Ventilator-Induced Lung InjuryNCT06413472
Comparing Mechanical Power in Different Inspiratory Times
An observational study of Ventilator-Induced Lung Injury and Acute Respiratory Distress Syndrome, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
We aimed to compare mechanical power and energy values using geometric methods at varying inspiratory rise times. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventilator-Induced Lung Injury, Acute Respiratory Distress Syndrome
- What is being tested?
- Mechanical ventilator adjustment for PCV and Mechanical ventilator adjustment for VCV
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Jun 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: "Patients with a diagnosis of ARDS in the general intensive care unit of the Anesthesiology and Reanimation Clinic at Bakırköy Dr. Sadi Konuk Training and Research Hospital."
Who may be able to join
- ARDS (Acute Respiratory Distress Syndrome) patients.
- Patients who are deeply sedated.
- Patients ventilated in:
- Pressure-Controlled Ventilation (PCV or PRVC) mode, or
- Volume-Controlled Ventilation (VCV) mode.
- Patients within the 24-48 hour period of their stay in the intensive care unit.
Who cannot join
- Patients with incomplete data.
- Patients diagnosed with:
- COPD (Chronic Obstructive Pulmonary Disease),
- Heart failure.
- Pregnant patients.
- Patients with a thoracopleural fistula.
- Hemodynamically unstable patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Mechanical Power Values Using Geometric Methods at Different Inspiratory Rise and Pause Times: A Validation Study
We aimed to compare mechanical power and energy values using geometric methods at varying inspiratory rise times.
Read the detailed description
In this study, the researchers aim to compare the mechanical power and energy values calculated using the geometric method in Volume-Controlled Ventilation (VCV) and Pressure-Controlled Ventilation (PCV) modes at different inspiratory rise times.
- Being tested
- Mechanical ventilator adjustment for PCV, Mechanical ventilator adjustment for VCV
- Medical subject headings
- Ventilator-Induced Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilator adjustment for PCVProcedure or surgery
In pressure control ventilation (PCV) mode, patients will be ventilated for 5 minutes at a Tslope of 5% and another 5 minutes at 15% for both 1:1 and 1:2 I:E ratios. After each adjustment, screenshots of the mechanical ventilator (P-V loop screenshots) will be obtained . A total of 20 P-V loop screenshots will be captured over a 20-minute period (10 for the 1:2 ratio and 10 for the 1:1 ratio), which will be stored in the ventilators memory. The stored data will then be transferred from the ventilators memory to a computer via a flash drive.
Mechanical ventilator adjustment for VCVProcedure or surgery
In volume control ventilation (VCV) mode, patients will be ventilated for 5 minutes at a Tslope of 5% and another 5 minutes at 15% for both 1:1 and 1:2 I:E ratios. After each adjustment, screenshots of the mechanical ventilator (P-V loop screenshots) will be obtained . A total of 20 P-V loop screenshots will be captured over a 20-minute period (10 for the 1:2 ratio and 10 for the 1:1 ratio), which will be stored in the ventilators memory. The stored data will then be transferred from the ventilators memory to a computer via a flash drive.
| Study group | Role | What they receive |
|---|---|---|
| ARDS patients-PCV | Intubated patients with a diagnosis of ARDS in the intensive care unit, ventilated using Pressure-Controlled Ventilation (PCV). Receives: Procedure: Mechanical ventilator adjustment for PCV | |
| ARDS patients-VCV | Intubated patients with a diagnosis of ARDS in the intensive care unit, ventilated using Volume-Controlled Ventilation (VCV). Receives: Procedure: Mechanical ventilator adjustment for VCV |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPgeo
The mechanical power (MPgeo) values measured using the geometric method .
Measured: 40 minute
Energy
Energy values measured using the geometric method .
Measured: 40 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start1 Mar 2024
- Primary completion31 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Collaborators
- SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
- Responsible party
- Principal investigator, Furkan Tontu, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413472
- Sponsor's protocol ID
- 2024-Tslope
- Status last verified
- Jul 2025
- First submitted
- 9 May 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet decided.
Publications
Trinkle CA, Broaddus RN, Sturgill JL, Waters CM, Morris PE. Simple, accurate calculation of mechanical power in pressure controlled ventilation (PCV). Intensive Care Med Exp. 2022 May 30;10(1):22. doi: 10.1186/s40635-022-00448-5.
PubMed 35644896Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
PubMed 27620287Serpa Neto A, Deliberato RO, Johnson AEW, Bos LD, Amorim P, Pereira SM, Cazati DC, Cordioli RL, Correa TD, Pollard TJ, Schettino GPP, Timenetsky KT, Celi LA, Pelosi P, Gama de Abreu M, Schultz MJ; PROVE Network Investigators. Mechanical power of ventilation is associated with mortality in critically ill patients: an analysis of patients in two observational cohorts. Intensive Care Med. 2018 Nov;44(11):1914-1922. doi: 10.1007/s00134-018-5375-6. Epub 2018 Oct 5.
