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OpenTrials
Completed

NCT Number: NCT03754985

Hyperbaric Oxygen Therapy Effects on Pulmonary Functions

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).

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Key information

Study type

Observational

Primary location

Amir Hadanny

Ẕerifin, Israel

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hyperbaric oxygen therapy

Device

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.

Primary outcomes

  1. forced vital capacity (FVC)

    Time frame: change within 3 months

  2. forced expiratory volume in one second (FEV1)

    Time frame: change within 3 months

  3. peak expiratory flow rate (PEF)

    Time frame: change within 3 months

  4. forced mid-expiratory flow rate (FEF25-75%)

    Time frame: change within 3 months

  5. FEV1/FVC ratio

    Time frame: change within 3 months

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Acronym: PulmHBOT

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 27, 2018
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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