Hyperbaric Oxygen Therapy Effects on Pulmonary Functions

Completed

• Conditions: Hyperoxia; Oxygen Toxicity
• Interventions: Device: Hyperbaric oxygen therapy

• Registration Number: NCT03754985
• Lead Sponsor: 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).

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.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2018-09
• Study Completion: 2018-10
• Status Verified: 2018-11
• Study First Submitted: 2018-11-25
• Study First Submitted QC: 2018-11-25
• Last Update Submitted: 2018-11-25
• Study First Posted: 2018-11-27
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 105

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hyperbaric Oxygen Therapy	Hyperbaric oxygen therapy	The study included participants 18 years or older, scheduled for 60 HBOT sessions for any indication.

Primary Outcome Measures

Name	Time	Method
forced expiratory volume in one second (FEV1)	change within 3 months
peak expiratory flow rate (PEF)	change within 3 months
forced vital capacity (FVC)	change within 3 months
FEV1/FVC ratio	change within 3 months
forced mid-expiratory flow rate (FEF25-75%)	change within 3 months

Trial Locations

Locations (1)

Amir Hadanny; 🇮🇱 Zerifin, Israel