Clinical trial NCT05088772: Pulmonary Function After Hyperbaric Oxygen Therapy
Official title: Pulmonary Function Following Hyperbaric Oxygen Therapy: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxygen Toxicity
Keywords: Hyperbaric Oxygen Therapy
Pulmonary Function
Hyperoxia
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing HBOT at the investigators' large referral center, for any clinical indication.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Inability to provide informed consent

Primary outcomes:
measure: Change in Percentage Predicted Forced Expiratory Volume in One Second (FEV1%)
timeFrame: The outcome measure was evaluated at baseline (pre-HBOT) and after four weeks (20 treatments), eight weeks (40 treatments), and twelve weeks (60 treatments)
measure: Change in Percentage Predicted Forced Vital Capacity (FVC%)
timeFrame: The outcome measure was evaluated at baseline (pre-HBOT) and after four weeks (20 treatments), eight weeks (40 treatments), and twelve weeks (60 treatments)
measure: Change in Percentage Predicted Forced Mid-Expiratory Flow Rate (FEF25-75%)
timeFrame: The outcome measure was evaluated at baseline (pre-HBOT) and after four weeks (20 treatments), eight weeks (40 treatments), and twelve weeks (60 treatments)
Secondary outcomes:
measure: Pulmonary Complications Following Hyperbaric Oxygen Therapy
timeFrame: 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
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hyperbaric Medicine Unit
state: Ontario
Study officials:
affiliation: Hyperbaric Medicine Unit, University Health Network, Toronto, ON, Canada
name: Rita Katznelson, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.