Clinical trial NCT03754985: Hyperbaric Oxygen Therapy Effects on Pulmonary Functions
Official title: Hyperbaric Oxygen Therapy Effects on Pulmonary Functions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxygen Toxicity
Hyperoxia
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-11-27
Enrollment: 105
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study included participants 18 years or older, scheduled for 60 HBOT sessions for any indication

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.

Eligibility 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.

Primary outcomes:
measure: forced vital capacity (FVC)
timeFrame: change within 3 months
measure: forced expiratory volume in one second (FEV1)
timeFrame: change within 3 months
measure: peak expiratory flow rate (PEF)
timeFrame: change within 3 months
measure: forced mid-expiratory flow rate (FEF25-75%)
timeFrame: change within 3 months
measure: FEV1/FVC ratio
timeFrame: change within 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Amir Hadanny
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Amir Hadanny, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.