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Permanent Cerebral Oxymetry Monitoring for Early Diagnosis and Treatment of Delayed Vasospasm After Subarachnoid Hemorrhage (COMOVA)

Primary Purpose

Subarachnoid Hemorrhage

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cerebral oxymetry monitoring (NIRS)
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Subarachnoid Hemorrhage focused on measuring Intracranial oxymetry, Subarachnoid Hemorrhage, Vasospasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women
  • Age ≥ 18 years
  • HSA of aneurysmal etiology less than 4 days before inclusion diagnosed by clinical presentation and emergency imaging
  • HSA "severe" defined according to the WFNS ≥ III
  • Intubated-ventilated patient or any other reason preventing a contributing neurological examination
  • Affiliate or beneficiary of a social security scheme
  • Free, informed and written consent signed by the representative

Exclusion Criteria:

  • Age <18 years
  • Significant vasospasm as soon as the detection was detected on the initial imaging
  • Possible Neurological Surveillance
  • Intra-parenchymal frontal haematoma limiting the quality of measurement, diagnosed on imaging (Less than 25mm deep from the skin)
  • Patient in limitation of active therapeutics or with high probability of soon limitation of active therapeutics
  • Adhesive allergy to measuring patches
  • Patient under guardianship or safeguard of justice
  • Refusal of legal representative

Sites / Locations

  • CHU de BordeauxRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cerebral oxymetry monitoring (NIRS)

Arm Description

Cerebral oxymetry (NIRS) -by rSO2 measurement - in order to detect vasospasm in patient with severe subarachnoid hemorrhage compare to standard monitoring tools

Outcomes

Primary Outcome Measures

Permanent measurement of cerabral oxymetry (rSO2) by NIRS system
Difference between NIRS basal measurement entre la mesure basale du NIRS (NIRS average on the first hour of recording respectively on the left and right) and the NIRS measurement during the follow-up (lowest mean NIRS observed over one hour in patients without vasospasm diagnosed by the reference test or mean NIRS observed over the hour.

Secondary Outcome Measures

Severity of angiographic spasm
Not significant (<50%) Significant (>50%) Severe.
Pti02 value
Pti02 value (mm Hg)
Pti02 value
Pti02 value (mm Hg)
Pti02 value
Pti02 value (mm Hg)

