Advanced Respiratory Monitoring for Safer Mechanical Ventilation in Patients Without Respiratory Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The study population consists of adult patients admitted to the Intensive Care Unit (ICU) who require invasive mechanical ventilation for reasons entirely distinct from acute respiratory failure, such as coma, trauma, or sepsis. Eligible individuals must be enrolled and have monitoring initiated within the first 24 hours of oro-tracheal intubation. The cohort excludes patients with specific barotrauma complications, pregnant individuals, and those with absolute clinical contraindications to the required monitoring procedures.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Advanced Non-Invasive Respiratory Monitoring
Diagnostic testContinuous 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Adult patients without acute respiratory failure undergoing mechanical ventilation.1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Acute Respiratory Distress Syndrome (ARDS)
Association between ARDS development and advanced respiratory monitoring parameters derived from: Airway pressure/flow analysis: tidal volume/kg of ideal body weight, respiratory rate, plateau pressure, driving pressure, respiratory system compliance, and stress index. Esophageal pressure analysis: lung compliance, transpulmonary plateau pressure, transpulmonary driving pressure, and chest wall compliance. Electrical impedance tomography (EIT): regional compliance and tidal volume distribution homogeneity.
Time frame
Within the first 7 days of Intensive Care Unit (ICU) admission.Sponsors and contacts
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Source ClinicalTrials.gov