Oxygenation of the Cerebrum and Cooling During TAVI - Part I

TAVI Clinical Trial

— OCCTAVI-I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759563
• Other study ID #: OCCTAVI-I
• Secondary ID: COBRA Research G
• Status: Completed
• Phase: Phase 3
• First received: December 27, 2012
• Last updated: January 2, 2013
• Start date: July 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• pts eligible for TAVI interventions

Exclusion Criteria:

• urgent intervention

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neuroprotection
• Targeted Brain Cooling
• TAVI

Intervention

Device:
• nasopharyngeal targeted brain cooling

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Castrén 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, Guérisse 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	Yes
Secondary	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	No