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NCT Number: NCT06986577

Effect of Mechanical Ventilation on Cardiac RF Ablation

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

0 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

İzmir City Hospital

Izmir, Turkey (Türkiye)

About this study

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.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Contact force

    Time frame: intraprosedural

    continuously measured through the catheter

Secondary outcomes

  1. Lession count

    Time frame: intraprosedural

    number of successful lesions

  2. Time

    Time frame: intraprosedural

    RF time

Sponsors and collaborators

Lead sponsor

Izmir City Hospital

Other Gov

Registry information

Official study title

Evaluation of Mechanical Ventilation Methods Applied During the Procedure in Pediatric Cardiac Radiofrequency Ablation Interventions: Prospective Observational Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 23, 2025
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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