Ventilator-Induced Lung InjuryNCT05494554
Comparison of Mechanical Power Calculations of Volume Control and Pressure Control Modes
An observational study of Ventilator-Induced Lung Injury, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The management of ARDS, which is one of the important problems of intensive care patients, has gained popularity with the pandemic. Mechanical ventilation is an important life-saving treatment in ARDS patients. However, when not used correctly, it can cause Ventilator-Induced Lung Injury (VILI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-Induced Lung Injury
- What is being tested?
- Changing mechanical ventilation mode
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 22 Jan 2022
- Phase
- Observational
- 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
Study population: This study was conducted prospectively with 36 Covid-19 ARDS patients who were followed up in the Dr. Sadi Konuk Training and Research Hospital Anesthesia and Intensive Care Unit and diagnosed with ARDS according to the Berlin criteria. The definite COVID-19 diagnosis was confirmed by PCR (Bio-Speedy Covid-19 RT-Qpcr detection Kit-Bioeksen, Turkey) obtained from the nasal swab sample and chest computed tomography images.
Who may be able to join
- Patients with confirmed Covid-19 diagnosis in intensive care unit (ICU) and diagnosed with ARDS according to Berlin criteria
- Intubated patients which treated in the supine position on the second day of ICU admission
Who cannot join
- Patients with a known diagnosis of COPD
- Patients experiencing hemodynamic instability during ventilation
- Prone pozisyonda olan hastalar
- Patients receiving inotropic support
- Patients with missing data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul
About this study
Official title: Comparison of Mechanical Power Calculations of Volume Control and Pressure Control Modes: A Prospective Observational Study
The management of ARDS, which is one of the important problems of intensive care patients, has gained popularity with the pandemic. Mechanical ventilation is an important life-saving treatment in ARDS patients. However, when not used correctly, it can cause Ventilator-Induced Lung Injury (VILI). Therefore, lung protective ventilation should be applied to minimize VILI in ARDS patients. Mechanical power is one of the parameters that guides intensivist in predicting VILI.
Read the detailed description
The goal of mechanical ventilation in ARDS patients is to improve oxygenation by reducing the work of breathing . With this aim, the orientation towards sensitive ventilation strategies has increased in the light of experience and scientific data from the past to the present. Today, the concept of Mechanical Power (MP) has been developed, which combines different variables, such as tidal volume, drive pressure, gas flow, respiratory rate, and PEEP, which have been associated with VILI in various studies, into a single parameter. In this study, the investigators used the simplified MP equation (MPvcv (simpl)) developed by Gattinoni et al. for power calculation in volume control mode and the simplified MP equation (MPpcv(simpl)) developed by Becher et al. for power calculation in pressure control mode. Thus, the investigators aimed to compare the volume control and pressure control modes over the concept of MP.
- Conditions
- Ventilator-Induced Lung Injury
- Being tested
- Changing mechanical ventilation mode
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changing mechanical ventilation modeDevice
On the 2nd day of intensive care hospitalization, while under deep sedation and in the controlled mode (VCV or PRVC) and in the supine position, the ventilator in the VCV mode was switched to PRVC mode for 60 minutes without changing any of the set ventilator settings (RR, PEEP, TV, I:E ratio). Likewise, if it is in PRVC mode, it is also switched to VCV mode for 60 minutes. MP values were calculated from the minute respiratory parameters of all patients with the MP formulas defined in the software.
| Study group | Role | What they receive |
|---|---|---|
| Pressure control mode group | On the 2nd day of intensive care hospitalization, while under deep sedation and in the controlled mode (VCV or PRVC) and in the supine position, the ventilator in the VCV mode was switched to PRVC mode for 60 minutes without changing any of the set ventilator settings (RR, PEEP, TV, I:E ratio). Receives: Device: Changing mechanical ventilation mode | |
| Volume control mode group | Likewise, if it is in PRVC mode, it is also switched to VCV mode for 60 minutes. In this way, two dependent groups were formed. Receives: Device: Changing mechanical ventilation mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical power values of different ventilation modes
We aimed to compare the volume control and pressure control modes over the mechanical power values.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Jan 2020
- Primary completion27 Dec 2021
- Study completion22 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Induced Lung InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Furkan Tontu, Principal investigator, Intensivist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494554
- Sponsor's protocol ID
- 2019-02-23
- Status last verified
- Aug 2022
- First submitted
- 21 Jul 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mechanical Power Calculations of Volume Control and Pressure Control Modes: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05494554
- Acronym / sponsor ID
- 2019-02-23
- Conditions
- Ventilator-Induced Lung Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 27 Dec 2021 (actual)
- Study completion
- 22 Jan 2022 (actual)
- First posted
- 10 Aug 2022 (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.
