Clinical trial NCT05679635: Evaluation of Tracheal Pressure During CPAP
Official title: Evaluation of Tracheal Pressure During Continuous Positive Airway Pressure Ventilation - a Prospective, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Continuous Positive Airway Pressure
CPAP Ventilation
Keywords: tracheal pressure
airway pressure
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, open, clinical trial
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: inspiratory tracheal pressure
timeFrame: 10 minutes after insertion of the tracheal pressure measurement catheter
Secondary outcomes:
measure: peak tracheal pressure
timeFrame: 10 minutes after insertion of the tracheal pressure measurement catheter
measure: mean tracheal pressure
timeFrame: 10 minutes after insertion of the tracheal pressure measurement catheter
measure: inspiratory tracheal pressure during automatic tube compensation (ATC)
timeFrame: 10 minutes after adding ATC
measure: inspiratory tracheal pressure during assisted spontaneous breathing (ASB)
timeFrame: 10 minutes after adding ASB
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
state: Tyrol
Study officials:
affiliation: Medical University of Innsbruck, Department of Anesthesiology and Intensive Care Medicine
name: Christopher Rugg, MD
role: PRINCIPAL_INVESTIGATOR
References: