跳至主要内容
临床试验/NCT07402798
NCT07402798已完成不适用

Respiration-induced Ablation Catheter Displacement and Anesthetic Safety of High-Frequency, Very-Low Tidal Volume Ventilation With Controlled Peak Pressure During Atrial Fibrillation Ablation: An Observational Crossover Pilot Study

Centro Medico Teknon1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Respiration related catheter stability during radiofrequency ablation.

研究概览

简要总结

This prospective, observational, within-subject crossover pilot study evaluates the impact of a high-frequency, very-low tidal volume ventilation strategy with controlled peak inspiratory pressure (HFvLTV-cPP) on respiration-induced ablation catheter displacement during atrial fibrillation (AF) radiofrequency ablation performed under general anesthesia. In the same patients, standard mechanical ventilation is compared with HFvLTV-cPP during the ablation phase to quantify catheter stability under matched contact force conditions. Secondary objectives include assessment of arterial carbon dioxide levels, ventilatory mechanics, hemodynamic parameters, anesthetic requirements, and post-anesthesia recovery outcomes. The study aims to determine whether limiting peak inspiratory pressure while using high respiratory rates and ultra-low tidal volumes improves catheter stability while maintaining acceptable gas exchange, cardiopulmonary safety, and postoperative recovery profiles.

详细描述

Catheter ablation is an established treatment for symptomatic atrial fibrillation (AF); however, recurrence after radiofrequency ablation remains frequent, with 30-40% of patients experiencing arrhythmia recurrence after a first procedure. Effective lesion formation depends on adequate catheter-tissue contact force and stability. General anesthesia improves catheter contact compared with conscious sedation by reducing thoracic motion, yet standard mechanical ventilation does not fully eliminate respiration-induced catheter displacement.

High-frequency jet ventilation has been shown to improve catheter stability but requires specialized equipment. As an alternative, high-frequency low tidal volume ventilation (HFLTV) using conventional anesthesia ventilators has been associated with reduced thoracic motion, improved catheter stability, and shorter ablation times. Nevertheless, sustained high respiratory rates may increase intrinsic positive end-expiratory pressure (PEEP), mechanical power, intrathoracic pressure, and carbon dioxide retention, and the safety profile of these strategies has not been fully characterized.

In addition, when tidal volume approaches anatomic and circuit dead space, effective alveolar ventilation decreases and PaCO₂ may rise, while increasing respiratory rate disproportionately increases mechanical power delivered to the respiratory system. Explicit limitation of peak inspiratory pressure, a factor rarely addressed in previous studies, may reduce ventilatory energy transfer, minimize catheter motion, and mitigate adverse cardiopulmonary effects.

High-frequency very-low tidal volume ventilation with controlled peak inspiratory pressure (HFvLTV-cPP) combines ultra-low tidal volumes with strict limitation of peak inspiratory pressure (≤ 20 cmH₂O) to minimize respiration-induced catheter displacement while preserving gas exchange, limiting mechanical power, and maintaining hemodynamic stability, accepting brief and controlled permissive hypercapnia.

Since 2021, HFLTV has been routinely implemented during AF ablation at the Instituto del Corazón (ICOR), Centro Médico Teknon (Barcelona, Spain). However, no prior studies have systematically evaluated a protocol incorporating explicit peak inspiratory pressure control, nor have they comprehensively assessed anesthetic recovery and post-anesthesia safety outcomes.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
21 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 21-85 years.
  • Diagnosed with paroxysmal, persistent, or permanent atrial fibrillation (AF).
  • Scheduled for radiofrequency ablation (RFA) under general anesthesia.
  • Patients undergoing repeat ablation procedures included for evaluation of ventilatory, anesthetic, and post-anesthesia recovery parameters.
  • Patients undergoing repeat ablation procedures excluded from analyses related to procedural efficacy outcomes.

排除标准

  • Left or right ventricular dysfunction.
  • Severe tricuspid regurgitation.
  • Severe pulmonary hypertension.
  • Severe chronic obstructive pulmonary disease (COPD) with evidence of auto-positive end-expiratory pressure.
  • Uncontrolled severe asthma.
  • Chronic metabolic acidosis with associated hyperkalemia.
  • Severe migraine disorders.
  • Trigeminal neuralgia.
  • Atypical facial pain.
  • Advanced hydrocephalus.
  • Presence of ventriculoperitoneal shunt.
  • Parkinson's disease.
  • Epilepsy.
  • Ménière's disease.
  • Narrow-angle glaucoma.
  • Prior stroke with persistent neurological deficits.

结局指标

主要结局

Respiration related catheter stability during radiofrequency ablation.

时间窗: Outcome measures were assessed intraprocedurally. Enrollement period was from May 2025 to September 2025.

Respiration-related catheter stability was assessed quantitatively as catheter displacement (millimeters) during radiofrequency ablation. Catheter displacement was measured under standard mechanical ventilation and after 15 minutes of high-frequency, very low-tidal-volume ventilation with continuous positive pressure (HFvLTV-cPP).

次要结局

未报告次要终点

研究者

发起方
Centro Medico Teknon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Berruezo, MD, PhD

Carlos Ramírez-Paesano,MD,PhD

Centro Medico Teknon

研究点 (1)

Loading locations...

相似试验