Skip to main content
Clinical Trials/NCT05679635
NCT05679635
Completed
Not Applicable

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

Medical University Innsbruck1 site in 1 country20 target enrollmentNovember 24, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Continuous Positive Airway Pressure
Sponsor
Medical University Innsbruck
Enrollment
20
Locations
1
Primary Endpoint
inspiratory tracheal pressure
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 24, 2022
End Date
May 14, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Medical University Innsbruck
Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

inspiratory tracheal pressure

Time Frame: 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 Outcomes

  • mean tracheal pressure(10 minutes after insertion of the tracheal pressure measurement catheter)
  • peak tracheal pressure(10 minutes after insertion of the tracheal pressure measurement catheter)
  • inspiratory tracheal pressure during automatic tube compensation (ATC)(10 minutes after adding ATC)
  • inspiratory tracheal pressure during assisted spontaneous breathing (ASB)(10 minutes after adding ASB)

Study Sites (1)

Loading locations...

Similar Trials