Clinical trial NCT01759563: Oxygenation of the Cerebrum and Cooling During TAVI - Part I
Official title: Safety and Feasibility Study of Nasopharyngeal Cooling (RhinoChill Device) During Transcutaneous Aortic Valve Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: TAVI
Targeted Brain Cooling
Neuroprotection
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

* 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

Eligibility criteria: Inclusion Criteria:

* pts eligible for TAVI interventions

Exclusion Criteria:

* urgent intervention

Primary outcomes:
measure: Primary outcome is the brain temperature obtained after initiation of nasopharyngeal cooling. Safety-outcome includes local or systemic side-effects of used cooling technique.
timeFrame: Day1: start of cooling until brain temperature above 35.5°C
Secondary outcomes:
measure: changes in cerebral oxygenation (NIRS Fore-Sight technology) induced by targeted brain cooling
timeFrame: Day 1: start of cooling until brain temperature above 35.5°C
Other outcomes:
measure: Influence of targeted brain cooling on systemic core temperature
timeFrame: Day 1: start of cooling until brain temperature above 35.5°C
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Cathy De Deyne, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.