NCT05679635

Evaluation of Tracheal Pressure During CPAP

Evaluation of Tracheal Pressure During Continuous Positive Airway Pressure Ventilation - a Prospective, Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Continuous Positive Airway Pressure
• CPAP Ventilation

Interventions

Type	Name	Description
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.
DEVICE	Evita Infinity V500	Displayed airway pressure values will be directly recorded from the Evita Infinity V500 ventilator (Dräger Medical, Lübeck, Germany)

Timeline

• Start date: 2022-11-24
• Primary completion: 2024-05-14
• Completion: 2024-05-14
• First posted: 2023-01-11
• Last updated: 2024-05-28

Locations

1 site across 1 country: Austria