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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

Tracking Information
First Submitted Date May 29, 2020
First Posted Date June 2, 2020
Last Update Posted Date August 30, 2021
Actual Study Start Date February 1, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 1, 2020)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 27, 2021)
  • 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
    1. =< 25%
    2. = 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
Original Secondary Outcome Measures
 (submitted: June 1, 2020)
  • 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
    1. =< 25%
    2. = 25-50% 3= 50-75%
    4 => 75% Total score (0-6): score of the right lung + score of the left lung
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk Factors for Prolonged Invasive Mechanical Ventilation in COVID-19 Acute Respiratory Distress Syndrome
Official Title Risk Factors for Prolonged Invasive Mechanical Ventilation in COVID-19 Acute Respiratory Distress Syndrome
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.
Detailed Description

Background

On February 21th 2020, SARS-CoV-2 outbreak erupted in Italy and, in the immediately subsequent period, all the Italian regional Health Systems had to face with an overwhelming increase of COVID-19 admissions requiring isolation, oxygen, ventilation and ICU beds.

The COVID-19 related pneumonia presented as a particular entity in terms of clinical management and different ICUs adopt different clinical strategies, sometimes this is due to the local resources' availability. Mortality rate of the patients admitted to ICU is up to 26%.

To date, it is not clear which clinical, pharmacological and radiologic factors relate to a prolonged duration of mechanical ventilation, mortality and ICU length of stay and it's urgent to understand these aspects in order to develop optimal strategies to allow faster but safe paths for these patients.

Hypothesis and significance

SARS-CoV-2 related pneumonia ICU management is still undefined, in fact this entity seems to have clinical aspects rather different from other forms of interstitial pulmonary syndromes evolving in diffuse alveolar damage and many aspects related to ventilation such pulmonary compliance, driving pressure and response to pronation are very different from what traditionally observed from other forms of ARDS, moreover an abnormal trend towards hypercoagulability has been described in these patients.

Different treatments have been proposed and are under evaluation such as Tocilizumab, corticosteroids, hydroxychloroquine, antivirals, anticoagulants and antiplatelet therapies.

These treatments, together with common ICU practice aspects such as early/late tracheostomy, ventilatory parameters believed adequate in order to start a weaning procedure, fluidic balance, choice of analgesia and sedation regimens, are not standardized in this particular syndrome due to the lack of evidence available and there is need for information about which factors correlate to a lower duration of mechanical ventilation and mortality.

Collected data:

  • Demographics and anamnesis: age, sex, weight, height, previous pathologies (Hypertension, Chronic ischemic heart disease, Chronic kidney disease, COPD, Diabetes, Chronic liver disease, active cancer, immunosuppressive therapy), smoker status, therapy with ACE-inhibitors, statins and Angiotensin II Receptor Blockers.
  • Conditions at ICU admission: date of symptoms onset (fever and or cough), date of hospital admission, date of ICU admission, SOFA and SAPS II score, high flow nasal oxygen therapy before intubation, NIV/CPAP trial before intubation, duration of the NIV/CPAP trial, PaO2/FiO2 value before intubation, initial tidal volume set, initial PEEP set, Initial pplateau observed.
  • Ventilation during the first 5 days: lowest PaO2/FiO2 value, ventilatory strategy (pressure control ventilation vs volume control ventilation and volumes), lowest static respiratory system compliance, highest driving pressure, highest PEEP, highest arterial pCO2 observed, number and duration of pronation cycles, response in terms of oxygenation to the first pronation, need for decapneization, use of nitric oxide, tracheostomy date, need for extracorporeal membrane oxygenation treatment.
  • Pharmacologic strategies during the first 5 days: sedative regimen and maximum doses, neuromuscular blocking agents (type of NMBA and duration of continuous infusion).
  • COVID specific therapies: antivirals (type, start and end date), chloroquine, tocilizumab (start date and route of administration), intravenous corticosteroids, other specific therapies.
  • Other supportive therapies: first line antibacterial regimen, amines (maximum dose), renal replacement therapy, fluidic balance during the first 3 days after ICU admission, anticoagulation, antiaggregation.
  • Complications during ICU stay:

    • Cardiovascular (myocardial infarction, new onset supraventricular or ventricular arrhythmia, pulmonary embolism, pulmonary edema, haemorragic shock, cardiogenic shock, acute peripheral ischemia, pneumothorax)
    • Neurologic (new onset ischemic stroke or cerebral haemorrage, critical illness polyneuropathy / myopathy, new onset seizures)
    • Gastroenteric (gastrointestinal bleeding, severe diarrhea, intestinal occlusion, gastrointestinal perforation/ischemia)
    • Extrapulmonary infections (documented blood steam, urinary tract, central nervous system, abdominal infection)
    • Pulmonary infections after intubation (early onset VAP - < 7 days of mechanical ventilation, late onset VAP - ≥ 7 days of mechanical ventilation)
  • Weaning from mechanical ventilation: last day of highest PEEP, first attempt of pressure support ventilation (PSV), P/F at the first attempt of PSV, entity of pressure support at the first attempt of PSV, PEEP at the first attempt of PSV, day of extubation, non-invasive ventilation or high flow oxygen therapy after extubation, first day of spontaneous breathing, need for reintubation and date
  • Radiology: 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. 30 days follow-up CT (if available).
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • COVID-19
  • Mechanical Ventilation
  • Quality of Life
  • Radiologic Increased Density of Lung
  • Sedation
  • Complication of Treatment
Intervention Other: Invasive mechanical ventilation
Invasive mechanical ventilation for respiratory failure associated to COVID-19 pneumonia
Study Groups/Cohorts COVID-19 pneumonia patients
Patients needing intubation and mechanical ventilation for COVID-19 related pneumonia without other primary causes of ICU admission
Intervention: Other: Invasive mechanical ventilation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 16, 2020)
470
Original Estimated Enrollment
 (submitted: June 1, 2020)
600
Actual Study Completion Date October 16, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04411459
Other Study ID Numbers 273/2020/OSS/AUSLBO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Azienda Usl di Bologna
Original Responsible Party Same as current
Current Study Sponsor Azienda Usl di Bologna
Original Study Sponsor Same as current
Collaborators Lorenzo Gamberini
Investigators Not Provided
PRS Account Azienda Usl di Bologna
Verification Date August 2021