Oxygenation of the Cerebrum and Cooling During TAVI - Part I
NCT ID: NCT01759563
Last Updated: 2013-01-03
Study Results
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Basic Information
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COMPLETED
PHASE3
6 participants
INTERVENTIONAL
2012-07-31
2012-12-31
Brief Summary
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Detailed Description
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6 patients selected for Transcutaneous Aortic Valve Implantation (TAVI)-procedure will be subjected to intra-operative transnasal cooling (RhinoChill) ; cooling will be started after induction of anesthesia until tympanic temperature achieves 34° (cooling will be continued until 33°C of tympanic temperature, below 33°C active cooling will be stopped)
No intra-aortic catheter will be inserted before tympanic temperature reaches 34°
The aim of this study is to test the safety (as referring to routinely used neuromonitoring : ForeSight cerebral tissue oxygen saturation (SctO2) monitoring; and as referring to cardiovascular stability : blood pressure \& heartrate) and feasibility (as referring to temperature characteristics) of brain cooling during TAVI (cerebral (or tympanic) cooling rate, differential tympanic-rectal cooling rate, rectal cooling rate, time needed to obtain tympanic temperature below 34°)
Patients will be monitored with FORE-SIGHT cerebral oximeter (regional cerebral oxygen saturation, sensors placed on patient's forehead) and BIS VISTA (bilateral continuousEEG).
Tympanic temperature will be measured every 5 minutes while oesophageal and blood temperature will be continuously measured.
* Neuromonitoring (Fore-Sight, Bispectral Index (BIS) Vista) will be started before induction of anesthesia and cooling
* Transnasal cooling will be started after induction of anesthesia until a target tympanic temperature of 34°C
* Core temperature will not be monitored by esophageal (caveat interaction TEE probe), but by rectal and blood temperature
* TAVI-procedure will be started at a tympanic temperature of 34°C
* Arterial CO2 tension (PaCO2) will be checked every 30 minutes intra-operatively (target=normocapnia) by arterial blood gas analysis to maintain strict normocapnia
* and the end of the TAVI-procedure, patient will be rewarmed at a max rate of 0.8°/h by total body bair hugger
* when patient reaches tympanic and systemic (rectal) temperature of 35.5°C, extubation can be performed
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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single arm study
nasopharyngeal targeted brain cooling
Interventions
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nasopharyngeal targeted brain cooling
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Hasselt University
OTHER
Responsible Party
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Prof Dr Cathy De Deyne
Prof Dr Jo Dens
Principal Investigators
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Cathy De Deyne, Md, PhD
Role: PRINCIPAL_INVESTIGATOR
Ziekenhuis Oost-Limburg
Locations
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Ziekenhuis Oost-Limburg
Genk, , Belgium
Countries
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References
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Castren M, Nordberg P, Svensson L, Taccone F, Vincent JL, Desruelles D, Eichwede F, Mols P, Schwab T, Vergnion M, Storm C, Pesenti A, Pachl J, Guerisse F, Elste T, Roessler M, Fritz H, Durnez P, Busch HJ, Inderbitzen B, Barbut D. Intra-arrest transnasal evaporative cooling: a randomized, prehospital, multicenter study (PRINCE: Pre-ROSC IntraNasal Cooling Effectiveness). Circulation. 2010 Aug 17;122(7):729-36. doi: 10.1161/CIRCULATIONAHA.109.931691. Epub 2010 Aug 2.
Other Identifiers
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COBRA Research Group
Identifier Type: OTHER
Identifier Source: secondary_id
OCCTAVI-I
Identifier Type: -
Identifier Source: org_study_id
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