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

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation Complication
• Intervention / Treatment: Diagnostic test: Asynchronies detection

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Candelaria De Haro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Reverse Triggering related to the level of sedation in COVID-19 patients under invasive mechanical ventilation	To correlate the presence of Reverse Triggering with the level of sedation and use of neuromuscular blockers	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	To analyze the incidence of breath stacking and ineffective efforts secondary to RT.	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	To analyze the incidence of RT, ineffective efforts and double triggering throughout the period of 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	To correlate the presence of asycnhronies and its type with duration of invasive mechanical ventilation, ICU length of stay and survival	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

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2020
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 26, 2020

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: RT COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No