Optimizing the Assessment of Mechanical Ventilation by Integrating Advanced Monitoring Techniques [AVIM]

Mechanical Ventilation Complication Clinical Trial

— AVIM  

Official title:

Optimizing the Assessment of Mechanical Ventilation by Integrating Advanced Monitoring Techniques

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06236685
• Other study ID #: AVIM
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2027

Study information

• Verified date: February 2024
• Source: Czech Technical University in Prague
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

1. Various published methods of calculation of the expiratory time constant provide different results in most cases.

2. Inhomogeneous ventilation (as described by EIT) affects the form of the expiratory flow curve and thus the calculated expiratory time constants.

3. The calculation of mechanical energy transferred to the lungs is affected by the chosen technique and length of the inspiratory pause maneuver.

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.

Description:

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:

1. Various published methods of calculation of the expiratory time constant provide different results in most cases.

2. Inhomogeneous ventilation (as described by EIT) affects the form of the expiratory flow curve and thus the calculated expiratory time constants.

3. The calculation of mechanical energy transferred to the lungs is affected by the chosen technique and length of the inspiratory pause maneuver.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• mechanical ventilation for anesthesia or in intensive care unit

Exclusion Criteria:

• disagreement with enrollment or incapacity to understand the patient information leaflet

• contraindications to electric impedance tomography (skin lesions in the place of electrode placement etc.)

• necessity to use a defined ventilator setting outside the study protocol

Related Conditions & MeSH terms

• Lung Injury
• Mechanical Ventilation Complication
• Ventilator-Induced Lung Injury

Intervention

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.

Locations

Country	Name	City	State
Czechia	Military University Hospital	Praha

Sponsors (2)

Lead Sponsor	Collaborator
Czech Technical University in Prague	Military University Hospital, Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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