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Risk Factors for Prolonged Invasive Mechanical Ventilation in COVID-19 Acute Respiratory Distress Syndrome

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: NCT04411459
Recruitment Status : Completed
First Posted : June 2, 2020
Last Update Posted : August 30, 2021
Sponsor:
Collaborator:
Lorenzo Gamberini
Information provided by (Responsible Party):
Azienda Usl di Bologna

Brief Summary:
This multicentric prospective clinical practice study aims at evaluating clinical factors associated with a prolonged invasive mechanical ventilation and other outcomes such as mortality and ICU length of stay in patients affected from COVID-19 related pneumonia and ARDS.

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

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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
Other: Invasive mechanical ventilation
Invasive mechanical ventilation for respiratory failure associated to COVID-19 pneumonia




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. ICU Mortality [ Time Frame: 60 days ]
  2. 30 days survival after ICU discharge [ Time Frame: 30 days ]
  3. 90 days survival after ICU discharge [ Time Frame: 90 days ]
  4. 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


  5. 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

    1. =< 25%
    2. = 25-50% 3= 50-75%

    4 => 75% Total score (0-6): score of the right lung + score of the left lung


  6. 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


  7. Radiologic aspects at 1 year CT scan [ Time Frame: 1 year ]
    Presence and extension of pulmonary fibrosing and non fibrosing signs

  8. Pulmonary function tests at 1 year - FEV1% [ Time Frame: 1 year ]
    FEV1% - Forced expiratory volume 1 second, % of predicted value referred to normative population

  9. Pulmonary function tests at 1 year - FVC% [ Time Frame: 1 year ]
    FVC% - Forced vital capacity, % of predicted value referred to normative population

  10. 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

  11. Pulmonary function tests at 1 year - [ Time Frame: 1 year ]
    DLCO% - Diffusing capacity for carbon monoxide, % of predicted value referred to normative population



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
This study enrolls patients admitted to ICU needing intubation and mechanical ventilation bacause of respiratory failure for COVID-19 pneumonia without other primary causes for ICU admission
Criteria

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)

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): NCT04411459


Locations
Show Show 20 study locations
Sponsors and Collaborators
Azienda Usl di Bologna
Lorenzo Gamberini
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Gamberini L, Mazzoli CA, Prediletto I, Sintonen H, Scaramuzzo G, Allegri D, Colombo D, Tonetti T, Zani G, Capozzi C, Dalpiaz G, Agnoletti V, Cappellini I, Melegari G, Damiani F, Fusari M, Gordini G, Laici C, Lanza MC, Leo M, Marudi A, Papa R, Potalivo A, Montomoli J, Taddei S, Mazzolini M, Ferravante AF, Nicali R, Ranieri VM, Russo E, Volta CA, Spadaro S; ICU-RER COVID-19 Collaboration; Radiology Collaborators (to be indexed and searchable into PubMed); Pneumology Collaborators (to be indexed and searchable into PubMed). Health-related quality of life profiles, trajectories, persistent symptoms and pulmonary function one year after ICU discharge in invasively ventilated COVID-19 patients, a prospective follow-up study. Respir Med. 2021 Nov-Dec;189:106665. doi: 10.1016/j.rmed.2021.106665. Epub 2021 Oct 22.

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Azienda Usl di Bologna:
COVID-19
Mechanical Ventilation
Quality of life
Complications during ICU stay
Additional relevant MeSH terms:
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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