COVID-19NCT04411459
Risk Factors for Prolonged Invasive Mechanical Ventilation in COVID-19 Acute Respiratory Distress Syndrome
An observational study of COVID-19 and Mechanical Ventilation, run by Azienda Usl di Bologna at 20 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Mechanical Ventilation, Quality of Life
- What is being tested?
- Invasive mechanical ventilation
- How many people
- 470 participants
- Where
- 20 sitesItaly
- Study dates
- 1 Feb 2020to 16 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Age ≥ 18 years
- ICU admission because of the need of mechanical ventilation in the context of COVID-19 related pneumonia (swab proven)
Who cannot join
- COVID-19 related pneumonia complicating the clinical course of patients admitted to the ICU for another reason (e.g. trauma, stroke)
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
A.O. SS. Antonio, Biagio e Cesare Arrigo - Anestesia e Rianimazione
Alessandria
Anestesia e Rianimazione - Ospedale Civile di Baggiovara
Baggiovara
Ospedale Santa Maria Annunziata - Anestesia e Rianimazione
Bagno a Ripoli, FI
Anestesia e Rianimazione - Ospedale di Bentivoglio
Bentivoglio
Azienda Unità Sanitaria Locale
Bologna, 40100
Anestesia e Rianimazione - Ospedale Bellaria
Bologna
Anestesia e Rianimazione - Policlinico Universitario S.Orsola - Malpighi
Bologna
Anestesia e Terapia intensiva dei trapianti addominali e chirurgia epatobiliare - Policlinico Universitario S.Orsola - Malpighi
Bologna
Anestesia e Terapia Intensiva Polivalente - Policlinico Universitario S.Orsola - Malpighi
Bologna
Ospedale SS. Trinità - Anestesia e Rianimazione
Borgomanero
Anestesia e Rianimazione - Ospedale M. Bufalini
Cesena
Anestesia e Rianimazione - Ospedale degli Infermi
Faenza
Anestesia e Rianimazione Universitaria - Arcispedale Sant'Anna Ferrara
Ferrara
Anestesia e Rianimazione - Ospedale Morgagni - Pierantoni
Forlì
Anestesia e Rianimazione - Ospedale di Imola S.Maria della Scaletta
Imola
Ospedale Santo Stefano - Anestesia e Rianimazione
Prato
Anestesia e Rianimazione - Ospedale S. Maria delle Croci
Ravenna
Anestesia e Rianimazione - Arcispedale Santa Maria Nuova
Reggio Emilia
Anestesia e Rianimazione - Ospedale di Riccione
Riccione
Anestesia e Rianimazione - Ospedale Infermi
Rimini
About this study
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.
Read the 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).
- Conditions
- COVID-19, Mechanical Ventilation, Quality of Life, Radiologic Increased Density of Lung, Sedation, Complication of Treatment
- Being tested
- Invasive mechanical ventilation
- Keywords
- COVID-19, Mechanical Ventilation, Quality of life, Complications during ICU stay
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive mechanical ventilationOther
Invasive mechanical ventilation for respiratory failure associated to COVID-19 pneumonia
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 pneumonia patients | Patients needing intubation and mechanical ventilation for COVID-19 related pneumonia without other primary causes of ICU admission Receives: Other: Invasive mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (11)
ICU Mortality
Measured: 60 days
30 days survival after ICU discharge
Measured: 30 days
90 days survival after ICU discharge
Measured: 90 days
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
Measured: 90 days
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
Measured: 90 days
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
Measured: 1 year
Radiologic aspects at 1 year CT scan
Presence and extension of pulmonary fibrosing and non fibrosing signs
Measured: 1 year
Pulmonary function tests at 1 year - FEV1%
FEV1% - Forced expiratory volume 1 second, % of predicted value referred to normative population
Measured: 1 year
Pulmonary function tests at 1 year - FVC%
FVC% - Forced vital capacity, % of predicted value referred to normative population
Measured: 1 year
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
Measured: 1 year
Pulmonary function tests at 1 year -
DLCO% - Diffusing capacity for carbon monoxide, % of predicted value referred to normative population
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Feb 2020
- Primary completion30 Jun 2020
- Study completion16 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Collaborators
- Lorenzo Gamberini
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411459
- Sponsor's protocol ID
- 273/2020/OSS/AUSLBO
- Status last verified
- Aug 2021
- First submitted
- 29 May 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31034248Gattinoni 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. No abstract available.
