Continuous Positive Airway PressureNCT05679635
Evaluation of Tracheal Pressure During CPAP
A study testing Evone and Evita Infinity V500 in people with Continuous Positive Airway Pressure and CPAP Ventilation, run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous Positive Airway Pressure, CPAP Ventilation
- What is being tested?
- Evone and Evita Infinity V500
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 24 Nov 2022to 14 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects ≥ 18 years
- Intubated patient during CPAP without pressure support
- Informed consent
Who cannot join
- Female subjects known to be pregnant
- Known participation in another clinical trial
- Critical pulmonary state (paO2/FiO2 ratio <100)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Evone, Evita Infinity V500
- Keywords
- tracheal pressure, airway pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvoneDevice
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 V500Device
Displayed airway pressure values will be directly recorded from the Evita Infinity V500 ventilator (Dräger Medical, Lübeck, Germany)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Evone; Device: Evita Infinity V500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
inspiratory tracheal pressure
The lowest tracheal pressure value, representing the highest inspiratory effort, will be recorded from the ventilator
Measured: 10 minutes after insertion of the tracheal pressure measurement catheter
Secondary outcomes (4)
peak tracheal pressure
The highest tracheal pressure value will be recorded
Measured: 10 minutes after insertion of the tracheal pressure measurement catheter
mean tracheal pressure
The mean tracheal pressure value will be calculated
Measured: 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.
Measured: 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.
Measured: 10 minutes after adding ASB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start24 Nov 2022
- Primary completion14 May 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Positive Airway PressureStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, open, clinical trial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Rugg, MD, Principal investigator, Medical University of Innsbruck, Department of Anesthesiology and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679635
- Sponsor's protocol ID
- 1224/2022
- Status last verified
- May 2024
- First submitted
- 28 Nov 2022
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tracheal Pressure During Continuous Positive Airway Pressure Ventilation - a Prospective, Clinical Trial
- ClinicalTrials.gov ID
- NCT05679635
- Acronym / sponsor ID
- 1224/2022
- Keywords
- tracheal pressure, airway pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, open, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Study participants | Other | Device: Evone, Device: Evita Infinity V500In 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects ≥ 18 years
- Intubated patient during CPAP without pressure support
- Informed consent
Key exclusion criteria (3 listed)
- Female subjects known to be pregnant
- Known participation in another clinical trial
- Critical pulmonary state (paO2/FiO2 ratio <100)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvoneThe 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 | Study participants |
| Evita Infinity V500Displayed airway pressure values will be directly recorded from the Evita Infinity V500 ventilator (Dräger Medical, Lübeck, Germany) | Device | Study participants |
Primary outcome
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
4 secondary outcomes
peak tracheal pressure
Time frame: 10 minutes after insertion of the tracheal pressure measurement catheter
mean tracheal pressure
Time frame: 10 minutes after insertion of the tracheal pressure measurement catheter
inspiratory tracheal pressure during automatic tube compensation (ATC)
Time frame: 10 minutes after adding ATC
inspiratory tracheal pressure during assisted spontaneous breathing (ASB)
Time frame: 10 minutes after adding ASB
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: No
Related trials for Continuous Positive Airway Pressure
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingPhase 2/3
Tirzepatide Versus Positive Airway Pressure for the Treatment of Obstructive Sleep Apnoea
Sleep Apnoea, Obesity & Overweight
Not yet recruiting
Comparing Two Types of Breathing Support in People With COPD, High Carbon Dioxide Levels, and Sleep Apnea
OSA COPD Overlap Syndrome
Not yet recruiting
Dexametedomidine Ketamine Infusion Versus Dexametedomidine Propofol Infusion in Non-compliant Agitated Patients on Continuous Positive Airway Pressure (CPAP) Mask Ventilation in the Intensive Care Unit
CPAP Ventilation, Sedation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Rugg, MD principal investigator
Medical University of Innsbruck, Department of Anesthesiology and Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evone and Evita Infinity V500 in people with Continuous Positive Airway Pressure and CPAP Ventilation, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inspiratory tracheal pressure (time frame: 10 minutes after insertion of the tracheal pressure measurement catheter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.