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).

Completed
COVID-19
Mechanical Ventilation
Quality of Life
Radiologic Increased Density of Lung
Sedation
Complication of Treatment

Other: Invasive mechanical ventilation

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

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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Italy
Locations

Ospedale Santa Maria Annunziata - Anestesia e Rianimazione
Bagno A Ripoli, FI, Italy

A.O. SS. Antonio, Biagio e Cesare Arrigo - Anestesia e Rianimazione
Alessandria, Italy

Anestesia e Rianimazione - Ospedale Civile di Baggiovara
Baggiovara, Italy

Anestesia e Rianimazione - Ospedale di Bentivoglio
Bentivoglio, Italy

Azienda Unità Sanitaria Locale
Bologna, 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

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, Italy

Lorenzo Gamberini
NCT Number
Keywords
Covid-19
Mechanical Ventilation
Quality of Life
Complications during ICU stay
MeSH Terms
COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury