Mechanical Ventilation ComplicationAVIMNCT06236685
Optimizing the Assessment of Mechanical Ventilation by Integrating Advanced Monitoring Techniques [AVIM]
A study testing Electric impedance tomography in people with Mechanical Ventilation Complication and Ventilator-Induced Lung Injury, run by Czech Technical University in Prague at 1 site in Czechia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Ventilator-Induced Lung Injury
- What is being tested?
- Electric impedance tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 22 Apr 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mechanical ventilation for anesthesia or in intensive care unit
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimizing the Assessment of Mechanical Ventilation by Integrating Advanced Monitoring Techniques
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:
- Various published methods of calculation of the expiratory time constant provide different results in most cases.
- Inhomogeneous ventilation (as described by EIT) affects the form of the expiratory flow curve and thus the calculated expiratory time constants.
- 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.
Read the detailed 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:
- Various published methods of calculation of the expiratory time constant provide different results in most cases.
- Inhomogeneous ventilation (as described by EIT) affects the form of the expiratory flow curve and thus the calculated expiratory time constants.
- 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.
- Being tested
- Electric impedance tomography
- Keywords
- electrical impedance tomography, expiratory time constant, mechanical energy, lung protective ventilation, ventilator-induced lung injury, expiratory flow, inspiratory hold maneuver
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric impedance tomographyDevice
Also called EIT
EIT is rarely used during general anesthesia for standard procedures. In the anesthesia arm, all patients will be monitored by EIT.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Electric impedance tomography |
| Intensive Care Unit | Experimental | Patients ventilated in the ICU for various reasons will receive standard care, including advanced monitoring of mechanical ventilation. Receives: Device: Electric impedance tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expiratory time constant
Time [in seconds], in which the lungs exhale 63% of the total volume.
Measured: 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.
Measured: 2 minutes after an intervention or a change in the ventilator settings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start22 Apr 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Collaborators
- Military University Hospital, Prague
- Responsible party
- Sponsor
- Investigators
- Karel Roubík, prof., Study director, Czech Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236685
- Sponsor's protocol ID
- AVIM
- Acronym
- AVIM
- Status last verified
- Jun 2024
- First submitted
- 24 Jan 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 30236123Brunner 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.
PubMed 7774225Candik 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.
PubMed 30204464Henderson 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.
PubMed 27923979Vogt 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.
PubMed 22898553
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Assessment of Mechanical Ventilation by Integrating Advanced Monitoring Techniques
- ClinicalTrials.gov ID
- NCT06236685
- Acronym / sponsor ID
- AVIM / AVIM
- Keywords
- electrical impedance tomography, expiratory time constant, mechanical energy, lung protective ventilation, ventilator-induced lung injury, expiratory flow, inspiratory hold maneuver
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Collaborators
- Military University Hospital, Prague
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Various published methods of calculation of the expiratory time constant provide different results in most cases.
- Inhomogeneous ventilation (as described by EIT) affects the form of the expiratory flow curve and thus the calculated expiratory time constants.
- 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.
Detailed 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:
- Various published methods of calculation of the expiratory time constant provide different results in most cases.
- Inhomogeneous ventilation (as described by EIT) affects the form of the expiratory flow curve and thus the calculated expiratory time constants.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | Experimental | Device: Electric impedance tomographyPatients 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 | Device: Electric impedance tomographyPatients ventilated in the ICU for various reasons will receive standard care, including advanced monitoring of mechanical ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mechanical ventilation for anesthesia or in intensive care unit
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electric impedance tomographyAlso: EITEIT is rarely used during general anesthesia for standard procedures. In the anesthesia arm, all patients will be monitored by EIT. | Device | General anesthesia, Intensive Care Unit |
Primary outcome
Expiratory time constant
Time frame: 2 minutes after an intervention or a change in the ventilator settings
Time [in seconds], in which the lungs exhale 63% of the total volume.
Mechanical energy transferred to the lungs
Time frame: 2 minutes after an intervention or a change in the ventilator settings
Mechanical energy (alternatively referred to as mechanical work) [in Joules] is the energy delivered to the respiratory system during a single inspiration cycle.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Background: PubMed 30236123Karagiannidis 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.
- Background: PubMed 7774225Brunner 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.
- Background: PubMed 30204464Candik 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.
- Background: PubMed 27923979Henderson 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.
- Background: PubMed 22898553Vogt 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karel Roubík, prof. study director
Czech Technical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric impedance tomography in people with Mechanical Ventilation Complication and Ventilator-Induced Lung Injury, run by Czech Technical University in Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expiratory time constant (time frame: 2 minutes after an intervention or a change in the ventilator settings). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06236685, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.