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Hyperbaric Oxygen Therapy Effects on Pulmonary Functions

Hyperbaric Oxygen Therapy Effects on Pulmonary Functions

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03754985
Acronym
PulmHBOT
Enrollment
105
Registered
2018-11-27
Start date
2016-01-31
Completion date
2018-10-31
Last updated
2018-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperoxia, Oxygen Toxicity

Brief summary

Prospective analysis included patients, 18 years or older, scheduled for 60 daily HBOT sessions between 2016-2018. Each session was 90 min of 100% oxygen at 2 ATA with 5 minutes air breaks every 20 min, five days per week. Pulmonary functions,measured at baseline and after HBOT,included forced vital capacity (FVC), forced expiratory volume in one second (FEV1), peak expiratory flow rate (PEF).

Detailed description

After signing an informed consent form, the participants underwent a pulmonary function baseline evaluation. Participants were treated in a multiplace chamber (HAUX-Life-Support GmbH) for 60 daily sessions, 5 days a week. Each session consisted of 90 minutes of exposure to 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes. Participants repeated their pulmonary function evaluation after the last HBOT session. Pulmonary function Measurements of pulmonary functions were performed using the MiniSpir testing apparatus (MIR- Medical International Research, USA). The equipment was calibrated using a 3-liter syringe before performing measurements according to the manufacturer's instructions. Measurements were performed by a trained technician. The forced expiratory maneuvers were performed as recommended by the guidelines\[13\]. The forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and peak expiratory flow rate (PEF) were taken as the highest readings obtained from at least three satisfactory forced expiratory maneuvers. Mean forced mid-expiratory flow rate (FEF25-75%) and forced expiratory flow rates at 25, 50 and 75% of FVC expired (FEF25%, FEF50% and FEF75%) were taken as the best values from flow-volume loops not differing by \>5% from the highest FVC.

Interventions

DEVICEHyperbaric oxygen therapy

The study included participants 18 years or older, scheduled for 60 HBOT sessions for any indication. After signing an informed consent form, the participants underwent a pulmonary function baseline evaluation. Participants were treated in a multiplace chamber (HAUX-Life-Support GmbH) for 60 daily sessions, 5 days a week. Each session consisted of 90 minutes of exposure to 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes. Participants repeated their pulmonary function evaluation after the last HBOT session. After signing an informed consent form, the participants underwent a pulmonary function baseline evaluation. Participants were treated in a multiplace chamber (HAUX-Life-Support GmbH) for 60 daily sessions, 5 days a week. Each session consisted of 90 minutes of exposure to 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes. Participants repeated their pulmonary function evaluation after the last HBOT session.

Sponsors

Assaf-Harofeh Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Inclusion criteria

* 18 and older patients * scheduled for 60 HBOT sessions for any indication

Exclusion criteria

* Active smokers were excluded but patients who quit smoking more than six months prior to inclusion were allowed in the study. * active smoking * severe known pulmonary disease * chest pathology incompatible with HBOT * inner ear disease * claustrophobia * other neurological conditions * pregnancy * previous HBOT within six months prior to inclusion * the inability to sign informed consent.

Design outcomes

Primary

MeasureTime frame
forced vital capacity (FVC)change within 3 months
forced expiratory volume in one second (FEV1)change within 3 months
peak expiratory flow rate (PEF)change within 3 months
forced mid-expiratory flow rate (FEF25-75%)change within 3 months
FEV1/FVC ratiochange within 3 months

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026