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?

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome; Respiration, Artificial; Respiratory Mechanics

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.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Hospital Santojanni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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),

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with data loses

Study Plan

How is the study designed?

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
age	age in years	april 2020 to august 2021
sex	male or female	april 2020 to august 2021
acute respiratory distress syndrome grade	severe (PaO2/FiO2 < 100) Moderate (PaO2/FiO2 100 to 200) and mild (PaO2/FiO2 > 200 to 300)	april 2020 to august 2021
body mass index	body weight in kg divided squared heigh in m	april 2020 to august 2021

Collaborators and Investigators

• Sponsor: Hospital Donación Francisco Santojanni

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Actual): February 10, 2023
• Study Completion (Actual): February 10, 2023

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: HS9258

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No