Evaluation of Tracheal Pressure During CPAP

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

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.

Study Overview

• Status: Completed
• Conditions: Continuous Positive Airway Pressure; CPAP Ventilation
• Intervention / Treatment: Device: Evone; Device: Evita Infinity V500

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Medical University of Innsbruck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Study participants; In intubated patients during CPAP ventilation, a conventional tube adapter (CTA, Ventinova Medical B.V., Eindhoven, The Netherlands) will be connected to the tracheal tube for tracheal pressure measurement. Tracheal pressure measurements will be recorded directly from the respirator Evone (Ventinova Medical B.V., Eindhoven, The Netherlands) three times, as well as the corresponding airway pressure values from the Evita Infinity V500 respirator (Dräger Medical, Lübeck, Germany). Study related time points: T1: 10 minutes after insertion of the conventional tube adapter during CPAP without ventilator support T2: 10 minutes after T1 during CPAP with activated automatic tube compensation (ATC) T3: 10 minutes after T2 during CPAP with assisted spontaneous breathing (ASB) of 4 cmH2O

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
peak tracheal pressure	The highest tracheal pressure value will be recorded	10 minutes after insertion of the tracheal pressure measurement catheter
mean tracheal pressure	The mean tracheal pressure value will be calculated	10 minutes after insertion of the tracheal pressure measurement catheter
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
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

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Christopher Rugg, MD, Medical University of Innsbruck, Department of Anesthesiology and Intensive Care Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2022
• Primary Completion (Actual): May 14, 2024
• Study Completion (Actual): May 14, 2024

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): January 11, 2023

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: tracheal pressure; airway pressure
• Other Study ID Numbers: 1224/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No