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

NCT05952726 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-19

No results posted yet for this study

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?

Conditions

Interventions

OTHER

Expiratory cycling change at different levels of pressure support ventilation

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.

Sponsors & Collaborators

  • Fondazione IRCCS San Gerardo dei Tintori

    lead OTHER

Principal Investigators

  • Emanuele Rezoagli, MD, PhD · University of Milano-Bicocca, Monza, Italy

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-02-01
Completion
2025-03-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05952726 on ClinicalTrials.gov