Mid-Expiratory Flow Rate (FEF25-75%)	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 Outcome Measures

Name	Time	Method
Pulmonary Complications Following Hyperbaric Oxygen Therapy	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