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| ID | Type | Description | Link |
|---|---|---|---|
| COBRA Research Group | Other Identifier | Cardio+Brain Research Group UHasselt |
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Assessment of safety and feasibility of using a nasopharyngeal cooling technique to provide targeted brain cooling during percutaneous implantation of aortic valves. Was it possible to obtain brain temperatures below 34° within a reasonable time interval (max of 1hr) without delaying the procedure of valve implantation.
OCCTAVI-I Protocol
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm study | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nasopharyngeal targeted brain cooling | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome is the brain temperature obtained after initiation of nasopharyngeal cooling. Safety-outcome includes local or systemic side-effects of used cooling technique. | By the use of nasopharyngeal cooling, brain temperature will be decreased. Time to brain temperature below 34° will be recorded. Local side effects could occur due to the use of this specific nasopharyngeal cooling technique and systemic side effects (especially cardiovascular) could occur due to the initiation of hypothermia | Day1: start of cooling until brain temperature above 35.5°C |
| Measure | Description | Time Frame |
|---|---|---|
| changes in cerebral oxygenation (NIRS Fore-Sight technology) induced by targeted brain cooling | NIRS (or Near-infrared Spectroscopy) enables non-invasive monitoring of cerebral oxygen saturation during TAVI procedure and during the installation of targeted brain cooling. NIRS will be used as cerebral monitoring technique during this study protocol | Day 1: start of cooling until brain temperature above 35.5°C |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of targeted brain cooling on systemic core temperature | Induction of nasopharyngeal cooling and targeted brain cooling will result in systemic hypothermia. Systemic temperature (rectal temperature) will be recorded to assess the influence of nasopharyngeal cooling on systemic body temperature | Day 1: start of cooling until brain temperature above 35.5°C |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cathy De Deyne, Md, PhD | Ziekenhuis Oost-Limburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | 3600 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20679548 | Background | 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. |
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