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Hyperbaric Oxygen Therapy Effects on Pulmonary Functions (PulmHBOT)

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ClinicalTrials.gov Identifier: NCT03754985
Recruitment Status : Completed
First Posted : November 27, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center

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).

Condition or disease Intervention/treatment
Oxygen Toxicity Hyperoxia Device: Hyperbaric oxygen therapy

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.


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Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hyperbaric Oxygen Therapy Effects on Pulmonary Functions
Actual Study Start Date : January 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Group/Cohort Intervention/treatment
Hyperbaric Oxygen Therapy
The study included participants 18 years or older, scheduled for 60 HBOT sessions for any indication.
Device: Hyperbaric 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.





Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Probability Sample
Study Population
The study included participants 18 years or older, scheduled for 60 HBOT sessions for any indication
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754985


Locations
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Israel
Amir Hadanny
Zerifin, Israel
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
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Principal Investigator: Amir Hadanny, MD Assaf-Harofeh Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT03754985     History of Changes
Other Study ID Numbers: 0024-16-ASF
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hyperoxia
Signs and Symptoms, Respiratory
Signs and Symptoms