- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05494554
Comparison of Mechanical Power Calculations of Volume Control and Pressure Control Modes
August 9, 2022 updated by: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
36
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
- Bakirkoy Dr. Sadi Konuk Research and Training 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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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 |
|---|---|
|
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).
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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.
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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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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60 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Furkan Tontu, Intensivist
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)
January 1, 2020
Primary Completion (Actual)
December 27, 2021
Study Completion (Actual)
January 22, 2022
Study Registration Dates
First Submitted
July 21, 2022
First Submitted That Met QC Criteria
August 9, 2022
First Posted (Actual)
August 10, 2022
Study Record Updates
Last Update Posted (Actual)
August 10, 2022
Last Update Submitted That Met QC Criteria
August 9, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-02-23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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