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Trial record 35 of 692 for:    CARBON DIOXIDE AND arterial

The Effects of MAP and EtCO2 on Venous Sinus Pressures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 6, 2019
First Posted Date  ICMJE March 8, 2019
Last Update Posted Date October 30, 2019
Actual Study Start Date  ICMJE June 20, 2019
Actual Primary Completion Date September 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2019)
  • Venous Sinus Pressures [ Time Frame: Baseline ]
  • Venous Sinus Pressures [ Time Frame: After intervention, up to 5 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03867461 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2019)
  • Venous Sinus Diameter [ Time Frame: Baseline ]
  • Venous Sinus Diameter [ Time Frame: After Intervention, up to 5 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of MAP and EtCO2 on Venous Sinus Pressures
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Idiopathic Intracranial Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • 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)
  • 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,

    Interventions:
    • Procedure: Venous Sinus Stenting
    • Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)
    • Other: Adjustment to Mean Arterial Pressure (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,

    Interventions:
    • 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)
  • 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,

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2019)
8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 25, 2019
Actual Primary Completion Date September 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults determined to be candidates for venous sinus stenting
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03867461
Other Study ID Numbers  ICMJE IRB00055942
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyle Fargen, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP