Respiratory MechanicsNCT05946525
Ventilatory Variables in Subjects With Acute Respiratory Distress Syndrome Due to COVID-19
An observational study of Respiratory Mechanics and Respiration, Artificial, run by Hospital Donación Francisco Santojanni at 1 site in Argentina.
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? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Mechanics, Respiration, Artificial, Respiratory Distress Syndrome
- How many people
- 110 participants
- Where
- 1 siteArgentina
- Study dates
- 10 Feb 2023to 10 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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),
Who may be able to join
- Confirmed diagnosis of pneumonia due to COVID-19.
- Need of mechanical ventilation in intensive care unit.
Who cannot join
- Patients with data loses
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read the 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.
- Medical subject headings
- Respiratory Aspiration, Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
global mechanical power
0,098 × Tidal Volume × Respiratory Rate × (Peak Pressure - ½ Driving Pressure)
Measured: april 2020 to august 2021
Elastic Dynamic mechanical power
0,098 × Tidal Volume × Respiratory Rate × 0,5 × Driving Pressure
Measured: april 2020 to august 2021
Elastic static mechanical power
0,098 × Tidal Volume × Respiratory Rate × PEEP
Measured: april 2020 to august 2021
Resistive mechanical power
0,098 × Tidal Volume × Respiratory Rate × (Peak Pressure - Plateau Pressure)
Measured: april 2020 to august 2021
Ciclic Strain
Driving Pressure x 4 + Respiratory Rate
Measured: april 2020 to august 2021
Death
Death in intensive care unit
Measured: april 2020 to august 2021
Suvival
discharge alive from intensive care unit
Measured: april 2020 to august 2021
Secondary outcomes (2)
ventilatory rate
(Respiratory Rate x Tidal Volume x PCO2) / (Predicted body weight x 100 ml x 37.5)
Measured: april 2020 to august 2021
PaO2/FiO2
partial pressure O2 divided O2 fraction
Measured: april 2020 to august 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start10 Feb 2023
- Primary completion10 Feb 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory MechanicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Donación Francisco Santojanni
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Guillermo Bezzi, Hospital Donación Francisco Santojanni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946525
- Sponsor's protocol ID
- HS9258
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilatory Variables in Subjects With Acute Respiratory Distress Syndrome Due to COVID-19
- ClinicalTrials.gov ID
- NCT05946525
- Acronym / sponsor ID
- HS9258
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hospital Donación Francisco SantojanniUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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),
Key inclusion criteria (2 listed)
- Confirmed diagnosis of pneumonia due to COVID-19.
- Need of mechanical ventilation in intensive care unit.
Key exclusion criteria (1 listed)
- Patients with data loses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
global mechanical power
Time frame: april 2020 to august 2021
0,098 × Tidal Volume × Respiratory Rate × (Peak Pressure - ½ Driving Pressure)
Elastic Dynamic mechanical power
Time frame: april 2020 to august 2021
0,098 × Tidal Volume × Respiratory Rate × 0,5 × Driving Pressure
Elastic static mechanical power
Time frame: april 2020 to august 2021
0,098 × Tidal Volume × Respiratory Rate × PEEP
Resistive mechanical power
Time frame: april 2020 to august 2021
0,098 × Tidal Volume × Respiratory Rate × (Peak Pressure - Plateau Pressure)
Ciclic Strain
Time frame: april 2020 to august 2021
Driving Pressure x 4 + Respiratory Rate
Death
Time frame: april 2020 to august 2021
Death in intensive care unit
Suvival
Time frame: april 2020 to august 2021
discharge alive from intensive care unit
2 secondary outcomes
ventilatory rate
Time frame: april 2020 to august 2021
PaO2/FiO2
Time frame: april 2020 to august 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Mechanics and Respiration, Artificial, run by Hospital Donación Francisco Santojanni at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
global mechanical power (time frame: april 2020 to august 2021). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.