Back to resultsThe Effects of MAP and EtCO2 on Venous Sinus Pressures
Primary Purpose
Idiopathic Intracranial Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Venous Sinus Stenting
Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)
Adjustment to Mean Arterial Pressure (100-110 mmHg range)
Adjustment to Mean Arterial Pressure (60-80 mmHg range)
Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)
Sponsored by
About this trial
This is an interventional basic science trial for Idiopathic Intracranial Hypertension focused on measuring End-Tidal Carbon Dioxide, Venous Sinus Stenting, Venous Sinus Caliber and Pressures
Eligibility Criteria
Inclusion Criteria:
- Adults determined to be candidates for venous sinus stenting
Sites / Locations
- Wake Forest University Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Group D
Arm Description
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.
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,
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,
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,
Outcomes
Primary Outcome Measures
Venous Sinus Pressures
Venous Sinus Pressures
Secondary Outcome Measures
Venous Sinus Diameter
Venous Sinus Diameter
Full Information
NCT ID
NCT03867461
First Posted
March 6, 2019
Last Updated
May 8, 2020
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03867461
Brief Title
The Effects of MAP and EtCO2 on Venous Sinus Pressures
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
September 25, 2019 (Actual)
Study Completion Date
September 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Intracranial Hypertension
Keywords
End-Tidal Carbon Dioxide, Venous Sinus Stenting, Venous Sinus Caliber and Pressures
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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,
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
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,
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
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,
Intervention Type
Procedure
Intervention Name(s)
Venous Sinus Stenting
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Adjustment to Mean Arterial Pressure (100-110 mmHg range)
Intervention Description
Mean arterial pressure will be adjusted to fall in the 100-110 mmHg range
Intervention Type
Other
Intervention Name(s)
Adjustment to Mean Arterial Pressure (60-80 mmHg range)
Intervention Description
Mean arterial pressure will be adjusted to fall in the 60-80 mmHg range
Intervention Type
Other
Intervention Name(s)
Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)
Intervention Description
End-tidal carbon dioxide concentrations will be adjusted to fall in the 24-26 mmHg range
Primary Outcome Measure Information:
Title
Venous Sinus Pressures
Time Frame
Baseline
Title
Venous Sinus Pressures
Time Frame
After intervention, up to 5 minutes
Secondary Outcome Measure Information:
Title
Venous Sinus Diameter
Time Frame
Baseline
Title
Venous Sinus Diameter
Time Frame
After Intervention, up to 5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults determined to be candidates for venous sinus stenting
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Fargen, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26251432
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.
Results Reference
background
PubMed Identifier
24999351
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. doi: 10.1159/000357503.
Results Reference
background
PubMed Identifier
27199383
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.
Results Reference
background
PubMed Identifier
21799038
Citation
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.
Results Reference
background
PubMed Identifier
29563210
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.
Results Reference
background
PubMed Identifier
27634954
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.
Results Reference
background
PubMed Identifier
28360352
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.
Results Reference
background
PubMed Identifier
30266712
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.
Results Reference
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The Effects of MAP and EtCO2 on Venous Sinus Pressures
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