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NCT03361722 Clinical Trial

Interest of Tissue Oxygen Pressure (PtiO2) Monitoring to Detect a Vasospasm Post Aneurysmal Subarachnoid Hemorrhage

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

— O2-VASO  

Official title:
Interest of Tissue Oxygen Pressure (PtiO2) Monitoring to Detect a Vasospasm Post Aneurysmal Subarachnoid Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03361722
Other study ID # CE_20151215_1_SWG
Secondary ID
Status Completed
Phase N/A
First received November 29, 2017
Last updated November 29, 2017
Start date February 15, 2015
Est. completion date September 15, 2016

Study information
Verified date November 2017
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Vasospasm is a current complication after aneurysmal subarachnoid hemorrhage and often and often associated with brain ischemia. This complication is difficult to detect, because clinical examination is hardly helpful in sedated patients and the performances of transcranial doppler can only detect the spasm of middle cerebral arteries.

Tissue Oxygen Pressure (PtiO2) Monitoring allows early detection of brain oxygenation local modifications and of brain ischemia, via continuous monitoring.

This study aims to assess the performance of the tissue oxygen pressure monitoring in detecting a vasospasm post aneurysmal subarachnoid hemorrhage.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date September 15, 2016
Est. primary completion date September 15, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- severe aneurysmal subarachnoid hemorrhage

- patient sedated

- patient hospitalized in intensive care unit between January 2013 and August 2015

- multimodal neurologic monitoring including Tissue Oxygen Pressure and transcranial doppler

Exclusion Criteria:

- insonation impossible

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Outcome
Type Measure Description Time frame Safety issue
Primary Tissue Oxygen Pressure baseline
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