PubMed 32291463Grasselli 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 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.
PubMed 32250385Bhatraju 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 - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30.
PubMed 32227758Richardson 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, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.
PubMed 32320003Dalpiaz G, Gamberini L, Carnevale A, Spadaro S, Mazzoli CA, Piciucchi S, Allegri D, Capozzi C, Neziri E, Bartolucci M, Muratore F, Coppola F, Poerio A, Giampalma E, Baldini L, Tonetti T, Cappellini I, Colombo D, Zani G, Mellini L, Agnoletti V, Damiani F, Gordini G, Laici C, Gola G, Potalivo A, Montomoli J, Ranieri VM, Russo E, Taddei S, Volta CA, Scaramuzzo G. Clinical implications of microvascular CT scan signs in COVID-19 patients requiring invasive mechanical ventilation. Radiol Med. 2022 Feb;127(2):162-173. doi: 10.1007/s11547-021-01444-7. Epub 2022 Jan 16.
PubMed 35034320Gamberini 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.
PubMed 34717097Gamberini L, Mazzoli CA, Sintonen H, Colombo D, Scaramuzzo G, Allegri D, Tonetti T, Zani G, Capozzi C, Giampalma E, Agnoletti V, Becherucci F, Bertellini E, Castelli A, Cappellini I, Cavalli I, Crimaldi F, Damiani F, Fusari M, Gordini G, Laici C, Lanza MC, Leo M, Marudi A, Nardi G, Ottaviani I, Papa R, Potalivo A, Ranieri VM, Russo E, Taddei S, Volta CA, Spadaro S; ICU-RER COVID-19 Collaboration. Quality of life of COVID-19 critically ill survivors after ICU discharge: 90 days follow-up. Qual Life Res. 2021 Oct;30(10):2805-2817. doi: 10.1007/s11136-021-02865-7. Epub 2021 May 12.
PubMed 33977415Gamberini L, Tonetti T, Spadaro S, Zani G, Mazzoli CA, Capozzi C, Giampalma E, Bacchi Reggiani ML, Bertellini E, Castelli A, Cavalli I, Colombo D, Crimaldi F, Damiani F, Fogagnolo A, Fusari M, Gamberini E, Gordini G, Laici C, Lanza MC, Leo M, Marudi A, Nardi G, Ottaviani I, Papa R, Potalivo A, Russo E, Taddei S, Volta CA, Ranieri VM; ICU-RER COVID-19 Collaboration. Factors influencing liberation from mechanical ventilation in coronavirus disease 2019: multicenter observational study in fifteen Italian ICUs. J Intensive Care. 2020 Oct 15;8:80. doi: 10.1186/s40560-020-00499-4. eCollection 2020.
PubMed 33078076
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Prolonged Invasive Mechanical Ventilation in COVID-19 Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT04411459
- Acronym / sponsor ID
- 273/2020/OSS/AUSLBO
- Conditions
- COVID-19, Mechanical Ventilation, Quality of Life, Radiologic Increased Density of Lung, Sedation, Complication of Treatment
- Keywords
- COVID-19, Mechanical Ventilation, Quality of life, Complications during ICU stay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Collaborators
- Lorenzo Gamberini
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 pneumonia patients | – | Other: Invasive mechanical ventilationPatients needing intubation and mechanical ventilation for COVID-19 related pneumonia without other primary causes of ICU admission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- ICU admission because of the need of mechanical ventilation in the context of COVID-19 related pneumonia (swab proven)
Key exclusion criteria (1 listed)
- COVID-19 related pneumonia complicating the clinical course of patients admitted to the ICU for another reason (e.g. trauma, stroke)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive mechanical ventilationInvasive mechanical ventilation for respiratory failure associated to COVID-19 pneumonia | Other | COVID-19 pneumonia patients |
Primary outcome
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.
