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Clinical Trials/NCT05946525
NCT05946525
Completed
Not Applicable

Ventilatory Variables in Subjects With Acute Respiratory Distress Syndrome Due to COVID-19

Hospital Donación Francisco Santojanni1 site in 1 country110 target enrollmentFebruary 10, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Mechanics
Sponsor
Hospital Donación Francisco Santojanni
Enrollment
110
Locations
1
Primary Endpoint
Death
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Research question: Are the ventilatory variables related to mechanical power associated with the outcome of subjects who received mechanical ventilation (MV) for Acute Respiratory Distress Syndrome (ARDS) secondary to pneumonia (NMN) due to COVID-19?

Detailed Description

Primary Objective: - To evaluate the association between the ventilatory variables of mechanical power and the outcome of the subjects in terms of mortality, days on MV and days free of MV at 28 days (both in survivors). Secondary Objectives: - Evaluate the association of demographic and gas exchange variables with the outcome of the subjects. METHODOLOGY Study design: retrospective and observational, analytical. Operational definition of variables Ventilatory variables: * Global mechanical power: 0.098 × Tidal Volume × Respiratory Rate × (Peak Pressure - ½ Distension Pressure) * Dynamic elastic mechanical power: 0.098 × Tidal Volume × Respiratory Rate × 0.5 × Distension Pressure * Static elastic mechanical power: 0.098 × Tidal Volume × Respiratory Rate × PEEP * Resistive mechanical power: 0.098 × Tidal Volume × Respiratory Rate × (Peak Pressure - Plateau Pressure) * Cyclic Strain: DP x 4 + Respiratory Rate. * Driving Pressure adjusted to predicted body weight: Driving Pressure / Tidal Volume (in ml / kg of predicted weight). Demographic Variables: * Age: in years. * Sex: female / male. * ARDS Classification: * Mild (PaO2 / FIO2 ≤ 300 mm Hg and \> 200 mm Hg) * Moderate (PaO2 / FIO2 ≤ 200 mm Hg and \> 100 mm Hg) * Severe (PaO2 / FIO2 ≤ 100 mm Hg) * Body mass index: weight in kilograms divided by height in meters squared. Gas Exchange Variables: * Ventilatory quotient: (Respiratory Rate x Tidal Volume x PCO2) / (Predicted Weight x 100 ml x 37.5) * Pa/FiO2: Arterial oxygen pressure/ Fraction of inspired oxygen Outcome Variables * Mortality * MV-free days at 28 days * MV days Population and scope of study: Subjects registered in the ICU 2 database of the Francisco Santojanni Donation Hospital of the Autonomous City of Buenos Aires, who have received MV for ARDS with a confirmed diagnosis of COVID-19 pneumonia by polymerase chain reaction. Study period: Data from subjects admitted from April 2020 to August 2021 will be analyzed. Results analysis plan: A descriptive analysis of the clinical variables will be performed using the mean and standard deviation (SD), if the distribution is normal, or the median and interquartile range (IQR) otherwise. Categorical variables will be presented as absolute number of presentation and percentage. A value of p\<0.05 will be considered as statistically significant. SPSS software will be used for data analysis.

Registry
clinicaltrials.gov
Start Date
February 10, 2023
End Date
February 10, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital Donación Francisco Santojanni
Responsible Party
Principal Investigator
Principal Investigator

Marco Guillermo Bezzi

Licenciado Kinesiólogo Fisiatra

Hospital Donación Francisco Santojanni

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of pneumonia due to COVID-
  • Need of mechanical ventilation in intensive care unit.

Exclusion Criteria

  • Patients with data loses

Outcomes

Primary Outcomes

Death

Time Frame: april 2020 to august 2021

Death in intensive care unit

global mechanical power

Time Frame: april 2020 to august 2021

0,098 × Tidal Volume × Respiratory Rate × (Peak Pressure - ½ Driving Pressure)

Suvival

Time Frame: april 2020 to august 2021

discharge alive from intensive care unit

Resistive mechanical power

Time Frame: april 2020 to august 2021

0,098 × Tidal Volume × Respiratory Rate × (Peak Pressure - Plateau Pressure)

Ciclic Strain

Time Frame: april 2020 to august 2021

Driving Pressure x 4 + Respiratory Rate

Elastic Dynamic mechanical power

Time Frame: april 2020 to august 2021

0,098 × Tidal Volume × Respiratory Rate × 0,5 × Driving Pressure

Elastic static mechanical power

Time Frame: april 2020 to august 2021

0,098 × Tidal Volume × Respiratory Rate × PEEP

Secondary Outcomes

  • ventilatory rate(april 2020 to august 2021)
  • PaO2/FiO2(april 2020 to august 2021)

Study Sites (1)

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