Investigating inspiratory effort during pressure support ventilation
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)
NA · Fondazione IRCCS San Gerardo dei Tintori · NCT05952726
This study is testing a new way to measure how hard patients with breathing problems are working to breathe while on a ventilator, to see if it matches up with the standard method used.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS San Gerardo dei Tintori (other) |
| Locations | 1 site (Monza, MB) |
| Trial ID | NCT05952726 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the reliability of the Pressure Muscle Index (PMI) as a measure of inspiratory effort at various levels of expiratory cycling during pressure support ventilation in patients with respiratory failure. It will compare PMI with esophageal pressure swings, which are considered the gold standard for assessing inspiratory effort. The study will also explore the optimal expiratory cycling threshold for correlating PMI with esophageal pressure and assess airway resistance using esophageal pressure measurements. The findings could enhance the understanding of patient self-inflicted lung injury during mechanical ventilation.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are on invasive mechanical ventilation with spontaneous breathing activity and are in the process of weaning from mechanical ventilation.
Not a fit: Patients under 18 years old, those with chronic obstructive pulmonary disease or asthma, and individuals with neurological conditions affecting ventilatory drive may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of patients on mechanical ventilation by providing a reliable method to assess inspiratory effort and prevent lung injury.
How similar studies have performed: While the approach of using PMI is established, the specific correlation with esophageal pressure at varying expiratory cycling levels is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Monza, MB
- Fondazione IRCCS San Gerardo dei Tintori — Monza, MB, Italy (RECRUITING)
Study contacts
- Principal investigator: Emanuele Rezoagli, MD, PhD — University of Milano-Bicocca, Monza, Italy
- Study coordinator: Emanuele Rezoagli, MD, PHD
- Email: emanuele.rezoagli@unimib.it
- Phone: 0392332127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Respiratory Failure, pressure support, esophageal pressure, pressure muscle index, expiratory cycling, inspiratory effort, plateau pressure, transpulmonary pressure