Pulmonary Function Following Hyperbaric Oxygen Therapy: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change in Percentage Predicted Forced Vital Capacity (FVC%)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to receive at least ten cycles of HBOT (for any indication)
排除标准
- •Inability to provide informed consent
结局指标
主要结局
Change in Percentage Predicted Forced Vital Capacity (FVC%)
时间窗: 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%)
时间窗: 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%)
时间窗: 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
次要结局
- 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)
研究者
Connor Brenna
Resident Physician
University of Toronto