PubMed 30291378Asar S, Acicbe O, Cukurova Z, Hergunsel GO, Canan E, Cakar N. Bedside dynamic calculation of mechanical power: A validation study. J Crit Care. 2020 Apr;56:167-170. doi: 10.1016/j.jcrc.2019.12.027. Epub 2020 Jan 2.
PubMed 31931417Giosa L, Busana M, Pasticci I, Bonifazi M, Macri MM, Romitti F, Vassalli F, Chiumello D, Quintel M, Marini JJ, Gattinoni L. Mechanical power at a glance: a simple surrogate for volume-controlled ventilation. Intensive Care Med Exp. 2019 Nov 27;7(1):61. doi: 10.1186/s40635-019-0276-8.
PubMed 31773328Chi Y, He H, Long Y. A simple method of mechanical power calculation: using mean airway pressure to replace plateau pressure. J Clin Monit Comput. 2021 Oct;35(5):1139-1147. doi: 10.1007/s10877-020-00575-y. Epub 2020 Aug 11.
PubMed 32780353Becher T, van der Staay M, Schadler D, Frerichs I, Weiler N. Calculation of mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Sep;45(9):1321-1323. doi: 10.1007/s00134-019-05636-8. Epub 2019 May 17. No abstract available.
PubMed 31101961van der Meijden S, Molenaar M, Somhorst P, Schoe A. Calculating mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Oct;45(10):1495-1497. doi: 10.1007/s00134-019-05698-8. Epub 2019 Jul 29. No abstract available.
PubMed 31359082Asar S, Acicbe O, Sabaz MS, Kucur Tulubas E, Hergunsel GO, Cukurova Z, Canan E, Cakar N. Simplified calculation of mechanical power for pressure controlled ventilation in Covid-19 ARDS patients. Minerva Anestesiol. 2022 Jan-Feb;88(1-2):42-50. doi: 10.23736/S0375-9393.21.15741-4.
PubMed 35224956Acicbe O, Ozgur CY, Rahimi P, Canan E, Asar S, Cukurova Z. The effect of inspiratory rise time on mechanical power calculations in pressure control ventilation: dynamic approach. Intensive Care Med Exp. 2023 Dec 20;11(1):98. doi: 10.1186/s40635-023-00584-6.
PubMed 38117345ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
PubMed 22797452
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Mechanical Power Values Using Geometric Methods at Different Inspiratory Rise and Pause Times: A Validation Study
- ClinicalTrials.gov ID
- NCT06413472
- Acronym / sponsor ID
- 2024-Tslope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Collaborators
- SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 14 May 2024 (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.
We aimed to compare mechanical power and energy values using geometric methods at varying inspiratory rise times.
Detailed description
In this study, the researchers aim to compare the mechanical power and energy values calculated using the geometric method in Volume-Controlled Ventilation (VCV) and Pressure-Controlled Ventilation (PCV) modes at different inspiratory rise times.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARDS patients-PCV | – | Procedure: Mechanical ventilator adjustment for PCVIntubated patients with a diagnosis of ARDS in the intensive care unit, ventilated using Pressure-Controlled Ventilation (PCV). |
| ARDS patients-VCV | – | Procedure: Mechanical ventilator adjustment for VCVIntubated patients with a diagnosis of ARDS in the intensive care unit, ventilated using Volume-Controlled Ventilation (VCV). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- "Patients with a diagnosis of ARDS in the general intensive care unit of the Anesthesiology and Reanimation Clinic at Bakırköy Dr. Sadi Konuk Training and Research Hospital."
Key inclusion criteria (6 listed)
- ARDS (Acute Respiratory Distress Syndrome) patients.
- Patients who are deeply sedated.
- Patients ventilated in:
- Pressure-Controlled Ventilation (PCV or PRVC) mode, or
- Volume-Controlled Ventilation (VCV) mode.
Key exclusion criteria (7 listed)
- Patients with incomplete data.
- Patients diagnosed with:
- COPD (Chronic Obstructive Pulmonary Disease),
- Heart failure.
- Pregnant patients.
