Oxygenation of the Cerebrum and Cooling During TAVI - Part I (OCCTAVI-I)

Hasselt University

Status and phase: Completed; Phase 3

Conditions: Neuroprotection; TAVI; Targeted Brain Cooling

Treatments: Device: nasopharyngeal targeted brain cooling

Study type: Interventional

Funder types: Other

Identifiers

NCT01759563

OCCTAVI-I

COBRA Research Group (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 6 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• pts eligible for TAVI interventions

Exclusion criteria

• urgent intervention

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

single arm study

Other group

Treatment:

Device: nasopharyngeal targeted brain cooling