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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01759563
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : January 3, 2013
Information provided by (Responsible Party):
Prof Dr Cathy De Deyne, Ziekenhuis Oost-Limburg

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.

Condition or disease Intervention/treatment Phase
TAVI Targeted Brain Cooling Neuroprotection Device: nasopharyngeal targeted brain cooling Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Feasibility Study of Nasopharyngeal Cooling (RhinoChill Device) During Transcutaneous Aortic Valve Implantation
Study Start Date : July 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
single arm study Device: nasopharyngeal targeted brain cooling
Other Name: RhinoChill Device, BeneChill company

Primary Outcome Measures :
  1. Primary outcome is the brain temperature obtained after initiation of nasopharyngeal cooling. Safety-outcome includes local or systemic side-effects of used cooling technique. [ Time Frame: 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 :
  1. changes in cerebral oxygenation (NIRS Fore-Sight technology) induced by targeted brain cooling [ Time Frame: 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

Other Outcome Measures:
  1. Influence of targeted brain cooling on systemic core temperature [ Time Frame: Day 1: start of cooling until brain temperature above 35.5°C ]
    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

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • pts eligible for TAVI interventions

Exclusion Criteria:

  • urgent intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01759563

Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
Sponsors and Collaborators
Hasselt University
Principal Investigator: Cathy De Deyne, Md, PhD Ziekenhuis Oost-Limburg