Risk Factors for Prolonged Invasive Mechanical Ventilation in COVID-19 Acute Respiratory Distress Syndrome
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ClinicalTrials.gov Identifier: NCT04411459 |
Recruitment Status :
Completed
First Posted : June 2, 2020
Last Update Posted : August 30, 2021
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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 |
Actual Enrollment : | 470 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |
Actual Study Completion Date : | October 16, 2020 |

Group/Cohort | Intervention/treatment |
---|---|
COVID-19 pneumonia patients
Patients needing intubation and mechanical ventilation for COVID-19 related pneumonia without other primary causes of ICU admission
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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.
Structured description
CT scan
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
X-ray scan
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
- Quality of life at 1 year after ICU discharge and persistent symptoms [ Time Frame: 1 year ]
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
Persistent symptoms explored: Dyspnea measured with mMRC scale, palpitations, cough, arthromyalgia
- Radiologic aspects at 1 year CT scan [ Time Frame: 1 year ]Presence and extension of pulmonary fibrosing and non fibrosing signs
- Pulmonary function tests at 1 year - FEV1% [ Time Frame: 1 year ]FEV1% - Forced expiratory volume 1 second, % of predicted value referred to normative population
- Pulmonary function tests at 1 year - FVC% [ Time Frame: 1 year ]FVC% - Forced vital capacity, % of predicted value referred to normative population
- Pulmonary function tests at 1 year - FEV1/FVC% [ Time Frame: 1 year ]FEV1/FVC% - Forced expiratory volume 1 second/Forced Vital capacity, % of predicted value referred to normative population
- Pulmonary function tests at 1 year - [ Time Frame: 1 year ]DLCO% - Diffusing capacity for carbon monoxide, % of predicted value referred to normative population

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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 |
Inclusion Criteria:
- Age ≥ 18 years
- ICU admission because of the need of mechanical ventilation in the context of COVID-19 related pneumonia (swab proven)
Exclusion Criteria:
- COVID-19 related pneumonia complicating the clinical course of patients admitted to the ICU for another reason (e.g. trauma, stroke)

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

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Azienda Usl di Bologna |
ClinicalTrials.gov Identifier: | NCT04411459 |
Other Study ID Numbers: |
273/2020/OSS/AUSLBO |
First Posted: | June 2, 2020 Key Record Dates |
Last Update Posted: | August 30, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Mechanical Ventilation Quality of life Complications during ICU stay |
COVID-19 Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Acute Lung Injury Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections |
Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury |