NCT04448782

Brief Summary

Prospective observational trial in patients admitted to ICU diagnosed with COVID-19 requiring invasive mechanical ventilation. Characterization of Reverse Triggering asynchrony during the first 5 days of invasive mechanical ventilation and other asynchronies, and its correlation with different outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

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

March 9, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 26, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

June 17, 2020

Last Update Submit

July 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence and pattern of presentation of Reverse triggering in COVID-19 patients under invasive mechanical ventilation

    To analyze the incidence of Reverse Triggering in the initial phases of invasive mechanical ventilation in COVID-19 patients

    during the 5 first days of invasive mechanical ventilation

Secondary Outcomes (4)

  • Incidence of Reverse Triggering related to the level of sedation in COVID-19 patients under invasive mechanical ventilation

    From the day of mechanical ventilation initation up to 5 days or the last day of mechanical ventilation

  • Reverse triggering and secondary asynchronies in COVID-19 patients under invasive mechanical ventilation

    From the day of mechanical ventilation initiation up to 5 days

  • Incidence and pattern of presentation of asynchronies in COVID-19 patients under invasive mechanical ventilation

    Each day from the day of mechanical ventilation initiation until the day of mechanical ventilation withdrawal or up to 28 days

  • Influence of asynchronies in different outcomes in in COVID-19 patients under invasive mechanical ventilation

    Each day from the day of mechanical ventilation initiation until the end of invasive mechanical ventilation, ICU discharge and hospital discharge or up to 28 days

Interventions

Asynchronies detectionDIAGNOSTIC_TEST

Asycnhronies detection

Eligibility Criteria

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

Adult patients admitted to the ICU under invasive mechanical ventilation with ARDS secondary to COVID-19

You may qualify if:

  • Patients under invasive mechanical ventilation more than 24 hours and with a minimum of 48 hours of respiratory signals registered from the ventilator
  • Diagnosis of COVID-19

You may not qualify if:

  • less than 48 hours of data,
  • age \< 18 years
  • admitted from other centers under invasive mechanical ventilation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Candelaria de Haro

Sabadell, Barcelona, 08208, Spain

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 26, 2020

Study Start

March 9, 2020

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations