- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06413472
Comparing Mechanical Power in Different Inspiratory Times
July 25, 2025 updated by: Furkan Tontu, Başakşehir Çam & Sakura City Hospital
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- Basaksehir Cam Sakura City Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
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."
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with incomplete data.
- Patients diagnosed with:
- COPD (Chronic Obstructive Pulmonary Disease),
- Heart failure.
- Pregnant patients.
- Patients with a thoracopleural fistula.
- Hemodynamically unstable patients.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ARDS patients-PCV
Intubated patients with a diagnosis of ARDS in the intensive care unit, ventilated using Pressure-Controlled Ventilation (PCV).
|
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.
|
|
ARDS patients-VCV
Intubated patients with a diagnosis of ARDS in the intensive care unit, ventilated using Volume-Controlled Ventilation (VCV).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MPgeo
Time Frame: 40 minute
|
The mechanical power (MPgeo) values measured using the geometric method .
|
40 minute
|
|
Energy
Time Frame: 40 minute
|
Energy values measured using the geometric method .
|
40 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gattinoni 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.
- van 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.
- ARDS 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.
- Serpa 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.
- Giosa 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.
- Becher 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.
- 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.
- Asar 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.
- Chi 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.
- Asar 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.
- Acicbe 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2024
Primary Completion (Actual)
May 31, 2024
Study Completion (Actual)
June 1, 2024
Study Registration Dates
First Submitted
May 9, 2024
First Submitted That Met QC Criteria
May 13, 2024
First Posted (Actual)
May 14, 2024
Study Record Updates
Last Update Posted (Actual)
July 28, 2025
Last Update Submitted That Met QC Criteria
July 25, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-Tslope
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Not yet decided.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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