COVID-19 Clinical Trial
Official title:
Risk Factors for Prolonged Invasive Mechanical Ventilation in COVID-19 Acute Respiratory Distress Syndrome
Verified date | August 2021 |
Source | Azienda Usl di Bologna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 470 |
Est. completion date | October 16, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Italy | A.O. SS. Antonio, Biagio e Cesare Arrigo - Anestesia e Rianimazione | Alessandria | |
Italy | Anestesia e Rianimazione - Ospedale Civile di Baggiovara | Baggiovara | |
Italy | Ospedale Santa Maria Annunziata - Anestesia e Rianimazione | Bagno A Ripoli | FI |
Italy | Anestesia e Rianimazione - Ospedale di Bentivoglio | Bentivoglio | |
Italy | Anestesia e Rianimazione - Ospedale Bellaria | Bologna | |
Italy | Anestesia e Rianimazione - Policlinico Universitario S.Orsola - Malpighi | Bologna | |
Italy | Anestesia e Terapia intensiva dei trapianti addominali e chirurgia epatobiliare - Policlinico Universitario S.Orsola - Malpighi | Bologna | |
Italy | Anestesia e Terapia Intensiva Polivalente - Policlinico Universitario S.Orsola - Malpighi | Bologna | |
Italy | Azienda Unità Sanitaria Locale | Bologna | |
Italy | Ospedale SS. Trinità - Anestesia e Rianimazione | Borgomanero | |
Italy | Anestesia e Rianimazione - Ospedale M. Bufalini | Cesena | |
Italy | Anestesia e Rianimazione - Ospedale degli Infermi | Faenza | |
Italy | Anestesia e Rianimazione Universitaria - Arcispedale Sant'Anna Ferrara | Ferrara | |
Italy | Anestesia e Rianimazione - Ospedale Morgagni - Pierantoni | Forlì | |
Italy | Anestesia e Rianimazione - Ospedale di Imola S.Maria della Scaletta | Imola | |
Italy | Ospedale Santo Stefano - Anestesia e Rianimazione | Prato | |
Italy | Anestesia e Rianimazione - Ospedale S. Maria delle Croci | Ravenna | |
Italy | Anestesia e Rianimazione - Arcispedale Santa Maria Nuova | Reggio Emilia | |
Italy | Anestesia e Rianimazione - Ospedale di Riccione | Riccione | |
Italy | Anestesia e Rianimazione - Ospedale Infermi | Rimini |
Lead Sponsor | Collaborator |
---|---|
Azienda Usl di Bologna | Lorenzo Gamberini |
Italy,
Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region — View Citation
Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. — View Citation
Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lomb — View Citation
Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium, Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Haji — View Citation
Yehya N, Harhay MO, Curley MAQ, Schoenfeld DA, Reeder RW. Reappraisal of Ventilator-Free Days in Critical Care Research. Am J Respir Crit Care Med. 2019 Oct 1;200(7):828-836. doi: 10.1164/rccm.201810-2050CP. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of mechanical ventilation and 28 days ventilator free 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. |
28 days | |
Secondary | ICU Mortality | 60 days | ||
Secondary | 30 days survival after ICU discharge | 30 days | ||
Secondary | 90 days survival after ICU discharge | 90 days | ||
Secondary | Quality of life at 90 days after ICU discharge measured with 15D instrument | 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 |
90 days | |
Secondary | Radiologic aspects - structured description of CT and RX data | 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 |
90 days | |
Secondary | Quality of life at 1 year after ICU discharge and persistent symptoms | 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 |
1 year | |
Secondary | Radiologic aspects at 1 year CT scan | Presence and extension of pulmonary fibrosing and non fibrosing signs | 1 year | |
Secondary | Pulmonary function tests at 1 year - FEV1% | FEV1% - Forced expiratory volume 1 second, % of predicted value referred to normative population | 1 year | |
Secondary | Pulmonary function tests at 1 year - FVC% | FVC% - Forced vital capacity, % of predicted value referred to normative population | 1 year | |
Secondary | Pulmonary function tests at 1 year - FEV1/FVC% | FEV1/FVC% - Forced expiratory volume 1 second/Forced Vital capacity, % of predicted value referred to normative population | 1 year | |
Secondary | Pulmonary function tests at 1 year - | DLCO% - Diffusing capacity for carbon monoxide, % of predicted value referred to normative population | 1 year |
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