An interventional study of Electric impedance tomography in Mechanical Ventilation Complication and Ventilator-Induced Lung Injury, sponsored by Czech Technical University in Prague. Enrolling by invitation at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-28.
Sponsored by Czech Technical University in Prague · Not applicable, Interventional, and Diagnostic
The aim of this study is to collect synchronized data from multiple monitoring techniques of mechanical ventilation (pressure/flow waves from the ventilator, electrical impedance tomography - EIT, esophageal pressure, capnography) in patients ventilated either on intensive care units or during anesthesia and evaluate the data by detailed mathematical analysis, to test three hypotheses:
This study does not test any new or non-standard methods and does not in any way interfere with the course of treatment indicated by the clinician, apart from extending the monitoring techniques.
Mechanical ventilation is known to cause various complications, generally known as ventilator induced lung injury. Thus, detailed monitoring is essential. However, data interpretation is complicated in clinical practice. The investigators aim to collect synchronized data from multiple monitoring techniques of mechanical ventilation (pressure/flow waves from the ventilator, electrical impedance tomography - EIT, esophageal pressure, capnography) in patients ventilated either on intensive care units or during anesthesia and evaluate the data by detailed mathematical analysis. The results will be used to explore the complexity of seemingly simple and often used calculations describing the course of mechanical ventilation - mostly the expiratory time constant and amount of mechanical energy transferred to the lungs. The investigators primarily aim to test three hypotheses:
For this, the investigators plan to recruit 50 patients undergoing general anesthesia with controlled mechanical ventilation and 50 patients hospitalized on intensive care units. Monitoring of those patients will be protocolized and will in all cases include pressure/flow monitoring of the mechanical ventilator, capnography, and electrical impedance tomography. Esophageal pressure monitoring will be introduced where indicated by the clinician or where nasogastric tube insertion will be indicated (as the pressure can be measured by a combined catheter).
This study thus does not test any new or non-standard methods and does not in any way interfere with the course of treatment indicated by the clinician, apart from extending the monitoring techniques. Patient data will be anonymized and all the enrolled patients or their families will sign an informed consent as agreed by the ethical committee of our hospital.
120 studies on the registry are indexed under Ventilator-Induced Lung Injury; 39 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 74 interventional studies indexed under Ventilator-Induced Lung Injury.
Browse Ventilator-Induced Lung Injury studies →Czech Technical University in Prague is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
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Patients undergoing general anesthesia with mechanical ventilation will be monitored by electrical impedance tomography in addition to standard monitoring. Moreover, esophageal pressure catheter will be used in cases where indicated by clinician or in case of an indication of nasogastric tube, as esophageal pressure can be measured by a combined catheter.
Device: Electric impedance tomography
Patients ventilated in the ICU for various reasons will receive standard care, including advanced monitoring of mechanical ventilation.
Device: Electric impedance tomography
EIT is rarely used during general anesthesia for standard procedures. In the anesthesia arm, all patients will be monitored by EIT.
Also known as: EIT
Expiratory time constant
Time \[in seconds\], in which the lungs exhale 63% of the total volume.
Time frame: 2 minutes after an intervention or a change in the ventilator settings
Mechanical energy transferred to the lungs
Mechanical energy (alternatively referred to as mechanical work) \[in Joules\] is the energy delivered to the respiratory system during a single inspiration cycle.
Time frame: 2 minutes after an intervention or a change in the ventilator settings
Regional signals of electrical impedance tomography
Changes of regional signals of electrical impedance tomography throughout the respiratory cycle correspond to changes in lung aeration.
Time frame: 2 minutes after an intervention or a change in the ventilator settings
Plan to share: No — If any particularly interesting cases arise, the investigators plan to share the individual monitoring data together with the study protocol as anonymized case studies, either published or upon request to other researchers.
Started Apr 2024 (actual). Primary completion is estimated for Dec 2027, 44 months after the start.
Of 40 interventional studies with no phase under Ventilator-Induced Lung Injury, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 44 months is above that.
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Czech Technical University in Prague