Mechanical Ventilation Complication Clinical Trial
Official title:
Characterization of Reverse Triggering and Other Asynchronies in COVID-19 Patients Under Invasive Mechanical Ventilation
| NCT number | NCT04448782 |
| Other study ID # | RT COVID-19 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 9, 2020 |
| Est. completion date | June 30, 2020 |
| Verified date | July 2020 |
| Source | Corporacion Parc Tauli |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 32 |
| Est. completion date | June 30, 2020 |
| Est. primary completion date | June 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Candelaria de Haro | Sabadell | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Corporacion Parc Tauli |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |
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