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

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05494554
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Actual Duration (Months): 24.7
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventilator-Induced Lung Injury	Device: Changing mechanical ventilation mode

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 Design

• Study Type: Observational
• Actual Enrollment: 36 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Comparison of Mechanical Power Calculations of Volume Control and Pressure Control Modes: A Prospective Observational Study
• Actual Study Start Date: Jan 1, 2020
• Actual Primary Completion Date: Dec 27, 2021
• Actual Study Completion Date: Jan 22, 2022

Arms and Interventions

Arm	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).	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.
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; 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.

Outcome Measures

Primary Outcome Measures

1. Mechanical power values of different ventilation modes [60 minutes]

   We aimed to compare the volume control and pressure control modes over the mechanical power values.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bakirkoy Dr. Sadi Konuk Research and Training Hospital	Istanbul		Turkey

Sponsors and Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

• Principal Investigator: Furkan Tontu, Intensivist

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• ClinicalTrials.gov Identifier: NCT05494554
• Other Study ID Numbers: 2019-02-23
• First Posted: Aug 10, 2022
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Injury; Ventilator-Induced Lung Injury

Study Results

No Results Posted as of Aug 10, 2022