NCT01759563

Oxygenation of the Cerebrum and Cooling During TAVI - Part I

Safety and Feasibility Study of Nasopharyngeal Cooling (RhinoChill Device) During Transcutaneous Aortic Valve Implantation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Hasselt University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• TAVI
• Targeted Brain Cooling
• Neuroprotection

Interventions

Type	Name	Description
DEVICE	nasopharyngeal targeted brain cooling

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2013-01-03
• Last updated: 2013-01-03

Locations

1 site across 1 country: Belgium