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Trial record 35 of 668 for:    CARBON DIOXIDE AND arterial

The Effects of MAP and EtCO2 on Venous Sinus Pressures

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ClinicalTrials.gov Identifier: NCT03867461
Recruitment Status : Completed
First Posted : March 8, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Idiopathic Intracranial Hypertension Procedure: Venous Sinus Stenting Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range) Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range) Other: Adjustment to Mean Arterial Pressure (60-80 mmHg range) Other: Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : June 20, 2019
Actual Primary Completion Date : September 25, 2019
Actual Study Completion Date : September 25, 2019


Arm Intervention/treatment
Active Comparator: Group A

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 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

Active Comparator: Group B

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

Active Comparator: Group C

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 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

Active Comparator: Group D

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 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 Mean Arterial Pressure (100-110 mmHg range)
Mean arterial pressure will be adjusted to fall in the 100-110 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




Primary Outcome Measures :
  1. Venous Sinus Pressures [ Time Frame: Baseline ]
  2. Venous Sinus Pressures [ Time Frame: After intervention, up to 5 minutes ]

Secondary Outcome Measures :
  1. Venous Sinus Diameter [ Time Frame: Baseline ]
  2. Venous Sinus Diameter [ Time Frame: After Intervention, up to 5 minutes ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults determined to be candidates for venous sinus stenting

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867461


Locations
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Kyle Fargen, MD Wake Forest University Health Sciences

Publications:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03867461     History of Changes
Other Study ID Numbers: IRB00055942
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
End-Tidal Carbon Dioxide
Venous Sinus Stenting
Venous Sinus Caliber and Pressures
Additional relevant MeSH terms:
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Intracranial Hypertension
Pseudotumor Cerebri
Hypertension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases