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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05679635
Other study ID # 1224/2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 24, 2022
Est. completion date May 14, 2024

Study information

Verified date May 2024
Source Medical University Innsbruck
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial evaluates tracheal pressure values in intubated intensive care unit patients during continuous positive airway pressure without any ventilatory support, automatic tube compensation and assisted spontaneous breathing.


Description:

Aim of this trial is to investigate if there are any significant differences between airway and tracheal pressure values during continuous positive airway pressure (CPAP) ventilation. For this purpose, a tracheal pressure measurement catheter is inserted into the tracheal tube and the obtained values are compared with the corresponding airway pressure measured on the ventilator. To further evaluate the impact of mild respiratory support automatic tube compensation and assisted spontaneous breathing with 4 cmH2O will be applied and measured pressure values compared as well. We hypothesize that tracheal pressure will be significantly lower than airway pressure values during inspiration, which represents the primary outcome measure. Secondary outcome parameters include comparison of expiratory and mean pressure values of airway and tracheal pressure. Additionally, effects of mild respiratory support will be evaluated as well. Measurement of inspiratory tracheal pressure might allow to calculate the pressure drop between the airway pressure at the Y-piece of the ventilator and the pressure at the trachea. Currently it is not known, if this pressure drop is significant during CPAP, which represents the rationale to perform this pilot study. In a second step it would be possible to determine if the recorded pressure drop can be used as a surrogate parameter for the respiratory drive in terms of a risk assessment for the development of patient self-inflected lung injury.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 14, 2024
Est. primary completion date May 14, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male and female subjects = 18 years - Intubated patient during CPAP without pressure support - Informed consent Exclusion Criteria: - Female subjects known to be pregnant - Known participation in another clinical trial - Critical pulmonary state (paO2/FiO2 ratio <100)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Evone
The conventional tube adapter (CTA) from the Evone ventilator (Ventinova Medical B.V., Eindhoven, The Netherlands), equipped with an tracheal pressure measurement catheter will be connected to the tracheal tube of intubated intensive care unit patients. Subsequently tracheal pressure values will be displayed and recorded from the ventilator.
Evita Infinity V500
Displayed airway pressure values will be directly recorded from the Evita Infinity V500 ventilator (Dräger Medical, Lübeck, Germany)

Locations

Country Name City State
Austria Medical University of Innsbruck Innsbruck Tyrol

Sponsors (1)

Lead Sponsor Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary inspiratory tracheal pressure The lowest tracheal pressure value, representing the highest inspiratory effort, will be recorded from the ventilator 10 minutes after insertion of the tracheal pressure measurement catheter
Secondary peak tracheal pressure The highest tracheal pressure value will be recorded 10 minutes after insertion of the tracheal pressure measurement catheter
Secondary mean tracheal pressure The mean tracheal pressure value will be calculated 10 minutes after insertion of the tracheal pressure measurement catheter
Secondary inspiratory tracheal pressure during automatic tube compensation (ATC) Effect of a mild respiratory support in terms of automatic tube compensation (ATC) on inspiratory tracheal pressure will be evaluated. 10 minutes after adding ATC
Secondary inspiratory tracheal pressure during assisted spontaneous breathing (ASB) Effect of a mild respiratory support in terms of assisted spontaneous breathing (ASB) with 4 cmH2O on inspiratory tracheal pressure will be evaluated. 10 minutes after adding ASB
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