NCT02105194

Brief Summary

Chart review of patients who received hyperbaric oxygen therapy for cerebral decompression illness who also underwent SPECT brain blood flow imaging to see if SPECT brain imaging tracks and is consistent with the clinical condition of the patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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, 2007

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

10.9 years

First QC Date

March 30, 2014

Last Update Submit

April 16, 2017

Conditions

Cerebral Decompression Illness, All Phases

Keywords

cerebral decompression illness

Outcome Measures

Primary Outcomes (1)

  • SPECT brain imaging

    Comparison of SPECT brain imaging chart copy of radiological reading before or early in the treatment history to SPECT brain imaging chart copy of radiological reading after treatment. Imaging will be scored as better, worse, or no change based on resolution of defects or improvement in pattern of injury.

    Within one month after completion of hyperbaric oxygen therapy

Secondary Outcomes (2)

  • Symptoms of cerebral decompression illness

    Within one month after hyperbaric oxygen therapy

  • Abnormal physical exam findings

    Within one month after hyperbaric oxygen therapy

Study Arms (1)

Hyperbaric oxygen therapy

EXPERIMENTAL

Hyperbaric oxygen therapy

Drug: Hyperbaric oxygen therapy

Interventions

Hyperbaric oxygen therapyDRUG

total body exposure to greater than atmospheric pressure oxygen

Hyperbaric oxygen therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients in the P.I.'s practice who underwent hyperbaric oxygen therapy for cerebral decompression illness in the previous two decades who also underwent SPECT brain blood flow imaging early in the course of treatment and following completion of hyperbaric oxygen therapy.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Physicians Center

Marrero, Louisiana, 70072, United States

RECRUITING

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Paul G Harch, M.D.

    LSU School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul G Harch, M.D.

CONTACT

504-309-4948paulharchmd@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor of Medicine

Study Record Dates

First Submitted

March 30, 2014

First Posted

April 7, 2014

Study Start

January 1, 2007

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

April 18, 2017

Record last verified: 2017-04

Locations

US(1)