NCT05494554

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2021

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 10, 2022

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

July 21, 2022

Last Update Submit

August 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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).

Device: Changing mechanical ventilation mode

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.

Device: Changing mechanical ventilation mode

Interventions

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.

Pressure control mode groupVolume control mode group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Furkan Tontu

    Intensivist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2022

First Posted

August 10, 2022

Study Start

January 1, 2020

Primary Completion

December 27, 2021

Study Completion

January 22, 2022

Last Updated

August 10, 2022

Record last verified: 2022-08

Locations