Risk Factors for Prolonged Invasive Mechanical Ventilation in COVID-19 Acute Respiratory Distress Syndrome
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|ClinicalTrials.gov Identifier: NCT04411459|
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : July 28, 2020
|Condition or disease||Intervention/treatment|
|COVID-19 Mechanical Ventilation Quality of Life Radiologic Increased Density of Lung Sedation Complication of Treatment||Other: Invasive mechanical ventilation|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||Risk Factors for Prolonged Invasive Mechanical Ventilation in COVID-19 Acute Respiratory Distress Syndrome|
|Actual Study Start Date :||February 1, 2020|
|Actual Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||October 30, 2020|
COVID-19 pneumonia patients
Patients needing intubation and mechanical ventilation for COVID-19 related pneumonia without other primary causes of ICU admission
Other: Invasive mechanical ventilation
Invasive mechanical ventilation for respiratory failure associated to COVID-19 pneumonia
- Duration of mechanical ventilation and 28 days ventilator free days [ Time Frame: 28 days ]
Ventilator free days (VFDs) will be calculated in a time frame of 28 days, the beginning of observation will coincide with the day of intubation and observation will end after successful disconnection from mechanical ventilation.
For intubated patients, post extubation non invasive ventilation (NIV) will not be accounted as a ventilation period, in case of interval reintubation within 28 days, VFDs will be counted from the last successful extubation.
For tracheostomized patients, ventilator free days will be counted after successful disconnection from mechanical ventilation and interval reconnections will be considered in the ventilation interval as for intubated patients.
- ICU Mortality [ Time Frame: 60 days ]
- 30 days survival after ICU discharge [ Time Frame: 30 days ]
- 90 days survival after ICU discharge [ Time Frame: 90 days ]
- Quality of life at 90 days after ICU discharge measured with 15D instrument [ Time Frame: 90 days ]
15D instrument (http://www.15d-instrument.net/15d/) will be administered via telephonic interview
Areas assessed: MOBILITY, VISION, HEARING, BREATHING, SLEEPING, EATING, SPEECH, EXCRETION, USUAL ACTIVITIES, MENTAL FUNCTION, DISCOMFORT AND SYMPTOMS, DEPRESSION, DISTRESS, VITALITY, SEXUAL ACTIVITY
- Radiologic aspects - structured description of CT and RX data [ Time Frame: 90 days ]
First available CT, last CT before ICU admission and intubation, last ICU follow-up CT. First available chest X ray, last chest X ray before ICU admission and intubation, last ICU- follow up chest X ray and 30 days follow-up CT (if available) will be evaluated, if available.
Date: yyyy/mm/dd Parenchymal alterations: ground glass, crazy paving, parenchymal consolidation Extension: monolateral, bilateral Number of lobes involved: (1-5) Percentage of parenchymal involvement: 0-100% Distribution: subpleural, random, diffuse
Date: yyyy/mm/dd Main aspects: normal, focal lesions, monolateral multifocal lesions (right/left), diffuse multifocal lesions Lesion aspects: interstitial, interstitial/alveolar, alveolar, consolidations Pleural effusion presence and entity
Pulmonary involvement score:
0 = no involvement
- =< 25%
- = 25-50% 3= 50-75%
4 => 75% Total score (0-6): score of the right lung + score of the left lung
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): NCT04411459
|Contact: Lorenzo Gamberini, MDfirstname.lastname@example.org|