Clinical trial NCT05946525: Ventilatory Variables in Subjects With Acute Respiratory Distress Syndrome Due to COVID-19
Official title: Ventilatory Variables in Subjects With Acute Respiratory Distress Syndrome Due to COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Mechanics
Respiration, Artificial
Respiratory Distress Syndrome
Lead sponsor: Hospital Donación Francisco Santojanni
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admited to the intensive care unit with Mechanical ventilation due to ARDS with confirmed diagnosis of COVID-19 pneumonia by polymerase chain reaction (PCR),

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients with data loses

Primary outcomes:
measure: global mechanical power
timeFrame: april 2020 to august 2021
measure: Elastic Dynamic mechanical power
timeFrame: april 2020 to august 2021
measure: Elastic static mechanical power
timeFrame: april 2020 to august 2021
measure: Resistive mechanical power
timeFrame: april 2020 to august 2021
measure: Ciclic Strain
timeFrame: april 2020 to august 2021
measure: Death
timeFrame: april 2020 to august 2021
measure: Suvival
timeFrame: april 2020 to august 2021
Secondary outcomes:
measure: ventilatory rate
timeFrame: april 2020 to august 2021
measure: PaO2/FiO2
timeFrame: april 2020 to august 2021
Other outcomes:
measure: age
timeFrame: april 2020 to august 2021
measure: sex
timeFrame: april 2020 to august 2021
measure: acute respiratory distress syndrome grade
timeFrame: april 2020 to august 2021
measure: body mass index
timeFrame: april 2020 to august 2021
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Santojanni
Study officials:
References: