NCT03867461

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

June 20, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2019

Completed
Last Updated

May 12, 2020

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

March 6, 2019

Last Update Submit

May 8, 2020

Conditions

Idiopathic Intracranial Hypertension

Keywords

End-Tidal Carbon DioxideVenous Sinus StentingVenous Sinus Caliber and Pressures

Outcome Measures

Primary Outcomes (2)

  • Venous Sinus Pressures

    Baseline

  • Venous Sinus Pressures

    After intervention, up to 5 minutes

Secondary Outcomes (2)

  • Venous Sinus Diameter

    Baseline

  • Venous Sinus Diameter

    After Intervention, up to 5 minutes

Study Arms (4)

Group A

ACTIVE COMPARATOR

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.

Procedure: Venous Sinus StentingOther: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range)

Group B

ACTIVE COMPARATOR

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,

Procedure: Venous Sinus StentingOther: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)Other: Adjustment to Mean Arterial Pressure (60-80 mmHg range)

Group C

ACTIVE COMPARATOR

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,

Procedure: Venous Sinus StentingOther: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range)

Group D

ACTIVE COMPARATOR

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,

Procedure: Venous Sinus StentingOther: Adjustment to Mean Arterial Pressure (100-110 mmHg range)Other: Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)

Interventions

Venous Sinus StentingPROCEDURE

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).

Group AGroup BGroup CGroup D
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

Group AGroup BGroup C
Adjustment to Mean Arterial Pressure (100-110 mmHg range)OTHER

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

Group AGroup CGroup D
Adjustment to Mean Arterial Pressure (60-80 mmHg range)OTHER

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

Group B
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

Group D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults determined to be candidates for venous sinus stenting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (8)

  • Satti SR, Leishangthem L, Chaudry MI. Meta-Analysis of CSF Diversion Procedures and Dural Venous Sinus Stenting in the Setting of Medically Refractory Idiopathic Intracranial Hypertension. AJNR Am J Neuroradiol. 2015 Oct;36(10):1899-904. doi: 10.3174/ajnr.A4377. Epub 2015 Aug 6.

    PMID: 26251432BACKGROUND

  • Teleb MS, Cziep ME, Lazzaro MA, Gheith A, Asif K, Remler B, Zaidat OO. Idiopathic Intracranial Hypertension. A Systematic Analysis of Transverse Sinus Stenting. Interv Neurol. 2013;2(3):132-143. doi: 10.1159/000357503.

    PMID: 24999351BACKGROUND

  • Levitt MR, Albuquerque FC, Gross BA, Moon K, Jadhav AP, Ducruet AF, Crowley RW. Venous sinus stenting in patients without idiopathic intracranial hypertension. J Neurointerv Surg. 2017 May;9(5):512-515. doi: 10.1136/neurintsurg-2016-012405. Epub 2016 May 19.

    PMID: 27199383BACKGROUND

  • Ahmed RM, Wilkinson M, Parker GD, Thurtell MJ, Macdonald J, McCluskey PJ, Allan R, Dunne V, Hanlon M, Owler BK, Halmagyi GM. Transverse sinus stenting for idiopathic intracranial hypertension: a review of 52 patients and of model predictions. AJNR Am J Neuroradiol. 2011 Sep;32(8):1408-14. doi: 10.3174/ajnr.A2575. Epub 2011 Jul 28.

    PMID: 21799038BACKGROUND

  • West JL, Garner RM, Greeneway GP, Traunero JR, Aschenbrenner CA, Singh J, Wolfe SQ, Fargen KM. Venous waveform morphological changes associated with treatment of symptomatic venous sinus stenosis. J Neurointerv Surg. 2018 Nov;10(11):1108-1113. doi: 10.1136/neurintsurg-2018-013858. Epub 2018 Mar 21.

    PMID: 29563210BACKGROUND

  • Fargen KM, Spiotta AM, Hyer M, Lena J, Turner RD, Turk AS, Chaudry I. Comparison of venous sinus manometry gradients obtained while awake and under general anesthesia before venous sinus stenting. J Neurointerv Surg. 2017 Oct;9(10):990-993. doi: 10.1136/neurintsurg-2016-012608. Epub 2016 Sep 15.

    PMID: 27634954BACKGROUND

  • Raper DMS, Buell TJ, Chen CJ, Ding D, Starke RM, Liu KC. Intracranial venous pressures under conscious sedation and general anesthesia. J Neurointerv Surg. 2017 Oct;9(10):986-989. doi: 10.1136/neurintsurg-2017-012984. Epub 2017 Mar 30.

    PMID: 28360352BACKGROUND

  • West JL, Garner RM, Traunero JR, Wolfe SQ, Fargen KM. Changes in End-Tidal Carbon Dioxide Partial Pressure Alter Venous Sinus Pressure Measurements in Idiopathic Intracranial Hypertension. World Neurosurg. 2018 Dec;120:495-499. doi: 10.1016/j.wneu.2018.09.117. Epub 2018 Sep 26.

    PMID: 30266712BACKGROUND

MeSH Terms

Conditions

Pseudotumor Cerebri

Condition Hierarchy (Ancestors)

Intracranial HypertensionBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Kyle Fargen, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 8, 2019

Study Start

June 20, 2019

Primary Completion

September 25, 2019

Study Completion

September 25, 2019

Last Updated

May 12, 2020

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)