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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05494554
Other study ID # 2019-02-23
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date January 22, 2022

Study information

Verified date August 2022
Source Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date January 22, 2022
Est. primary completion date December 27, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Changing mechanical ventilation mode
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.

Locations

Country Name City State
Turkey Bakirkoy Dr. Sadi Konuk Research and Training Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mechanical power values of different ventilation modes We aimed to compare the volume control and pressure control modes over the mechanical power values. 60 minutes
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