Therapeutic Hypercapnia After Aneurysmal Subarachnoid Hemorrhage - Optimum Duration of Hypercapnia
Primary Purpose
Vasospasm Intracranial
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Temporary hypercapnia
Sponsored by
About this trial
This is an interventional treatment trial for Vasospasm Intracranial focused on measuring SAH, Hypercapnia, DCI
Eligibility Criteria
Inclusion Criteria:
- Aneurysmal SAH
- Aneurysm occluded by clipping/coiling within 96 hours
- Hunt/Hess 3-5
- Fisher 2-4 on initial CT scan
- Intubated, sedated and mechanically ventilated patient
- Continous drainage of cerebrospinal fluid (CSF)
Exclusion Criteria:
- Age under 18 years
- Pregnancy
- Common obstructive lung disease (COLD)
- potential of hydrogen (pH) in ABG < 7,25
- ICP > 20 mmHg
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Optimum duration of hypercapnia
Arm Description
Daily serial measurement of 2 hours under target hypercapnia of pCO2 50 - 55 mmHg by changes of respirator settings once per day
Outcomes
Primary Outcome Measures
Cerebral blood flow (CBF)
Changes of CBF (absolute, ml/100g tissue/min) under changes of arterial pCO2
Secondary Outcome Measures
Cerebral tissue oxygen saturation
Changes of tissue oxygen saturation measured by near-infrared spectroscopy (NIRS)
Glasgow Outcome Score (GOS)
Glasgow Outcome Score (GOS 1 - 5, GOS 1 = Death, GOS 5 = none or low disability) after 14 days, after discharge and 6 months
Full Information
NCT ID
NCT04687605
First Posted
December 22, 2020
Last Updated
December 28, 2020
Sponsor
University of Wuerzburg
1. Study Identification
Unique Protocol Identification Number
NCT04687605
Brief Title
Therapeutic Hypercapnia After Aneurysmal Subarachnoid Hemorrhage - Optimum Duration of Hypercapnia
Official Title
Therapeutic Hypercapnia After Aneurysmal Subarachnoid Hemorrhage - Study for the Optimum Duration of Hypercapnia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wuerzburg
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Temporary hypercapnia leads to a reproducible increase of cerebral blood flow (CBF) and brain tissue oxygenation (StiO2) as shown in a previous study (Trial-Identification: NCT01799525). The aim of this study now was to measure the course of carbon dioxide partial pressure (pCO2) reactivity after prolonged hypercapnia, and to evaluate the therapeutic effect of graded hypercapnia.
Detailed Description
Cerebral vasospasm still is the leading cause of delayed cerebral ischemia (DCI) and secondary ischemic deficits after aneurysmal subarachnoid hemorrhage (SAH). Hypercapnia leads to a reproducible increase of cerebral blood flow (CBF) and brain tissue oxygenation (StiO2) as shown in a previous study (Trial-Identification: NCT01799525). Furthermore, the increase of CBF and StiO2 sustained after normalization of ventilation and no rebound effect was found. So, a possible optimization of the hypercapnic period may lead to prolonged effects of increased CBF and StiO2. Aim of this stuy is to find the ideal duration of hypercapnia and to evaluate the therapeutic effect of graded hypercapnia. For this, intubated and mechanically ventilated patients with an aneurysmal SAH Hunt/Hess 3-5, Fisher grade 2-4 on the initial CT scan and supplied with an external ventricular drainage will be included within the first 96 hours after ictus. Between day 4 and 14 they undergo a trial intervention in which the respiratory minute volume will be reduced in order to maintain a target PaCO2 of 50 - 55 mmHg for 2 hours. Arterial blood gas analysis (ABG) and transcranial Doppler sonography (TCD) is performed in 15-minute intervals. Intracranial pressure (ICP), cerebral perfusion pressure (CPP), and cardiovascular parameters are monitored continuously, serial measurement of CBF and StiO2 under continous hypercapnia is performed. Primary endpoint of this trial is change of CBF under hypercapnia, secondary endpoints are StiO2, measures non-invasively with near-infrared spectroscopy, mean flow velocity of intracranial vessels in TCD, delayed cerebral infarction in cranial CT and Glasgow Outcome Score (GOS) after 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasospasm Intracranial
Keywords
SAH, Hypercapnia, DCI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Optimum duration of hypercapnia
Arm Type
Experimental
Arm Description
Daily serial measurement of 2 hours under target hypercapnia of pCO2 50 - 55 mmHg by changes of respirator settings once per day
Intervention Type
Procedure
Intervention Name(s)
Temporary hypercapnia
Intervention Description
Temporary daily hypercapnia for 2 hours between day 4 and 14 after SAH
Primary Outcome Measure Information:
Title
Cerebral blood flow (CBF)
Description
Changes of CBF (absolute, ml/100g tissue/min) under changes of arterial pCO2
Time Frame
2-4 hours, day 4-14 after SAH
Secondary Outcome Measure Information:
Title
Cerebral tissue oxygen saturation
Description
Changes of tissue oxygen saturation measured by near-infrared spectroscopy (NIRS)
Time Frame
2-4 hours, day 4-14 after SAH
Title
Glasgow Outcome Score (GOS)
Description
Glasgow Outcome Score (GOS 1 - 5, GOS 1 = Death, GOS 5 = none or low disability) after 14 days, after discharge and 6 months
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aneurysmal SAH
Aneurysm occluded by clipping/coiling within 96 hours
Hunt/Hess 3-5
Fisher 2-4 on initial CT scan
Intubated, sedated and mechanically ventilated patient
Continous drainage of cerebrospinal fluid (CSF)
Exclusion Criteria:
Age under 18 years
Pregnancy
Common obstructive lung disease (COLD)
potential of hydrogen (pH) in ABG < 7,25
ICP > 20 mmHg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Therapeutic Hypercapnia After Aneurysmal Subarachnoid Hemorrhage - Optimum Duration of Hypercapnia
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