The management of ARDS, which is one of the important problems of intensive care patients, has gained popularity with the pandemic. Mechanical ventilation is an important life-saving treatment in ARDS patients. However, when not used correctly, it can cause Ventilator-Induced Lung Injury (VILI). Therefore, lung protective ventilation should be applied to minimize VILI in ARDS patients. Mechanical power is one of the parameters that guides intensivist in predicting VILI.
Detailed description
The goal of mechanical ventilation in ARDS patients is to improve oxygenation by reducing the work of breathing . With this aim, the orientation towards sensitive ventilation strategies has increased in the light of experience and scientific data from the past to the present. Today, the concept of Mechanical Power (MP) has been developed, which combines different variables, such as tidal volume, drive pressure, gas flow, respiratory rate, and PEEP, which have been associated with VILI in various studies, into a single parameter. In this study, the investigators used the simplified MP equation (MPvcv (simpl)) developed by Gattinoni et al. for power calculation in volume control mode and the simplified MP equation (MPpcv(simpl)) developed by Becher et al. for power calculation in pressure control mode. Thus, the investigators aimed to compare the volume control and pressure control modes over the concept of MP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure control mode group | – | Device: Changing mechanical ventilation modeOn the 2nd day of intensive care hospitalization, while under deep sedation and in the controlled mode (VCV or PRVC) and in the supine position, the ventilator in the VCV mode was switched to PRVC mode for 60 minutes without changing any of the set ventilator settings (RR, PEEP, TV, I:E ratio). |
| Volume control mode group | – | Device: Changing mechanical ventilation modeLikewise, if it is in PRVC mode, it is also switched to VCV mode for 60 minutes. In this way, two dependent groups were formed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study was conducted prospectively with 36 Covid-19 ARDS patients who were followed up in the Dr. Sadi Konuk Training and Research Hospital Anesthesia and Intensive Care Unit and diagnosed with ARDS according to the Berlin criteria. The definite COVID-19 diagnosis was confirmed by PCR (Bio-Speedy Covid-19 RT-Qpcr detection Kit-Bioeksen, Turkey) obtained from the nasal swab sample and chest computed tomography images.
Key inclusion criteria (2 listed)
- Patients with confirmed Covid-19 diagnosis in intensive care unit (ICU) and diagnosed with ARDS according to Berlin criteria
- Intubated patients which treated in the supine position on the second day of ICU admission
Key exclusion criteria (5 listed)
- Patients with a known diagnosis of COPD
- Patients experiencing hemodynamic instability during ventilation
- Prone pozisyonda olan hastalar
- Patients receiving inotropic support
- Patients with missing data
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 |
|---|---|---|
| Changing mechanical ventilation modeOn the 2nd day of intensive care hospitalization, while under deep sedation and in the controlled mode (VCV or PRVC) and in the supine position, the ventilator in the VCV mode was switched to PRVC mode for 60 minutes without changing any of the set ventilator settings (RR, PEEP, TV, I:E ratio). Likewise, if it is in PRVC mode, it is also switched to VCV mode for 60 minutes. MP values were calculated from the minute respiratory parameters of all patients with the MP formulas defined in the software. | Device | Pressure control mode group, Volume control mode group |
Primary outcome
Mechanical power values of different ventilation modes
Time frame: 60 minutes
We aimed to compare the volume control and pressure control modes over the mechanical power values.
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 10 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
Furkan Tontu principal investigator
Intensivist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator-Induced Lung Injury, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 10 Aug 2022. 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 Turkey (Türkiye). 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?
Mechanical power values of different ventilation modes (time frame: 60 minutes). 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 10 Aug 2022.