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

Czech Technical University in Prague

Status: Invitation-only

Conditions: Mechanical Ventilation Complication; Ventilator-Induced Lung Injury

Treatments: Device: Electric impedance tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT06236685

AVIM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

General anesthesia

Experimental group

Description:

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.

Treatment:

Device: Electric impedance tomography

Intensive Care Unit

Experimental group

Description:

Patients ventilated in the ICU for various reasons will receive standard care, including advanced monitoring of mechanical ventilation.

Treatment:

Device: Electric impedance tomography