Comparison of Mechanical Power Calculations of Volume Control and Pressure Control Modes

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

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

      • Istanbul, Turkey
        • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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).
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.
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.
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
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.
60 minutes

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

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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