Interest of Tissue Oxygen Pressure (PtiO2) Monitoring to Detect a Vasospasm Post Aneurysmal Subarachnoid Hemorrhage (O2-VASO)

November 29, 2017 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients, hospitalized in intensive care unit and sedated, with severe aneurysmal subarachnoid hemorrhage

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tissue Oxygen Pressure
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 15, 2015

Primary Completion (ACTUAL)

September 15, 2016

Study Completion (ACTUAL)

September 15, 2016

Study Registration Dates

First Submitted

November 29, 2017

First Submitted That Met QC Criteria

November 29, 2017

First Posted (ACTUAL)

December 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2017

Last Update Submitted That Met QC Criteria

November 29, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE_20151215_1_SWG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Subarachnoid Hemorrhage, Aneurysmal

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe