---
title: Pulmonary Function After Hyperbaric Oxygen Therapy
nct_id: NCT05088772
overall_status: COMPLETED
sponsor: University of Toronto
study_type: OBSERVATIONAL
primary_condition: Oxygen Toxicity
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05088772.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05088772"
ct_last_update_post_date: 2024-05-16
last_seen_at: "2026-05-12T06:26:31.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Pulmonary Function After Hyperbaric Oxygen Therapy

**Official Title:** Pulmonary Function Following Hyperbaric Oxygen Therapy: A Prospective Cohort Study

**NCT ID:** [NCT05088772](https://clinicaltrials.gov/study/NCT05088772)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 86
- **Lead Sponsor:** University of Toronto
- **Conditions:** Oxygen Toxicity
- **Start Date:** 2016-02
- **Completion Date:** 2022-10
- **CT.gov Last Update:** 2024-05-16

## 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

- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

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

Exclusion Criteria:

* Inability to provide informed consent
```

## Arms

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

## 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.

## Primary Outcomes

- **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
- **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
- **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

- **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)_

## Locations (1)

- Hyperbaric Medicine Unit, Toronto, Ontario, Canada

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hyperbaric medicine unit|toronto|ontario|canada` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT05088772*  
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