None listed
Conditions
Brief summary
Atrial fibrillation (AF) is the most frequently observed sustained arrhythmia in cardiology. Treatment of AF is increasingly based on a procedure called AF ablation, which involves electrical isolation of the pulmonary veins. Currently, AF ablation takes about 2-3 hours. The technique involves the introduction of an ablation catheter into the patient's left atrium, under general anaesthesia and endotracheal intubation, which will allow linear lesions to be made by applying a radiofrequency (RF) current. In the patient's atrium, the catheter is visualised on a screen by a programme allowing a 3-dimensional reconstruction of the cardiac cavities and the visualisation of the catheter in real time. To ensure the creation of sufficiently deep ablation lesions, the stability of the catheter during firing is important. The less the catheter moves during the RF shot, the more the energy delivered will be concentrated on a small area and the lesion will be considered effective. Patients are anaesthetised during the procedure and must be ventilated by a ventilator. Part of the catheter movement therefore comes from the ventilatory cycles. Hypothesis By using a "high frequency jet ventilation" mode, the chest movements related to air insufflations by the ventilator are almost abolished. This should improve catheter stability, allowing fewer radiofrequency shots to be taken and less time to stabilise the catheter. This should reduce the duration of the procedures, which may allow more procedures to be performed. This may also be an advantage for the patient (shorter general anaesthesia and therefore less risk of complications, less risk of thrombus formation on the catheters as they will remain in the heart chambers for less time). The quality of the ablation lesions should be improved by the stability of the catheter, which may result in easier and longer lasting vein isolation. The rare complications associated with JET ventilation are related to the possibility of generating overpressure in the airways (risk of pulmonary barotrauma) and the impossibility of checking the outflow of CO2 at the tube, with possible hypercapnia.
Interventions
- The intervention consists of the use of high frequency jet ventilation as a primary mode of ventilation after transseptal puncture, when performing a percutaneous pulmonary vein ablation procedure in the context of atrial fibrillation. Its settings will be as follows (Starting working pressure 0.02 bar/kg, Rate 150/minute, FiO2 50%, I/T 30%).
After induction of general anaesthesia, intubation will be followed by insertion of a LaserJet catheter (Acutronic Medical Systems, Hirzel, Schweiz) int
- The intervention consists of the use of high frequency jet ventilation as a primary mode of ventilation after transseptal puncture, when performing a percutaneous pulmonary vein ablation procedure in the context of atrial fibrillation. Its settings will be as follows (Starting working pressure 0.02 bar/kg, Rate 150/minute, FiO2 50%, I/T 30%). After induction of general anaesthesia, intubation will be followed by insertion of a LaserJet catheter (Acutronic Medical Systems, Hirzel, Schweiz) into the endotracheal tube to perform jet ventilation. Arterial blood gas and EtCO2 measurement via 5 manual ventilations will be performed immediately after transseptal atrial puncture and before removal of the left atrial ablation catheter. The duration of the procedure is defined by the time between transseptal puncture of the left atrium and removal of the ablation catheter from the left atrium, once all four pulmonary veins have been radiofrequently isolated. No maximum time limit was defined for the procedure. The mean estimate of procedural time used for statistical power and sample calculation was 120 minutes per procedure. Patients in this arm of the study will also receive a 5 ml 0.9% NaCl aerosol in the recovery room after the procedure. - A printed and electronic protocol for the management of ventilation according to the patient's assigned arm will be immediately available in the cardiac catheterisation room. - The procedure will be performed by a specialist anaesthesiologist trained in the use of high frequency jet ventilation. - The procedure will be performed during an inpatient stay for a pulmonary vein ablation procedure in the context of atrial fibrillation. - One procedure per patient - CHU UCL Namur, Godinne site, a tertiary university teaching hospital. The cardiological intervention will take place in a cardiac catheterisation room dedicated to the performance of interventional rhythmology procedures. Adaptation of the procedure: - The working pressure of the jet ventilation will be adapted to the EtCO2, by measuring the EtCO2 during the gas measurements described above and every 30 minutes after the start of the jet ventilation.
Sponsors
Adrien Maseri
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age > 18 years Documentation of atrial fibrillation for which an indication for ablation has been made by a cardiologist and accepted by the patient Written agreement to the research protocol
Exclusion criteria
- Extreme COPD (GOLD 4) - Lung transplant patients - Patients with cystic fibrosis, primary ciliary dyskinesia or other conditions involving mucociliary escalator fragility - Corrected complex congenital heart disease - Morbid obesity (BMI >40) - Patient allergic to soy ( contraindicating the use of propofol necessary for induction and maintenance of anaesthesia in high frequency jet-ventilation
Outcome results
None listed