NCT05946525

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

Same day

First QC Date

July 10, 2023

Last Update Submit

July 13, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (2)

  • ventilatory rate

    april 2020 to august 2021

  • PaO2/FiO2

    april 2020 to august 2021

Other Outcomes (4)

  • age

    april 2020 to august 2021

  • sex

    april 2020 to august 2021

  • acute respiratory distress syndrome grade

    april 2020 to august 2021

  • +1 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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),

You may qualify if:

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

You may not qualify if:

  • Patients with data loses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Santojanni

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Respiratory AspirationRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Licenciado Kinesiólogo Fisiatra

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 14, 2023

Study Start

February 10, 2023

Primary Completion

February 10, 2023

Study Completion

February 10, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Locations