Evaluation of Tracheal Pressure During CPAP

Continuous Positive Airway Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05679635
• Other study ID #: 1224/2022
• Status: Recruiting
• Phase: N/A
• Start date: November 24, 2022
• Est. completion date: December 24, 2024

Study information

• Verified date: January 2024
• Source: Medical University Innsbruck
• Contact: Patrick Spraider, MD
• Phone: 0043 512 504 80329
• Email: patrick.spraider[@]i-med.ac.at
• Is FDA regulated: No
• 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: Recruiting
• Enrollment: 20
• Est. completion date: December 24, 2024
• Est. primary completion date: November 24, 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)

Related Conditions & MeSH terms

• Continuous Positive Airway Pressure
• CPAP Ventilation

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