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| Name | Class |
|---|---|
| Military University Hospital, Prague | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General anesthesia | Experimental | 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. |
|
| Intensive Care Unit | Experimental | Patients ventilated in the ICU for various reasons will receive standard care, including advanced monitoring of mechanical ventilation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electric impedance tomography | Device | EIT is rarely used during general anesthesia for standard procedures. In the anesthesia arm, all patients will be monitored by EIT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Expiratory time constant | Time [in seconds], in which the lungs exhale 63% of the total volume. | 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. | 2 minutes after an intervention or a change in the ventilator settings |
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| Measure | Description | Time Frame |
|---|---|---|
| Regional signals of electrical impedance tomography | Changes of regional signals of electrical impedance tomography throughout the respiratory cycle correspond to changes in lung aeration. | 2 minutes after an intervention or a change in the ventilator settings |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karel RoubÃk, prof. | Czech Technical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Military University Hospital | Prague | 16902 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30236123 | Background | Karagiannidis C, Waldmann AD, Roka PL, Schreiber T, Strassmann S, Windisch W, Bohm SH. Regional expiratory time constants in severe respiratory failure estimated by electrical impedance tomography: a feasibility study. Crit Care. 2018 Sep 21;22(1):221. doi: 10.1186/s13054-018-2137-3. | |
| 7774225 | Background | Brunner JX, Laubscher TP, Banner MJ, Iotti G, Braschi A. Simple method to measure total expiratory time constant based on the passive expiratory flow-volume curve. Crit Care Med. 1995 Jun;23(6):1117-22. doi: 10.1097/00003246-199506000-00019. |
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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.
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The study will be conducted on patients provided with mechanical ventilation either on intensive care units or during anesthesia. Extended monitoring of ventilation, including electric impedance tomography and esophageal pressure readings will be applied.
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| 30204464 | Background | Candik P, Rybar D, Depta F, Sabol F, Kolesar A, Galkova K, Torok P, Donicova V, Imrecze S, Nosal M, Donic V. Relationship between dynamic expiratory time constant tau(edyn) and parameters of breathing cycle in pressure support ventilation mode. Physiol Res. 2018 Dec 18;67(6):875-879. doi: 10.33549/physiolres.933750. Epub 2018 Sep 11. |
| 27923979 | Background | Henderson WR, Molgat-Seon Y, Vos W, Lipson R, Ferreira F, Kirby M, Holsbeke CV, Dominelli PB, Griesdale DE, Sekhon M, Coxson HO, Mayo J, Sheel AW. Functional respiratory imaging, regional strain, and expiratory time constants at three levels of positive end expiratory pressure in an ex vivo pig model. Physiol Rep. 2016 Dec;4(23):e13059. doi: 10.14814/phy2.13059. |
| 22898553 | Background | Vogt B, Pulletz S, Elke G, Zhao Z, Zabel P, Weiler N, Frerichs I. Spatial and temporal heterogeneity of regional lung ventilation determined by electrical impedance tomography during pulmonary function testing. J Appl Physiol (1985). 2012 Oct;113(7):1154-61. doi: 10.1152/japplphysiol.01630.2011. Epub 2012 Aug 16. |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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