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Clinical Trials in Italy / NCT07686315
Recruiting Observational

Advanced Respiratory Monitoring for Safer Mechanical Ventilation in Patients Without Respiratory Failure

NCT07686315 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2026-06-30
Last updated
2026-07-07

Condition(s) studied

Developing Acute Respiratory Distress Syndrome

Investigational drug(s) / intervention(s)

Advanced Non-Invasive Respiratory Monitoring

Advanced Non-Invasive Respiratory Monitoring: Continuous measurement and recording of airway pressure, esophageal pressure, inspiratory and expiratory flow, and electrical impedance tomography (EIT) data during the first 24 hours of mechanical ventilation. A nasogastric tube equipped with an esophageal balloon is placed alongside an EIT electrode belt. Monitoring is performed continuously off-line without altering standard clinical management. Residual respiratory function is also evaluated via spirometry and EIT prior to Intensive Care Unit (ICU) discharge.

Study summary

Patients admitted to the intensive care unit (ICU) and mechanically ventilated for reasons other than acute respiratory failure, such as coma, trauma, or sepsis, are at risk of developing acute respiratory distress syndrome (ARDS), which increases the duration of mechanical ventilation, mortality, and functional dependence at discharge.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Study Population Eligibility Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Inclusion Criteria: Adult patients +18 years. Undergoing invasive mechanical ventilation for reasons other than acute respiratory failure (such as coma, trauma, or sepsis). Initiation of monitoring within 24 hours of oro-tracheal intubation. Exclusion Criteria: Evidence of pneumothorax, pneumomediastinum, or subcutaneous emphysema. Pregnancy. Absolute contraindications to nasogastric tube placement. Absolute contraindications to electrical impedance tomography (EIT) monitoring.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Humanitas Research Hospital Milan Lombardy Recruiting

More Istituto Clinico Humanitas trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07686315 on ClinicalTrials.gov ↗ ← All trials in Italy