Full Information

First Posted
July 31, 2019
Last Updated
March 30, 2022
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT04042571
Brief Title
Permanent Cerebral Oxymetry Monitoring for Early Diagnosis and Treatment of Delayed Vasospasm After Subarachnoid Hemorrhage
Acronym
COMOVA
Official Title
Permanent Cerebral Oxymetry Monitoring for Early Diagnosis and Treatment of Delayed Vasospasm After Subarachnoid Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Transcranial Doppler ultrasound (TCD) monitoring and CT-scanner perfusion are useful but imperfect tools to identify vasospasm and allow intervention to avoid infarction. Permanent monitoring of cerebral tissue oximetry (rSO2) by NIRS, a noninvasive method could allow better vasospasm detection. This study will evaluate diagnostic accuracy of cerebral oxymetry (NIRS) -by rSO2 measurement - in order to detect vasospasm in patient with severe subarachnoid hemorrhage compare to standard monitoring tools.
Detailed Description
Delayed vasospasm is a serious complication of aneurismal subarachnoid haemorhage (SAH) significantly influencing morbidity and mortality. Mostly observed between days 4 and 10 after aneurismal rupture, its incidence is higher in cases of severe SAH. Vasospasm strongly affects prognisis generating delayed cerebral ischemia. Clinical deterioration (focal neurological deficit) is the best way to detect severe vasospasm. Unfortunately, most of severe SAH are intubated and sedated prohibiting neurological evaluation. In these frequent situations, Transcranial Doppler (TCD), clinical and biological monitoring, CT-scanner (angio-CT and Perfusion-CT), MRI and cerebral angiography are routinely used to detect vasospasm. Yet, these tools have imperfect sensitivity and specificty delaying diagnosis and treatment. Near-InfraRed Spectroscopy (NIRS) is a non-invasive method measuring tissue oxygenation by regional saturation of capillary-oxygenated hemoglobin (rSO2). This technology demonstrated ability to measure cerebral oxygenation and has previously been reported to monitor carotid and pediatric surgery. To date a few studies also reported NIRS monitoring feasability in post-SAH vasospasm. Our aim is here to evaluate NIRS monitoring for the diagnosis of vasospasm in severe SAH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage
Keywords
Intracranial oxymetry, Subarachnoid Hemorrhage, Vasospasm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cerebral oxymetry monitoring (NIRS)
Arm Type
Experimental
Arm Description
Cerebral oxymetry (NIRS) -by rSO2 measurement - in order to detect vasospasm in patient with severe subarachnoid hemorrhage compare to standard monitoring tools
Intervention Type
Device
Intervention Name(s)
Cerebral oxymetry monitoring (NIRS)
Intervention Description
Near-InfraRed Spectroscopy (NIRS) is a non-invasive method measuring tissue oxygenation by regional saturation of capillary-oxygenated hemoglobin (rSO2). Starting on day 4 after aneurismal rupture NIRS electrods will be placed and maintained until day 12 permanently and blindly recording rSO2. Patients will be monitored following daily practice recommandations inclunding vasospasm detection and treatment.
Primary Outcome Measure Information:
Title
Permanent measurement of cerabral oxymetry (rSO2) by NIRS system
Description
Difference between NIRS basal measurement entre la mesure basale du NIRS (NIRS average on the first hour of recording respectively on the left and right) and the NIRS measurement during the follow-up (lowest mean NIRS observed over one hour in patients without vasospasm diagnosed by the reference test or mean NIRS observed over the hour.
Time Frame
From day 4 to day 12 post aneurysmal subarachnoid hemorrhage
Secondary Outcome Measure Information:
Title
Severity of angiographic spasm
Description
Not significant (<50%) Significant (>50%) Severe.
Time Frame
Day 8 post aneurysmal subarachnoid hemorrhage
Title
Pti02 value
Description
Pti02 value (mm Hg)
Time Frame
Day 4 post aneurysmal subarachnoid hemorrhage
Title
Pti02 value
Description
Pti02 value (mm Hg)
Time Frame
Day 8 post aneurysmal subarachnoid hemorrhage
Title
Pti02 value
Description
Pti02 value (mm Hg)
Time Frame
Day 12 post aneurysmal subarachnoid hemorrhage

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women Age ≥ 18 years HSA of aneurysmal etiology less than 4 days before inclusion diagnosed by clinical presentation and emergency imaging HSA "severe" defined according to the WFNS ≥ III Intubated-ventilated patient or any other reason preventing a contributing neurological examination Affiliate or beneficiary of a social security scheme Free, informed and written consent signed by the representative Exclusion Criteria: Age <18 years Significant vasospasm as soon as the detection was detected on the initial imaging Possible Neurological Surveillance Intra-parenchymal frontal haematoma limiting the quality of measurement, diagnosed on imaging (Less than 25mm deep from the skin) Patient in limitation of active therapeutics or with high probability of soon limitation of active therapeutics Adhesive allergy to measuring patches Patient under guardianship or safeguard of justice Refusal of legal representative
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaultier Marnat
Phone
05 56 79 48 80
Ext
+33
Email
gaultier.marnat@chu-bordeaux.fr
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33 076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Galtier Marnat
Phone
05 56 79 48 80
Ext
+33
Email
gaultier.marnat@chu-bordeaux.fr

12. IPD Sharing Statement

Learn more about this trial

Permanent Cerebral Oxymetry Monitoring for Early Diagnosis and Treatment of Delayed Vasospasm After Subarachnoid Hemorrhage

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