Effect of Mechanical Ventilation on Cardiac RF Ablation

NCT ID: NCT06986577

Last Updated: 2026-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-30

Study Completion Date

2026-02-27

Brief Summary

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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

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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

Conditions

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Radiofrequency Catheter Ablation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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1) Lung protective mechanical ventilation

Mechanical ventilation with 7-9 ml tidal volume during RF

No interventions assigned to this group

2) Low tidal volume high frequency ventilation

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

No interventions assigned to this group

3) Apnea ventilation

Apne ventilastion during RF

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

0 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Izmir City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gözde Gürsoy Çirkinoğlu

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gözde Gürsoy Çirkinoğlu, MD

Role: PRINCIPAL_INVESTIGATOR

Izmir City Hospital, Anesthesiology and Reanimation Department

Halide Hande Sahinkaya, MD

Role: STUDY_CHAIR

Izmir City Hospital, Anesthesiology and Reanimation Department

Zeki Tuncel Tekgül, Prof. Dr.

Role: STUDY_CHAIR

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

Cem Karadeniz, Prof. Dr

Role: STUDY_CHAIR

Izmir Katip Celebi University Medical Faculty, Pediatric Cardiology Department

Locations

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İzmir City Hospital

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 35333095 (View on PubMed)

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.

Reference Type RESULT
PMID: 30573114 (View on PubMed)

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.

Reference Type RESULT
PMID: 34137629 (View on PubMed)

Other Identifiers

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Mechanical Ventilation

Identifier Type: -

Identifier Source: org_study_id

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