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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03867461
Other study ID # IRB00055942
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 20, 2019
Est. completion date September 25, 2019

Study information

Verified date April 2019
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date September 25, 2019
Est. primary completion date September 25, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults determined to be candidates for venous sinus stenting

Study Design


Related Conditions & MeSH terms


Intervention

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
Adjustment to Mean Arterial Pressure (100-110 mmHg range)
Mean arterial pressure will be adjusted to fall in the 100-110 mmHg range
Adjustment to Mean Arterial Pressure (60-80 mmHg range)
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)
End-tidal carbon dioxide concentrations will be adjusted to fall in the 24-26 mmHg range

Locations

Country Name City State
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Venous Sinus Pressures Baseline
Primary Venous Sinus Pressures After intervention, up to 5 minutes
Secondary Venous Sinus Diameter Baseline
Secondary Venous Sinus Diameter After Intervention, up to 5 minutes
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