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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03867461
Enrollment
8
Registered
2019-03-08
Start date
2019-06-20
Completion date
2019-09-25
Last updated
2020-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Intracranial Hypertension

Keywords

End-Tidal Carbon Dioxide, Venous Sinus Stenting, Venous Sinus Caliber and Pressures

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.

Interventions

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).

OTHERAdjustment 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

OTHERAdjustment to Mean Arterial Pressure (100-110 mmHg range)

Mean arterial pressure will be adjusted to fall in the 100-110 mmHg range

OTHERAdjustment to Mean Arterial Pressure (60-80 mmHg range)

Mean arterial pressure will be adjusted to fall in the 60-80 mmHg range

OTHERAdjustment 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

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults determined to be candidates for venous sinus stenting

Design outcomes

Primary

MeasureTime frame
Venous Sinus PressuresBaseline

Secondary

MeasureTime frame
Venous Sinus DiameterBaseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026