Oxygenation of the Cerebrum and Cooling During TAVI - Part I

Phase 3

Completed

• Conditions: TAVI; Targeted Brain Cooling; Neuroprotection
• Interventions: Device: nasopharyngeal targeted brain cooling

• Registration Number: NCT01759563
• Lead Sponsor: Hasselt University

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

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2012-12-27
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-02
• Last Update Submitted: 2013-01-02
• Study First Posted: 2013-01-03
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• pts eligible for TAVI interventions

Exclusion Criteria

• urgent intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm study	nasopharyngeal targeted brain cooling	-

Primary Outcome Measures

Name	Time	Method
Primary outcome is the brain temperature obtained after initiation of nasopharyngeal cooling. Safety-outcome includes local or systemic side-effects of used cooling technique.	Day1: start of cooling until brain temperature above 35.5°C	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

Secondary Outcome Measures

Name	Time	Method
changes in cerebral oxygenation (NIRS Fore-Sight technology) induced by targeted brain cooling	Day 1: start of cooling until brain temperature above 35.5°C	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

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium