Hypercapnia to Prevent Secondary Ischemia in SAH (SAHCO2)
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|ClinicalTrials.gov Identifier: NCT01799525|
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : December 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Aneurysmal Subarachnoid Hemorrhage||Procedure: Hypercapnia by reduction of respiratory volume||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Therapeutical Hypercapnia to Prevent Secondary Ischemic Events in Aneurysmal Subarachnoid Hemorrhage (aSAH)|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||August 2014|
Intervention: SAH patients are subjected to gradual hypercapnia by reduction of respiratory volume in one trial session every day. PaCO2 is raised from normocapnia to 50 mmHg for 10 - 15 minutes and 60 mmHg for 10 - 15 minutes.
Procedure: Hypercapnia by reduction of respiratory volume
By reduction of the respiratory volume, PaCO2 is raised while paO2 is kept constant by modulation of the oxygen supply through the respirator,
- Cerebral Blood Flow [ Time Frame: For an average of two weeks after aSAH ]Between day 4 and 14, PaCO2 is gradually raised from normocapnic values (40 mmHg) to hypercapnic values (50 and 60 mmHg). CBF is continuously measured during this intervention. Patients are clinically and radiologically followed for 6 months.
- Cerebral oxygen saturation [ Time Frame: For an average of two weeks after aSAH ]Oxygen saturation by NIRS is measured continuously for 2 weeks after aSAH.
- intracranial pressure (ICP) [ Time Frame: For an average of two weeks ]ICP is continuously measured by an external ventricular drainage throughout the intervention period.
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): NCT01799525
|Department of Neurosurgery, University of Wuerzburg|
|Wuerzburg, Bavaria, Germany, 97080|
|Principal Investigator:||Thomas Westermaier, MD||Department of Neurosurgery, University of Wuerzburg, Germany|
|Study Director:||Ekkehard Kunze, MD||Department of Neurosurgery, University of Wuerzburg|