11 secondary outcomes
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
Radiologic aspects - structured description of CT and RX data
Time frame: 90 days
Quality of life at 1 year after ICU discharge and persistent symptoms
Time frame: 1 year
Radiologic aspects at 1 year CT scan
Time frame: 1 year
Pulmonary function tests at 1 year - FEV1%
Time frame: 1 year
Pulmonary function tests at 1 year - FVC%
Time frame: 1 year
Pulmonary function tests at 1 year - FEV1/FVC%
Time frame: 1 year
Pulmonary function tests at 1 year -
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Background: PubMed 31034248Yehya 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.
- Background: PubMed 32291463Gattinoni 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. No abstract available.
- Results publication: PubMed 32250385Grasselli 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 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.
- Results publication: PubMed 32227758Bhatraju 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 - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30.
- Results publication: PubMed 32320003Richardson 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, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.
- Derived from this study: PubMed 35034320Dalpiaz G, Gamberini L, Carnevale A, Spadaro S, Mazzoli CA, Piciucchi S, Allegri D, Capozzi C, Neziri E, Bartolucci M, Muratore F, Coppola F, Poerio A, Giampalma E, Baldini L, Tonetti T, Cappellini I, Colombo D, Zani G, Mellini L, Agnoletti V, Damiani F, Gordini G, Laici C, Gola G, Potalivo A, Montomoli J, Ranieri VM, Russo E, Taddei S, Volta CA, Scaramuzzo G. Clinical implications of microvascular CT scan signs in COVID-19 patients requiring invasive mechanical ventilation. Radiol Med. 2022 Feb;127(2):162-173. doi: 10.1007/s11547-021-01444-7. Epub 2022 Jan 16.
- Derived from this study: PubMed 34717097Gamberini 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.
- Derived from this study: PubMed 33977415Gamberini L, Mazzoli CA, Sintonen H, Colombo D, Scaramuzzo G, Allegri D, Tonetti T, Zani G, Capozzi C, Giampalma E, Agnoletti V, Becherucci F, Bertellini E, Castelli A, Cappellini I, Cavalli I, Crimaldi F, Damiani F, Fusari M, Gordini G, Laici C, Lanza MC, Leo M, Marudi A, Nardi G, Ottaviani I, Papa R, Potalivo A, Ranieri VM, Russo E, Taddei S, Volta CA, Spadaro S; ICU-RER COVID-19 Collaboration. Quality of life of COVID-19 critically ill survivors after ICU discharge: 90 days follow-up. Qual Life Res. 2021 Oct;30(10):2805-2817. doi: 10.1007/s11136-021-02865-7. Epub 2021 May 12.
- Derived from this study: PubMed 33078076Gamberini L, Tonetti T, Spadaro S, Zani G, Mazzoli CA, Capozzi C, Giampalma E, Bacchi Reggiani ML, Bertellini E, Castelli A, Cavalli I, Colombo D, Crimaldi F, Damiani F, Fogagnolo A, Fusari M, Gamberini E, Gordini G, Laici C, Lanza MC, Leo M, Marudi A, Nardi G, Ottaviani I, Papa R, Potalivo A, Russo E, Taddei S, Volta CA, Ranieri VM; ICU-RER COVID-19 Collaboration. Factors influencing liberation from mechanical ventilation in coronavirus disease 2019: multicenter observational study in fifteen Italian ICUs. J Intensive Care. 2020 Oct 15;8:80. doi: 10.1186/s40560-020-00499-4. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Mechanical Ventilation, run by Azienda Usl di Bologna at 20 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of mechanical ventilation and 28 days ventilator free days (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04411459, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.