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Completed

NCT Number: NCT03867461

The Effects of MAP and EtCO2 on Venous Sinus Pressures

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.

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Key information

Conditions

Idiopathic Intracranial Hypertension Brain Diseases Central Nervous System Diseases Intracranial Hypertension Nervous System Diseases Pseudotumor Cerebri

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults determined to be candidates for venous sinus stenting

Treatment and study plan

venous sinus stenting

Procedure

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).

Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)

Other

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

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

Other

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

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

Other

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

Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)

Other

End-tidal carbon dioxide concentrations will be adjusted to fall in the 24-26 mmHg range

Primary outcomes

  1. Venous Sinus Pressures

    Time frame: Baseline

  2. Venous Sinus Pressures

    Time frame: After intervention, up to 5 minutes

Secondary outcomes

  1. Venous Sinus Diameter

    Time frame: Baseline

  2. Venous Sinus Diameter

    Time frame: After Intervention, up to 5 minutes

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 8, 2019
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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