Effect of Mechanical Ventilation on Cardiac RF Ablation

NCT06986577 | Active Not Recruiting

• 1 other identifier: Mechanical Ventilation
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Radiofrequency Catheter Ablation

Keywords

mechanical ventilation; cardiac radiofrequency ablation; pediatric arryhtmia

Outcome Measures

Primary Outcomes (1)

• Contact force

  continuously measured through the catheter

  intraprosedural

Secondary Outcomes (2)

• Lession count

  intraprosedural

• Time

  intraprosedural

Study Arms (3)

1) Lung protective mechanical ventilation

Mechanical ventilation with 7-9 ml tidal volume during RF

2) Low tidal volume high frequency ventilation

Mechanical ventilation with 4 ml tidal volume with high frequency during RF

3) Apnea ventilation

Apne ventilastion during RF

Eligibility Criteria

• Age: 0 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir City Hospital: lead

Study Sites (1)

İzmir City Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 35333095 RESULT

• 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.

  PMID: 30573114 RESULT

• 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.

  PMID: 34137629 RESULT

Study Officials

• Gözde Gürsoy Çirkinoğlu, MD

  Izmir City Hospital, Anesthesiology and Reanimation Department

  PRINCIPAL INVESTIGATOR

• Halide Hande Sahinkaya, MD

  Izmir City Hospital, Anesthesiology and Reanimation Department

  STUDY CHAIR

• Zeki Tuncel Tekgül, Prof. Dr.

  University of Health Sciences, Izmir City Hospital, Anesthesiology and Reanimation Department

  STUDY CHAIR

• Cem Karadeniz, Prof. Dr

  Izmir Katip Celebi University Medical Faculty, Pediatric Cardiology Department

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: January 30, 2025
• Primary Completion: February 10, 2026
• Study Completion: February 27, 2026
• Last Updated: January 29, 2026

Record last verified: 2025-01

Locations

TU (1)