Clinical trial NCT06986577: Effect of Mechanical Ventilation on Cardiac RF Ablation
Official title: Evaluation of Mechanical Ventilation Methods Applied During the Procedure in Pediatric Cardiac Radiofrequency Ablation Interventions: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Radiofrequency Catheter Ablation
Keywords: mechanical ventilation
cardiac radiofrequency ablation
pediatric arryhtmia
Lead sponsor: Izmir City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-23
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: During the 3-month period, cardiac paediatric patients undergoing radiofrequency ablation under general anaesthesia in the catheterisation laboratory will be analysed

Brief summary: The aim of this study is to describe the results of cardiac radiofrequency ablation under general anesthesia.

to evaluate mechanical ventilation methods in pediatric patients. The main questions it aims to answer are

1. Whether lower tidal volume high frequency mechanical ventilation effects the success of radiofrequency ablation in pediatric cardiac arryhtmia patient?
2. The effect of mechanical ventilation strategies on the number of effective lesions, radiofrequency ablation time and arrhythmia recurrence in the first month

Detailed description: Radiofrequency ablation (RF) is an effective method for the threatment of cardiac arrhythmias in pediatric patients. General anaesthesia and mechanical ventilation is the most common anesthesia management for pediatric arrhythmia patients. During the prosedure, thoracic excursion results in displacement of the catheter and disrupts the catheter stability which is crucial for quality of contact force (CF), sufficient ablation and safety. To minimize the thoracic excursion, high frequency low tidal volume ventilation and apnea ventilation may be needed during radiofrequency ablation. According to investigators knowledge there are studies about ventilatory strategies in adult patients who underwent cardiac radiofrequency ablation. However, there are no studies corcerning pediatric patients. In this study investigators aimed to investigate best ventilatory strategy for minimize thoracic excursion in pediatric patients with general anaesthesia. In this study investigators are going to observe 3 different ventilation strategies on radiofrequency ablation.

1. Lung protective mechanical ventilation with 7-9 ml/kg tidal volume,
2. Low tidal volume (4 ml/kg) high frequency mechanical ventilation
3. Apnea ventilation during radiofrequency ablation

Eligibility criteria: Inclusion Criteria:

* Between 0-18 years
* Paediatric surgery under general anaesthesia at Izmir City Hospital in the last 3 months since the date undergoing cardiac radiofrequency ablation procedure
* Procedures were performed with catheters with contract force measurement feature patients with

Exclusion Criteria:

* Patients with maintenance other than inhalation anaesthesia
* Patients whose anaesthesia method is changed during the procedure
* Patients with airway complications
* Development of haemodynamic instability during the procedure
* Patient with a history of previous cardiac surgery
* Presence of additional cardiac disease, advanced connective tissue disease, connective tissue disease, mitochondrial muscle disease

Primary outcomes:
measure: Contact force
timeFrame: intraprosedural
Secondary outcomes:
measure: Lession count
timeFrame: intraprosedural
measure: Time
timeFrame: intraprosedural
Other outcomes:
Locations:
Study officials:
affiliation: Izmir City Hospital, Anesthesiology and Reanimation Department
name: Gözde Gürsoy Çirkinoğlu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Izmir City Hospital, Anesthesiology and Reanimation Department
name: Halide Hande Sahinkaya, MD
role: STUDY_CHAIR
affiliation: University of Health Sciences, Izmir City Hospital, Anesthesiology and Reanimation Department
name: Zeki Tuncel Tekgül, Prof. Dr.
role: STUDY_CHAIR
affiliation: Izmir Katip Celebi University Medical Faculty, Pediatric Cardiology Department
name: Cem Karadeniz, Prof. Dr
role: STUDY_CHAIR
References:
citation: Osorio J, Varley A, Kreidieh O, Godfrey B, Schrappe G, Rajendra A, Silverstein J, Romero J, Rodriguez D, Morales G, Zei P. High-Frequency, Low-Tidal-Volume Mechanical Ventilation Safely Improves Catheter Stability and Procedural Efficiency During Radiofrequency Ablation of Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2022 Apr;15(4):e010722. doi: 10.1161/CIRCEP.121.010722. Epub 2022 Mar 25. No abstract available.
citation: Sivasambu B, Hakim JB, Barodka V, Chrispin J, Berger RD, Ashikaga H, Ciuffo L, Tao S, Calkins H, Marine JE, Trayanova N, Spragg DD. Initiation of a High-Frequency Jet Ventilation Strategy for Catheter Ablation for Atrial Fibrillation: Safety and Outcomes Data. JACC Clin Electrophysiol. 2018 Dec;4(12):1519-1525. doi: 10.1016/j.jacep.2018.08.016. Epub 2018 Nov 1.
citation: Janson CM, Shah MJ, Kennedy KF, Iyer VR, Sweeten TL, Glatz AC, Steven JM, O'Byrne ML. Comparison of Outcomes of Pediatric Catheter Ablation by Anesthesia Strategy: A Report From the NCDR IMPACT Registry. Circ Arrhythm Electrophysiol. 2021 Jul;14(7):e009849. doi: 10.1161/CIRCEP.121.009849. Epub 2021 Jun 17.