Hyperbaric Oxygen Therapy Effects on Pulmonary Functions (PulmHBOT)

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).

Study Overview

• Status: Completed
• Conditions: Hyperoxia; Oxygen Toxicity
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Israel
  • Zerifin, Israel
    • Amir Hadanny

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The study included participants 18 years or older, scheduled for 60 HBOT sessions for any indication

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 ratio	change within 3 months

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Investigators: Principal Investigator: Amir Hadanny, MD, Assaf-Harofeh Medical Center

Publications and helpful links

General Publications

• Hadanny A, Zubari T, Tamir-Adler L, Bechor Y, Fishlev G, Lang E, Polak N, Bergan J, Friedman M, Efrati S. Hyperbaric oxygen therapy effects on pulmonary functions: a prospective cohort study. BMC Pulm Med. 2019 Aug 13;19(1):148. doi: 10.1186/s12890-019-0893-8.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): September 1, 2018
• Study Completion (ACTUAL): October 1, 2018

Study Registration Dates

• First Submitted: November 25, 2018
• First Submitted That Met QC Criteria: November 25, 2018
• First Posted (ACTUAL): November 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 25, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hyperoxia
• Other Study ID Numbers: 0024-16-ASF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No