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Completed

NCT Number: NCT05679635

Evaluation of Tracheal Pressure During CPAP

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Evone

Device

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

Device

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

Primary outcomes

  1. 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

  1. peak tracheal pressure

    Time frame: 10 minutes after insertion of the tracheal pressure measurement catheter

    The highest tracheal pressure value will be recorded

  2. mean tracheal pressure

    Time frame: 10 minutes after insertion of the tracheal pressure measurement catheter

    The mean tracheal pressure value will be calculated

  3. inspiratory tracheal pressure during automatic tube compensation (ATC)

    Time frame: 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.

  4. inspiratory tracheal pressure during assisted spontaneous breathing (ASB)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 11, 2023
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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