Pulmonary Function After Hyperbaric Oxygen Therapy

Oxygen Toxicity Clinical Trial

Official title:

Pulmonary Function Following Hyperbaric Oxygen Therapy: A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05088772
• Other study ID #: HBOT-PFT-19-5081.1
• Status: Completed
• Start date: February 2016
• Est. completion date: October 2022

Study information

• Verified date: November 2022
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Inability to provide informed consent

Related Conditions & MeSH terms

• Oxygen Toxicity

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Hyperbaric Medicine Unit	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Percentage Predicted Forced Expiratory Volume in One Second (FEV1%)	The highest value selected from at least three satisfactory pulmonary function tests at each timepoint	Change from baseline FEV1% measured each month until treatment cessation (average of approximately eight weeks)
Primary	Change in Percentage Predicted Forced Vital Capacity (FVC%)	The highest value selected from at least three satisfactory pulmonary function tests at each timepoint	Change from baseline FVC% measured each month until treatment cessation (average of approximately eight weeks)
Primary	Change in Percentage Predicted Forced Mid-Expiratory Flow Rate (FEF25-75%)	The highest value selected from at least three satisfactory pulmonary function tests at each timepoint	Change from baseline FEF25-75% measured each month until treatment cessation (average of approximately eight weeks)
Secondary	Incidence of Pulmonary Complications following Hyperbaric Oxygen Therapy	Any recorded pulmonary complications of HBOT, including but not limited to lung barotrauma, air embolism, and pneumothorax, identified through retrospective chart review	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