Evaluation of Tracheal Pressure During CPAP

NCT05679635 | Completed DMC

• 1 other identifier: 1224/2022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Continuous Positive Airway Pressure; CPAP Ventilation

Keywords

tracheal pressure; airway pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• peak tracheal pressure

  10 minutes after insertion of the tracheal pressure measurement catheter

• mean 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 Arms (1)

Study participants

OTHER

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; Device: Evita Infinity V500

Interventions

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.

Study participants

Evita Infinity V500 DEVICE

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

Study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects ≥ 18 years
• Intubated patient during CPAP without pressure support
• Informed consent

You may not qualify if:

• Female subjects known to be pregnant
• Known participation in another clinical trial
• Critical pulmonary state (paO2/FiO2 ratio \<100)

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Study Officials

• Christopher Rugg, MD

  Medical University of Innsbruck, Department of Anesthesiology and Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, open, clinical trial

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: January 11, 2023
• Study Start: November 24, 2022
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)