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 |
|---|---|---|
| Mechanical ventilator adjustment for PCVIn pressure control ventilation (PCV) mode, patients will be ventilated for 5 minutes at a Tslope of 5% and another 5 minutes at 15% for both 1:1 and 1:2 I:E ratios. After each adjustment, screenshots of the mechanical ventilator (P-V loop screenshots) will be obtained . A total of 20 P-V loop screenshots will be captured over a 20-minute period (10 for the 1:2 ratio and 10 for the 1:1 ratio), which will be stored in the ventilators memory. The stored data will then be transferred from the ventilators memory to a computer via a flash drive. | Procedure or surgery | ARDS patients-PCV |
| Mechanical ventilator adjustment for VCVIn volume control ventilation (VCV) mode, patients will be ventilated for 5 minutes at a Tslope of 5% and another 5 minutes at 15% for both 1:1 and 1:2 I:E ratios. After each adjustment, screenshots of the mechanical ventilator (P-V loop screenshots) will be obtained . A total of 20 P-V loop screenshots will be captured over a 20-minute period (10 for the 1:2 ratio and 10 for the 1:1 ratio), which will be stored in the ventilators memory. The stored data will then be transferred from the ventilators memory to a computer via a flash drive. | Procedure or surgery | ARDS patients-VCV |
Primary outcome
MPgeo
Time frame: 40 minute
The mechanical power (MPgeo) values measured using the geometric method .
Energy
Time frame: 40 minute
Energy values measured using the geometric method .
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 Jul 2025.
- Results publication: PubMed 35644896Trinkle CA, Broaddus RN, Sturgill JL, Waters CM, Morris PE. Simple, accurate calculation of mechanical power in pressure controlled ventilation (PCV). Intensive Care Med Exp. 2022 May 30;10(1):22. doi: 10.1186/s40635-022-00448-5.
- Results publication: PubMed 27620287Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
- Results publication: PubMed 30291378Serpa Neto A, Deliberato RO, Johnson AEW, Bos LD, Amorim P, Pereira SM, Cazati DC, Cordioli RL, Correa TD, Pollard TJ, Schettino GPP, Timenetsky KT, Celi LA, Pelosi P, Gama de Abreu M, Schultz MJ; PROVE Network Investigators. Mechanical power of ventilation is associated with mortality in critically ill patients: an analysis of patients in two observational cohorts. Intensive Care Med. 2018 Nov;44(11):1914-1922. doi: 10.1007/s00134-018-5375-6. Epub 2018 Oct 5.
- Results publication: PubMed 31931417Asar S, Acicbe O, Cukurova Z, Hergunsel GO, Canan E, Cakar N. Bedside dynamic calculation of mechanical power: A validation study. J Crit Care. 2020 Apr;56:167-170. doi: 10.1016/j.jcrc.2019.12.027. Epub 2020 Jan 2.
- Results publication: PubMed 31773328Giosa L, Busana M, Pasticci I, Bonifazi M, Macri MM, Romitti F, Vassalli F, Chiumello D, Quintel M, Marini JJ, Gattinoni L. Mechanical power at a glance: a simple surrogate for volume-controlled ventilation. Intensive Care Med Exp. 2019 Nov 27;7(1):61. doi: 10.1186/s40635-019-0276-8.
- Results publication: PubMed 32780353Chi Y, He H, Long Y. A simple method of mechanical power calculation: using mean airway pressure to replace plateau pressure. J Clin Monit Comput. 2021 Oct;35(5):1139-1147. doi: 10.1007/s10877-020-00575-y. Epub 2020 Aug 11.
- Results publication: PubMed 31101961Becher T, van der Staay M, Schadler D, Frerichs I, Weiler N. Calculation of mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Sep;45(9):1321-1323. doi: 10.1007/s00134-019-05636-8. Epub 2019 May 17. No abstract available.
- Results publication: PubMed 31359082van der Meijden S, Molenaar M, Somhorst P, Schoe A. Calculating mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Oct;45(10):1495-1497. doi: 10.1007/s00134-019-05698-8. Epub 2019 Jul 29. No abstract available.
- Results publication: PubMed 35224956Asar S, Acicbe O, Sabaz MS, Kucur Tulubas E, Hergunsel GO, Cukurova Z, Canan E, Cakar N. Simplified calculation of mechanical power for pressure controlled ventilation in Covid-19 ARDS patients. Minerva Anestesiol. 2022 Jan-Feb;88(1-2):42-50. doi: 10.23736/S0375-9393.21.15741-4.
- Results publication: PubMed 38117345Acicbe O, Ozgur CY, Rahimi P, Canan E, Asar S, Cukurova Z. The effect of inspiratory rise time on mechanical power calculations in pressure control ventilation: dynamic approach. Intensive Care Med Exp. 2023 Dec 20;11(1):98. doi: 10.1186/s40635-023-00584-6.
- Results publication: PubMed 22797452ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
- Individual participant dataSharing planned: Undecided. Not yet decided.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Acute Respiratory Distress Syndrome, run by Başakşehir Çam & Sakura City 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 6 inclusion and 7 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 Jul 2025. 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?
MPgeo (time frame: 40 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06413472, which also lists 11 linked publications.
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 Jul 2025.