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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Respiratory Mechanics, Respiration, Artificial, Respiratory Distress Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of pneumonia due to COVID-19. Need of mechanical ventilation in intensive care unit. Exclusion Criteria: Patients with data loses

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global mechanical power | 0,098 × Tidal Volume × Respiratory Rate × (Peak Pressure - ½ Driving Pressure) | april 2020 to august 2021 | 
| Elastic Dynamic mechanical power | 0,098 × Tidal Volume × Respiratory Rate × 0,5 × Driving Pressure | april 2020 to august 2021 | 
| Elastic static mechanical power | 0,098 × Tidal Volume × Respiratory Rate × PEEP | april 2020 to august 2021 | 
| Resistive mechanical power | 0,098 × Tidal Volume × Respiratory Rate × (Peak Pressure - Plateau Pressure) | april 2020 to august 2021 | 
| Ciclic Strain | Driving Pressure x 4 + Respiratory Rate | april 2020 to august 2021 | 
| Death | Death in intensive care unit | april 2020 to august 2021 | 
| Suvival | discharge alive from intensive care unit | april 2020 to august 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilatory rate | (Respiratory Rate x Tidal Volume x PCO2) / (Predicted body weight x 100 ml x 37.5) | april 2020 to august 2021 | 
| PaO2/FiO2 | partial pressure O2 divided O2 fraction | april 2020 to august 2021 |