Continuous Positive Airway Pressure, CPAP Ventilation
Conditions
Keywords
tracheal pressure, airway pressure
Brief 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.
Detailed 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.
Interventions
DEVICEEvone
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.
DEVICEEvita Infinity V500
Displayed airway pressure values will be directly recorded from the Evita Infinity V500 ventilator (Dräger Medical, Lübeck, Germany)
Sponsors
Medical University Innsbruck
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
prospective, open, clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| inspiratory tracheal pressure | 10 minutes after insertion of the tracheal pressure measurement catheter | The lowest tracheal pressure value, representing the highest inspiratory effort, will be recorded from the ventilator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mean tracheal pressure | 10 minutes after insertion of the tracheal pressure measurement catheter | The mean tracheal pressure value will be calculated |
| peak tracheal pressure | 10 minutes after insertion of the tracheal pressure measurement catheter | The highest tracheal pressure value will be recorded |
| inspiratory tracheal pressure during automatic tube compensation (ATC) | 10 minutes after adding ATC | Effect of a mild respiratory support in terms of automatic tube compensation (ATC) on inspiratory tracheal pressure will be evaluated. |
| inspiratory tracheal pressure during assisted spontaneous breathing (ASB) | 10 minutes after adding ASB | Effect of a mild respiratory support in terms of assisted spontaneous breathing (ASB) with 4 cmH2O on inspiratory tracheal pressure will be evaluated. |
Countries
Austria
Outcome results
None listed