CompletedNot Applicable

Inspiratory Effort at Different Expiratory Cycling and Airway Resistance During Pressure Support Ventilation (CYCLOPES)

Italy24 participantsStarted 2023-08-01

Plain-language summary

The goal of this prospective interventional crossover randomized physiological study is to investigate the reliability of Pressure Muscle Index (PMI) - as an estimation of inspiratory effort - at different levels of expiratory cycling during pressure support ventilation. PMI will be compared with the esophageal pressure swing that is considered the gold standard technique. This study aims to answer to the following questions: * which is the optimal expiratory cycling threshold where PMI better correlates with the esophageal pressure swing? * what is the optimal correlation between the occlusion pressure (Poc) estimated by an expiratory occlusion manoeuvre and P0.1 with PMI obtained at various degrees of expiratory cycling threshold? * does airway resistance - evaluated by using esophageal pressure - correlate with the estimation of airway resistance on the pressure-time waveform by a high percentage of expiratory cycling mimicking the interrupter technique?

Who can participate

Age range

18 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: * Invasive mechanical ventilation in PSV * Presence of spontaneous breathing activity (ventilator triggering), since 6 hours and no longer than 72 hours after * Weaning from mechanical ventilation * Patient for full active management * Subject ≥ 18 years * Informed consent Exclusion Criteria * Age \<18 years old * Pregnancy * Active air leaks * Chronic Obstructive Pulmonary Disease and/or asthma * Moribund state * Neurological conditions potentially impairing the ventilatory drive (e.g. meningitis, encephalitis) and neuromuscular diseases impairing neuromuscular conduction (e.g. Guillain-Barre syndrome) * Extracorporeal membrane oxygenation (ECMO)

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

Pressure muscle index (PMI) as a bedside estimation of inspiratory effort at different expiratory cycling levels during different levels of pressure support.

Timeframe: After at least 6 hours after and within 72 hours since switch from controlled ventilation to pressure support ventilation.

Trial details

NCT IDNCT05952726

SponsorFondazione IRCCS San Gerardo dei Tintori

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-01

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