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The Effects of MAP and EtCO2 on Venous Sinus Pressures

NCT03867461 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-05-12

No results posted yet for this study

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.

Conditions

  • Idiopathic Intracranial Hypertension

Interventions

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

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Kyle Fargen, MD · Wake Forest University Health Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2019-09-25
Completion
2019-09-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03867461 on ClinicalTrials.gov