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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05946525
Enrollment
110
Registered
2023-07-14
Start date
2023-02-10
Completion date
2023-02-10
Last updated
2023-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiration, Artificial, Respiratory Distress Syndrome, Respiratory Mechanics

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.

Interventions

None listed

Sponsors

Hospital Donación Francisco Santojanni
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Confirmed diagnosis of pneumonia due to COVID-19. * Need of mechanical ventilation in intensive care unit.

Exclusion criteria

* Patients with data loses

Design outcomes

Primary

MeasureTime frameDescription
Suvivalapril 2020 to august 2021discharge alive from intensive care unit
global mechanical powerapril 2020 to august 20210,098 × Tidal Volume × Respiratory Rate × (Peak Pressure - ½ Driving Pressure)
Elastic Dynamic mechanical powerapril 2020 to august 20210,098 × Tidal Volume × Respiratory Rate × 0,5 × Driving Pressure
Elastic static mechanical powerapril 2020 to august 20210,098 × Tidal Volume × Respiratory Rate × PEEP
Resistive mechanical powerapril 2020 to august 20210,098 × Tidal Volume × Respiratory Rate × (Peak Pressure - Plateau Pressure)
Ciclic Strainapril 2020 to august 2021Driving Pressure x 4 + Respiratory Rate
Deathapril 2020 to august 2021Death in intensive care unit

Secondary

MeasureTime frameDescription
PaO2/FiO2april 2020 to august 2021partial pressure O2 divided O2 fraction
ventilatory rateapril 2020 to august 2021(Respiratory Rate x Tidal Volume x PCO2) / (Predicted body weight x 100 ml x 37.5)

Other

MeasureTime frameDescription
body mass indexapril 2020 to august 2021body weight in kg divided squared heigh in m
ageapril 2020 to august 2021age in years
sexapril 2020 to august 2021male or female
acute respiratory distress syndrome gradeapril 2020 to august 2021severe (PaO2/FiO2 \< 100) Moderate (PaO2/FiO2 100 to 200) and mild (PaO2/FiO2 \> 200 to 300)

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026