NCT03754985

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

2.7 years

First QC Date

November 25, 2018

Last Update Submit

November 25, 2018

Conditions

Oxygen ToxicityHyperoxia

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

Hyperbaric Oxygen Therapy

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

Device: Hyperbaric oxygen therapy

Interventions

Hyperbaric oxygen therapyDEVICE

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.

Hyperbaric Oxygen Therapy

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • and older patients
  • scheduled for 60 HBOT sessions for any indication

You may not qualify if:

  • active smoking
  • severe known pulmonary disease
  • chest pathology incompatible with HBOT
  • inner ear disease
  • claustrophobia
  • other neurological conditions
  • pregnancy
  • the inability to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amir Hadanny

Ẕerifin, Israel

Location

Related Publications (1)

  • 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.

    PMID: 31409407DERIVED

MeSH Terms

Conditions

Hyperoxia

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Amir Hadanny, MD

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2018

First Posted

November 27, 2018

Study Start

January 1, 2016

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

November 27, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)