Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05088772
Other study ID # HBOT-PFT-19-5081.1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2016
Est. completion date October 2022

Study information

Verified date May 2024
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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, 

References & 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. eCollect — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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 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
See also
  Status Clinical Trial Phase
Completed NCT05508308 - Automated Versus Manual Control Of Oxygen For Preterm Infants On Continuous Positive Airway Pressure In Nigeria N/A
Enrolling by invitation NCT05831228 - Effects of Pre-dive Ketone Food Products on Latency to CNS Oxygen Toxicity (Aim 2) N/A
Recruiting NCT04136717 - Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery N/A
Active, not recruiting NCT04133740 - Oxygenation Targets in Cardiac Surgery Patients - a Before-and-after Study Phase 4
Completed NCT03653325 - ORI to Reduce Hyperoxia After Out Hospital Cardiac Arrest N/A
Recruiting NCT05761756 - Oxygen Toxicity: Mechanisms in Humans N/A
Completed NCT02698020 - Optimized Oxygen Delivery During General Anesthesia in Newborn Infants N/A
Recruiting NCT05590130 - Comparison of Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation N/A
Terminated NCT03665259 - Lower Inspiratory Oxygen Fraction for Preoxygenation N/A
Completed NCT03114176 - Effects of Ketogenic Diet in Divers Breathing Enriched Air Nitrox N/A
Enrolling by invitation NCT05801120 - Effects of Pre-dive Ketone Food Products on Latency to CNS Oxygen Toxicity (Aim 1) N/A
Recruiting NCT05737407 - Lung Ultrasound Guided Choice of Best Positive End-Expiratory Pressure in Neonatal Anesthesia N/A
Recruiting NCT04802629 - Fetal Haemoglobin and Cerebral and Peripheral Oxygenation.
Completed NCT03174002 - Handling Oxygenation Targets in the Intensive Care Unit Phase 4
Recruiting NCT03937622 - Northern Survey on Therapeutic Oxygen Prescription
Completed NCT03453294 - Effect of THRIVE During Apneic Oxygenation in General Anesthesia on Biomarkers N/A
Completed NCT03754985 - Hyperbaric Oxygen Therapy Effects on Pulmonary Functions
Completed NCT03789396 - Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients
Completed NCT03625700 - Supplementary Oxygen in Surgical and Medical Wards Evaluated by 30-day Mortality
Recruiting NCT05414370 - Hyperoxia Induced Pulmonary Inflammation and Organ Injury: a Human in Vivo Model N/A