TAVI Clinical Trial - Oxygenation of the Cerebrum & Cooling During TAVI -

Status Completed

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01759563
Study type	Interventional
Source	Hasselt University
Contact
Status	Completed
Phase	Phase 3
Start date	July 2012
Completion date	December 2012

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04310046` - Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial	N/A
Active, not recruiting	`NCT03058627` - Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation	N/A
Recruiting	`NCT05235555` - EffecTAVI Registry
Not yet recruiting	`NCT05914051` - PRELOAD-TAVI Trial	N/A
Active, not recruiting	`NCT03338582` - STIMTAVI : Evolution of Atrioventricular Conduction Disorders After TAVI	N/A
Active, not recruiting	`NCT03424941` - The TransCatheter Valve and Vessels Trial	N/A
Recruiting	`NCT06189976` - Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation	N/A
Active, not recruiting	`NCT04298593` - Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study	N/A
Completed	`NCT03966417` - Exercise Training After Transcatheter Aortic Valve Implantation	N/A
Completed	`NCT04286893` - Improved HRV, Inflammation Markers and Endothelial Function After TAVI
Recruiting	`NCT04831957` - Hypothyroidism After the TAVI Procedure in Elderly Patients	N/A
Not yet recruiting	`NCT05617196` - Virtual PREHAB Study for Patients Undergoing TAVI	N/A
Active, not recruiting	`NCT02700633` - Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI	N/A
Not yet recruiting	`NCT04083040` - Impact of Tilt Angle on Conduction Defects During Transcatheter Aortic Valve Implantation (TAVI)	N/A
Recruiting	`NCT03283501` - Revascularization After Transcatheter Aortic Valve Implantation (REVIVAL)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms