Ventilatory Variables in Subjects With Acute Respiratory Distress Syndrome Due to COVID-19
Study Details
Study Description
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?
| Condition or Disease | Intervention/Treatment | Phase |
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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:
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Global mechanical power: 0.098 × Tidal Volume × Respiratory Rate × (Peak Pressure - ½ Distension Pressure)
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Dynamic elastic mechanical power: 0.098 × Tidal Volume × Respiratory Rate × 0.5 × Distension Pressure
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Static elastic mechanical power: 0.098 × Tidal Volume × Respiratory Rate × PEEP
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Resistive mechanical power: 0.098 × Tidal Volume × Respiratory Rate × (Peak Pressure - Plateau Pressure)
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Cyclic Strain: DP x 4 + Respiratory Rate.
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Driving Pressure adjusted to predicted body weight: Driving Pressure / Tidal Volume (in ml / kg of predicted weight).
Demographic Variables:
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Age: in years.
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Sex: female / male.
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ARDS Classification:
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Mild (PaO2 / FIO2 ≤ 300 mm Hg and > 200 mm Hg)
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Moderate (PaO2 / FIO2 ≤ 200 mm Hg and > 100 mm Hg)
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Severe (PaO2 / FIO2 ≤ 100 mm Hg)
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Body mass index: weight in kilograms divided by height in meters squared.
Gas Exchange Variables:
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Ventilatory quotient: (Respiratory Rate x Tidal Volume x PCO2) / (Predicted Weight x 100 ml x 37.5)
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Pa/FiO2: Arterial oxygen pressure/ Fraction of inspired oxygen Outcome Variables
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Mortality
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MV-free days at 28 days
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- global mechanical power [april 2020 to august 2021]
0,098 × Tidal Volume × Respiratory Rate × (Peak Pressure - ½ Driving Pressure)
- Elastic Dynamic mechanical power [april 2020 to august 2021]
0,098 × Tidal Volume × Respiratory Rate × 0,5 × Driving Pressure
- Elastic static mechanical power [april 2020 to august 2021]
0,098 × Tidal Volume × Respiratory Rate × PEEP
- Resistive mechanical power [april 2020 to august 2021]
0,098 × Tidal Volume × Respiratory Rate × (Peak Pressure - Plateau Pressure)
- Ciclic Strain [april 2020 to august 2021]
Driving Pressure x 4 + Respiratory Rate
- Death [april 2020 to august 2021]
Death in intensive care unit
- Suvival [april 2020 to august 2021]
discharge alive from intensive care unit
Secondary Outcome Measures
- ventilatory rate [april 2020 to august 2021]
(Respiratory Rate x Tidal Volume x PCO2) / (Predicted body weight x 100 ml x 37.5)
- PaO2/FiO2 [april 2020 to august 2021]
partial pressure O2 divided O2 fraction
Other Outcome Measures
- age [april 2020 to august 2021]
age in years
- sex [april 2020 to august 2021]
male or female
- acute respiratory distress syndrome grade [april 2020 to august 2021]
severe (PaO2/FiO2 < 100) Moderate (PaO2/FiO2 100 to 200) and mild (PaO2/FiO2 > 200 to 300)
- body mass index [april 2020 to august 2021]
body weight in kg divided squared heigh in m
Eligibility Criteria
Criteria
Inclusion Criteria:
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Confirmed diagnosis of pneumonia due to COVID-19.
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Need of mechanical ventilation in intensive care unit.
Exclusion Criteria:
- Patients with data loses
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Santojanni | Buenos Aires | Argentina |
Sponsors and Collaborators
- Hospital Donación Francisco Santojanni
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS9258