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

Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05946525
• Other study ID #: HS9258
• Status: Completed
• Start date: February 10, 2023
• Est. completion date: February 10, 2023

Study information

• Verified date: July 2023
• Source: Hospital Donación Francisco Santojanni
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 10, 2023
• Est. primary completion date: February 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of pneumonia due to COVID-19.

• Need of mechanical ventilation in intensive care unit.

Exclusion Criteria:

• Patients with data loses

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiration, Artificial
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Mechanics
• Syndrome

Locations

Country	Name	City	State
Argentina	Hospital Santojanni	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Donación Francisco Santojanni

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	age	age in years	april 2020 to august 2021
Other	sex	male or female	april 2020 to august 2021
Other	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
Other	body mass index	body weight in kg divided squared heigh in m	april 2020 to august 2021
Primary	global mechanical power	0,098 × Tidal Volume × Respiratory Rate × (Peak Pressure - ½ Driving Pressure)	april 2020 to august 2021
Primary	Elastic Dynamic mechanical power	0,098 × Tidal Volume × Respiratory Rate × 0,5 × Driving Pressure	april 2020 to august 2021
Primary	Elastic static mechanical power	0,098 × Tidal Volume × Respiratory Rate × PEEP	april 2020 to august 2021
Primary	Resistive mechanical power	0,098 × Tidal Volume × Respiratory Rate × (Peak Pressure - Plateau Pressure)	april 2020 to august 2021
Primary	Ciclic Strain	Driving Pressure x 4 + Respiratory Rate	april 2020 to august 2021
Primary	Death	Death in intensive care unit	april 2020 to august 2021
Primary	Suvival	discharge alive from intensive care unit	april 2020 to august 2021
Secondary	ventilatory rate	(Respiratory Rate x Tidal Volume x PCO2) / (Predicted body weight x 100 ml x 37.5)	april 2020 to august 2021
Secondary	PaO2/FiO2	partial pressure O2 divided O2 fraction	april 2020 to august 2021