The Effects of MAP and EtCO2 on Venous Sinus Pressures

Not Applicable

Completed

• Conditions: Idiopathic Intracranial Hypertension
• Interventions: Procedure: Venous Sinus Stenting; Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range); Other: Adjustment to Mean Arterial Pressure (60-80 mmHg range); Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range); Other: Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)

• Registration Number: NCT03867461
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-07
• Study First Posted: 2019-03-08
• Status Verified: 2019-04
• Study Start: 2019-06-20
• Primary Completion: 2019-09-25
• Study Completion: 2019-09-25
• Last Update Submitted: 2020-05-08
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Adults determined to be candidates for venous sinus stenting

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)	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.
Group B	Venous Sinus Stenting	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,
Group A	Venous Sinus Stenting	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.
Group C	Venous Sinus Stenting	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,
Group B	Adjustment to Mean Arterial Pressure (60-80 mmHg range)	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,
Group D	Venous Sinus Stenting	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,
Group A	Adjustment to Mean Arterial Pressure (100-110 mmHg range)	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.
Group C	Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)	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,
Group C	Adjustment to Mean Arterial Pressure (100-110 mmHg range)	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,
Group D	Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)	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,
Group B	Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)	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,
Group D	Adjustment to Mean Arterial Pressure (100-110 mmHg range)	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,

Primary Outcome Measures

Name	Time	Method
Venous Sinus Pressures	After intervention, up to 5 minutes

Secondary Outcome Measures

Name	Time	Method
Venous Sinus Diameter	After Intervention, up to 5 minutes

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States