NCT03867461

The Effects of MAP and EtCO2 on Venous Sinus Pressures

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Intracranial Hypertension

Interventions

Type	Name	Description
PROCEDURE	Venous Sinus Stenting	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).
OTHER	Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)	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
OTHER	Adjustment to Mean Arterial Pressure (100-110 mmHg range)	Mean arterial pressure will be adjusted to fall in the 100-110 mmHg range
OTHER	Adjustment to Mean Arterial Pressure (60-80 mmHg range)	Mean arterial pressure will be adjusted to fall in the 60-80 mmHg range
OTHER	Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)	End-tidal carbon dioxide concentrations will be adjusted to fall in the 24-26 mmHg range

Timeline

• Start date: 2019-06-20
• Primary completion: 2019-09-25
• Completion: 2019-09-25
• First posted: 2019-03-08
• Last updated: 2020-05-12

Locations

1 site across 1 country: United States