Pulmonary Function After Hyperbaric Oxygen Therapy

NCT05088772 | Completed Results FDA Device

• 1 other identifier: HBOT-PFT-19-5081.1
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxygen Toxicity

Keywords

Hyperbaric Oxygen Therapy; Pulmonary Function; Hyperoxia

Outcome Measures

Primary Outcomes (3)

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

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

  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 in Percentage Predicted Forced Vital Capacity (FVC%)

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

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

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

  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 (1)

• 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

Study Arms (1)

Hyperbaric Oxygen Therapy - Experimental Group

Patients receiving hyperbaric oxygen therapy at the Hyperbaric Medicine Unit (University Health Network, Toronto, ON, Canada)

Device: Hyperbaric Oxygen Therapy

Interventions

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.

Hyperbaric Oxygen Therapy - Experimental Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing HBOT at the investigators' large referral center, for any clinical indication.

You may qualify if:

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

You may not qualify if:

• Inability to provide informed consent

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Hyperbaric Medicine Unit

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

• 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.

  PMID: 37256885 RESULT

MeSH Terms

Conditions

Hyperoxia

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Connor Brenna
• Organization: University of Toronto

connor.brenna@mail.utoronto.ca

416 340 3598

Study Officials

• Rita Katznelson, MD FRCPC

  Hyperbaric Medicine Unit, University Health Network, Toronto, ON, Canada

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 22, 2021
• Study Start: February 1, 2016
• Primary Completion: June 1, 2021
• Study Completion: October 1, 2022
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)