CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Expiratory cycling change at different levels of pressure support ventilationother
Likely dose
Not stated in record
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Search/NCT05952726
NCT05952726N/ACompleted

Inspiratory Effort and Airway Resistance Assessment During Assisted Mechanical Ventilation in Critically Ill Patients at Different Levels of Expiratory Cycling: a Cross-over Randomized Physiological Study (CYCLOPES)

Fondazione IRCCS San Gerardo dei Tintori·interventional·Posted Jul 19, 2023·Updated Sep 19, 2025

In Brief

A clinical study evaluating Expiratory cycling change at different levels of pressure support ventilation for Respiratory Failure. Completed, enrolled 24 participants across 1 site.

Detailed 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?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedJul 19, 2023
Enrollment StartAug 1, 2023
Primary CompletionFeb 1, 2025
Study CompletionMar 1, 2025
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 3.0 years ago

Interventions

Expiratory cycling change at different levels of pressure support ventilationother

Four different levels of expiratory cycling will be randomly applied at 3 different degrees of pressure support. Three end-inspiratory and three end-expiratory occlusion manoeuvres will be carried out at the end of 10 minute steps of ventilation during each set value expiratory cycling and pressure support level. Total study time will be about 120 minutes. Levels of pressure support wil be clinical pressure support ± 4 cmH2O; expiratory cycling percentages applied for each pressure support step will be 15%, 30%, 45% and 60% of peak inspiratory flow.