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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof Dr Cathy De Deyne, Ziekenhuis Oost-Limburg
ClinicalTrials.gov Identifier:
NCT01759563
First received: December 27, 2012
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
TAVI
Targeted Brain Cooling
Neuroprotection
Device: nasopharyngeal targeted brain cooling
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Feasibility Study of Nasopharyngeal Cooling (RhinoChill Device) During Transcutaneous Aortic Valve Implantation

Further study details as provided by Hasselt University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Influence of targeted brain cooling on systemic core temperature [ Time Frame: Day 1: start of cooling until brain temperature above 35.5°C ] [ Designated as safety issue: No ]
    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


Enrollment: 6
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
single arm study Device: nasopharyngeal targeted brain cooling
Other Name: RhinoChill Device, BeneChill company

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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pts eligible for TAVI interventions

Exclusion Criteria:

  • urgent intervention
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01759563

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

Publications:
Responsible Party: Prof Dr Cathy De Deyne, Prof Dr Jo Dens, Ziekenhuis Oost-Limburg
ClinicalTrials.gov Identifier: NCT01759563     History of Changes
Other Study ID Numbers: OCCTAVI-I, COBRA Research Group
Study First Received: December 27, 2012
Last Updated: January 2, 2013
Health Authority: Belgium: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014