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Completed

NCT Number: NCT05946525

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

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Santojanni

Buenos Aires, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with data loses

Treatment and study plan

Primary outcomes

  1. global mechanical power

    Time frame: april 2020 to august 2021

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

  2. Elastic Dynamic mechanical power

    Time frame: april 2020 to august 2021

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

  3. Elastic static mechanical power

    Time frame: april 2020 to august 2021

    0,098 × Tidal Volume × Respiratory Rate × PEEP

  4. Resistive mechanical power

    Time frame: april 2020 to august 2021

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

  5. Ciclic Strain

    Time frame: april 2020 to august 2021

    Driving Pressure x 4 + Respiratory Rate

  6. Death

    Time frame: april 2020 to august 2021

    Death in intensive care unit

  7. Suvival

    Time frame: april 2020 to august 2021

    discharge alive from intensive care unit

Secondary outcomes

  1. ventilatory rate

    Time frame: april 2020 to august 2021

    (Respiratory Rate x Tidal Volume x PCO2) / (Predicted body weight x 100 ml x 37.5)

  2. PaO2/FiO2

    Time frame: april 2020 to august 2021

    partial pressure O2 divided O2 fraction

Other outcomes

  1. age

    Time frame: april 2020 to august 2021

    age in years

  2. sex

    Time frame: april 2020 to august 2021

    male or female

  3. acute respiratory distress syndrome grade

    Time frame: april 2020 to august 2021

    severe (PaO2/FiO2 < 100) Moderate (PaO2/FiO2 100 to 200) and mild (PaO2/FiO2 > 200 to 300)

  4. body mass index

    Time frame: april 2020 to august 2021

    body weight in kg divided squared heigh in m

Sponsors and collaborators

Lead sponsor

Hospital Donación Francisco Santojanni

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 14, 2023
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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