Hyperbaric Oxygen Therapy Effects on Pulmonary Functions (PulmHBOT)

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Israel

Amir Hadanny

Zerifin, Israel

Sponsors and Collaborators

Assaf-Harofeh Medical Center

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Assaf-Harofeh Medical Center
• ClinicalTrials.gov Identifier: NCT03754985
• Other Study ID Numbers: 0024-16-ASF
• First Posted: November 27, 2018
• Last Update Posted: November 27, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Hyperoxia; Signs and Symptoms, Respiratory