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Characterization of Reverse Triggering and Other Asynchronies in COVID-19 Patients Under Invasive Mechanical Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04448782
Recruitment Status : Completed
First Posted : June 26, 2020
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Candelaria de Haro, Corporacion Parc Tauli

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.

Condition or disease Intervention/treatment
Mechanical Ventilation Complication Diagnostic Test: Asynchronies detection

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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Reverse Triggering and Other Asynchronies in COVID-19 Patients Under Invasive Mechanical Ventilation
Actual Study Start Date : March 9, 2020
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Intervention Details:
  • Diagnostic Test: Asynchronies detection
    Asycnhronies detection


Primary Outcome Measures :
  1. Incidence and pattern of presentation of Reverse triggering in COVID-19 patients under invasive mechanical ventilation [ Time Frame: during the 5 first days of invasive mechanical ventilation ]
    To analyze the incidence of Reverse Triggering in the initial phases of invasive mechanical ventilation in COVID-19 patients


Secondary Outcome Measures :
  1. Incidence of Reverse Triggering related to the level of sedation in COVID-19 patients under invasive mechanical ventilation [ Time Frame: From the day of mechanical ventilation initation up to 5 days or the last day of mechanical ventilation ]
    To correlate the presence of Reverse Triggering with the level of sedation and use of neuromuscular blockers

  2. Reverse triggering and secondary asynchronies in COVID-19 patients under invasive mechanical ventilation [ Time Frame: From the day of mechanical ventilation initiation up to 5 days ]
    To analyze the incidence of breath stacking and ineffective efforts secondary to RT.

  3. Incidence and pattern of presentation of asynchronies in COVID-19 patients under invasive mechanical ventilation [ Time Frame: Each day from the day of mechanical ventilation initiation until the day of mechanical ventilation withdrawal or up to 28 days ]
    To analyze the incidence of RT, ineffective efforts and double triggering throughout the period of invasive mechanical ventilation

  4. Influence of asynchronies in different outcomes in in COVID-19 patients under invasive mechanical ventilation [ Time Frame: 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 ]
    To correlate the presence of asycnhronies and its type with duration of invasive mechanical ventilation, ICU length of stay and survival



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients admitted to the ICU under invasive mechanical ventilation with ARDS secondary to COVID-19
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04448782


Locations
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Spain
Candelaria de Haro
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli
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Responsible Party: Candelaria de Haro, Medical Doctor, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT04448782    
Other Study ID Numbers: RT COVID-19
First Posted: June 26, 2020    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No