Anesthetic Safety of High-Frequency, Very-Low Tidal Volume Ventilation With Controlled Peak Press… (NCT07402798) | Clinical Trial Compass
CompletedNot Applicable
Anesthetic Safety of High-Frequency, Very-Low Tidal Volume Ventilation With Controlled Peak Pressure During Atrial Fibrillation Ablation
Spain52 participantsStarted 2025-05-01
Plain-language summary
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.
Who can participate
Age range
21 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* Vertigo.
* Ménière's disease.
* Narrow-angle glaucoma.
* Prior stroke with persistent neurological deficits.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Respiration related catheter stability during radiofrequency ablation.
Timeframe: Outcome measures were assessed intraprocedurally. Enrollement period was from May 2025 to September 2025.