Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Cerebral Decompression Illness

Phase 1

• Conditions: Cerebral Decompression Illness, All Phases
• Interventions: Drug: Hyperbaric oxygen therapy

• Registration Number: NCT02105194
• Lead Sponsor: Paul G. Harch, M.D.

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.

Detailed Description

SPECT brain imaging has been shown to be the most sensitive imaging modality for cerebral decompression illness. This study is a retrospective review of the PI's experience using SPECT brain imaging in the diagnosis and treatment of all phases of cerebral decompression illness over the past two decades. The purpose of the study is to see if the functional imaging is consistent with the clinical condition and cognitive testing. Chart review of symptoms, and physical exam findings will be compared before and after treatment to SPECT brain imaging radiological readings to assess concordance.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2014-03-30
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-16
• Last Update Posted: 2017-04-18
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 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.

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyperbaric oxygen therapy	Hyperbaric oxygen therapy	Hyperbaric oxygen therapy

Primary Outcome Measures

Name	Time	Method
SPECT brain imaging	Within one month after completion of hyperbaric oxygen therapy	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.

Secondary Outcome Measures

Name	Time	Method
Symptoms of cerebral decompression illness	Within one month after hyperbaric oxygen therapy	Chart reports of patients' symptoms of cerebral decompression illness before hyperbaric oxygen therapy will be compared to symptoms after hyperbaric oxygen therapy and rated as better, worse, or no change.
Abnormal physical exam findings	Within one month after hyperbaric oxygen therapy	Chart reports of abnormal physical exam findings before hyperbaric oxygen therapy will be compared to chart reports of physical exam findings after hyperbaric oxygen therapy and rated as better, worse, or no change.

Trial Locations

Locations (1)

Family Physicians Center; 🇺🇸 Marrero, Louisiana, United States