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The Effects of MAP and EtCO2 on Venous Sinus Pressures

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Completed

Conditions

Idiopathic Intracranial Hypertension

Treatments

Other: Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)
Procedure: Venous Sinus Stenting
Other: Adjustment to Mean Arterial Pressure (60-80 mmHg range)
Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)
Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range)

Study type

Interventional

Funder types

Other

Identifiers

NCT03867461
IRB00055942

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Adults determined to be candidates for venous sinus stenting

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

8 participants in 4 patient groups

Group A
Active Comparator group
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.
Treatment:
Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range)
Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)
Procedure: Venous Sinus Stenting
Group B
Active Comparator group
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,
Treatment:
Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)
Procedure: Venous Sinus Stenting
Other: Adjustment to Mean Arterial Pressure (60-80 mmHg range)
Group C
Active Comparator group
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,
Treatment:
Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range)
Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)
Procedure: Venous Sinus Stenting
Group D
Active Comparator group
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,
Treatment:
Other: Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)
Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range)
Procedure: Venous Sinus Stenting

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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