The Effects of MAP and EtCO2 on Venous Sinus Pressures

Study Overview
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Brief Summary
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The purpose of this study is to further elaborate the role of both arterial blood pressure and end-tidal carbon dioxide concentration on measured venous pressures.

Detailed Description
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To prospectively evaluate the effect of changes in end-tidal carbon dioxide and arterial blood pressure on venous sinus pressure measurements in patients undergoing venous sinus stenting under general anesthesia. Venous sinus pressure measurements will increase with increases in both arterial blood pressure and end-tidal carbon dioxide concentrations.

Official Title
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Prospective Measurement of Blood Pressure and End Tidal Carbon Dioxide Content Effects on Venous Sinus Caliber and Pressures in Patients With Idiopathic Intracranial Hypertension Undergoing Stenting

Conditions
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Idiopathic Intracranial Hypertension

Intervention / Treatment
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* Procedure: Venous Sinus Stenting
* Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)
* Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range)
* Other: Adjustment to Mean Arterial Pressure (60-80 mmHg range)
* Other: Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults determined to be candidates for venous sinus stenting

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Adult patients determined to be candidates for venous sinus stenting. End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention: For Group A: Initial Recording: Mean Arterial Pressure 60-80 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 100-80 mmHg, End tidal CO2 38-40 mmHg. | Procedure: Venous Sinus Stenting<br>* Venous sinus stenting is performed under general anesthesia. Patients are loaded with aspirin and clopidogrel before the procedure. After induction, the right femoral vein is accessed and an 8 F sheath is placed. Intravenous heparin is administered. A 0.070-0.088 guide catheter is navigated into the ipsilateral jugular vein near the jugular bulb. Pre-stenting manometry is performed in every patient. To do so, a Renegade Hi-Flo microcatheter is navigated into the superior sagittal sinus and then used to measure ipsilateral venous pressures across the site of outflow obstruction (this will be the time point where the study intervention will be performed).<br>Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)<br>* End-tidal carbon dioxide concentrations will be adjusted to fall in the End-tidal carbon dioxide concentrations will be adjusted to fall in the 38-40 mmHg range<br>Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range)<br>* Mean arterial pressure will be adjusted to fall in the 100-110 mmHg range<br>|
| Active Comparator: Group B<br>Adult patients determined to be candidates for venous sinus stenting. End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention: For Group B: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 60-80 mmHg, End tidal CO2 38-40 mmHg, | Procedure: Venous Sinus Stenting<br>* Venous sinus stenting is performed under general anesthesia. Patients are loaded with aspirin and clopidogrel before the procedure. After induction, the right femoral vein is accessed and an 8 F sheath is placed. Intravenous heparin is administered. A 0.070-0.088 guide catheter is navigated into the ipsilateral jugular vein near the jugular bulb. Pre-stenting manometry is performed in every patient. To do so, a Renegade Hi-Flo microcatheter is navigated into the superior sagittal sinus and then used to measure ipsilateral venous pressures across the site of outflow obstruction (this will be the time point where the study intervention will be performed).<br>Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)<br>* End-tidal carbon dioxide concentrations will be adjusted to fall in the End-tidal carbon dioxide concentrations will be adjusted to fall in the 38-40 mmHg range<br>Other: Adjustment to Mean Arterial Pressure (60-80 mmHg range)<br>* Mean arterial pressure will be adjusted to fall in the 60-80 mmHg range<br>|
| Active Comparator: Group C<br>Adult patients determined to be candidates for venous sinus stenting. End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention: For Group C: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 24-26 mmHg, Subsequent Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg, | Procedure: Venous Sinus Stenting<br>* Venous sinus stenting is performed under general anesthesia. Patients are loaded with aspirin and clopidogrel before the procedure. After induction, the right femoral vein is accessed and an 8 F sheath is placed. Intravenous heparin is administered. A 0.070-0.088 guide catheter is navigated into the ipsilateral jugular vein near the jugular bulb. Pre-stenting manometry is performed in every patient. To do so, a Renegade Hi-Flo microcatheter is navigated into the superior sagittal sinus and then used to measure ipsilateral venous pressures across the site of outflow obstruction (this will be the time point where the study intervention will be performed).<br>Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)<br>* End-tidal carbon dioxide concentrations will be adjusted to fall in the End-tidal carbon dioxide concentrations will be adjusted to fall in the 38-40 mmHg range<br>Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range)<br>* Mean arterial pressure will be adjusted to fall in the 100-110 mmHg range<br>|
| Active Comparator: Group D<br>Adult patients determined to be candidates for venous sinus stenting. End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention: For Group D: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 100-100 mmHg, End tidal CO2 24-24 mmHg, | Procedure: Venous Sinus Stenting<br>* Venous sinus stenting is performed under general anesthesia. Patients are loaded with aspirin and clopidogrel before the procedure. After induction, the right femoral vein is accessed and an 8 F sheath is placed. Intravenous heparin is administered. A 0.070-0.088 guide catheter is navigated into the ipsilateral jugular vein near the jugular bulb. Pre-stenting manometry is performed in every patient. To do so, a Renegade Hi-Flo microcatheter is navigated into the superior sagittal sinus and then used to measure ipsilateral venous pressures across the site of outflow obstruction (this will be the time point where the study intervention will be performed).<br>Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range)<br>* Mean arterial pressure will be adjusted to fall in the 100-110 mmHg range<br>Other: Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)<br>* End-tidal carbon dioxide concentrations will be adjusted to fall in the 24-26 mmHg range<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous Sinus Pressures |  | Baseline | 
| Venous Sinus Pressures |  | After intervention, up to 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous Sinus Diameter |  | Baseline | 
| Venous Sinus Diameter |  | After Intervention, up to 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End-Tidal Carbon Dioxide, Venous Sinus Stenting, Venous Sinus Caliber and Pressures