Ventilatory Efficiency in Critically Ill COVID-19 Patients
NCT ID: NCT04694742
Last Updated: 2021-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2020-09-01
2021-04-15
Brief Summary
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Pulmonary involvement causes predominantly hypoxemic respiratory failure. Although COVID-19 pneumonia often falls within the diagnostic criteria of ARDS, it differs from it for some peculiar pathophysiological characteristics. In particular, patients with ARDS secondary to COVID-19 often have the compliance of the respiratory system within the normal range. A significant role in the pathophysiology of hypoxemia seems to depend on vascular alterations such as altered pulmonary vascular self-regulation, pulmonary capillary leakage, and microvascular thrombosis in a complex process known as "immunothrombosis". All together they act by altering the relationship between ventilation and perfusion and increasing the dead space, which ultimately results in impaired efficiency of the pulmonary ventilation. Among the various markers associated with the prognosis of patients with COVID-19, D-dimer is linked to both the inflammatory state and thrombotic phenomena and could help to identify patients at greater risk of developing early ventilation-perfusion changes.
This study aims at measuring the ventilatory efficiency, assessed by Ventilatory Ratio, in critically ill, mechanically ventilated, COVID-19 patients and its correlation with plasma D-dimer and quasi-static respiratory compliance.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ARDS COVID-19
Patients who meet Berlin's ARDS diagnostic criteria, with confirmed SARS-CoV-2 infection, requiring invasive mechanical ventilation.
data collecting
Within 24h from ICU admission, the ventilatory efficiency will be assessed by the following Ventilatory Ratio equation:
Ventilatory Ratio = \[minute ventilation (ml/min) × PaCO2 (mm Hg)\]/(predicted body weight × 100 × 37.5).
Where PaCO2 is the partial pressure of carbon dioxide in mmHg in the arterial blood.
Tha quasi-static compliance will be calculated according to the equation:
C=Tidal Volume/(Paw plateau - PEEP total)
where Paw plateau is the airway pressure measured during 4 seconds of inspiratory pause, PEEP total is the airway pressure measured during 4 seconds of expiratory pause.
In the same time frame, complete blood count, d-dimer, sequential organ failure assessment score, blood gas analysis, haemodynamic and ventilatory parameters will be collected.
Interventions
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data collecting
Within 24h from ICU admission, the ventilatory efficiency will be assessed by the following Ventilatory Ratio equation:
Ventilatory Ratio = \[minute ventilation (ml/min) × PaCO2 (mm Hg)\]/(predicted body weight × 100 × 37.5).
Where PaCO2 is the partial pressure of carbon dioxide in mmHg in the arterial blood.
Tha quasi-static compliance will be calculated according to the equation:
C=Tidal Volume/(Paw plateau - PEEP total)
where Paw plateau is the airway pressure measured during 4 seconds of inspiratory pause, PEEP total is the airway pressure measured during 4 seconds of expiratory pause.
In the same time frame, complete blood count, d-dimer, sequential organ failure assessment score, blood gas analysis, haemodynamic and ventilatory parameters will be collected.
Eligibility Criteria
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Inclusion Criteria
* confirmed SARS-CoV-2 infection by RT-PCR on a nasopharyngeal swab
* severe hypoxemia due to COVID-19 who meets the diagnostic criteria of ARDS (Berlin's definition)
* invasive mechanical ventilation
* patients receiving neuromuscular blocking drugs
Exclusion Criteria
* severe haemodynamic instability defined as:
* Mean arterial pressure \< 65 mmHg despite the infusion of norepinephrine, or epinephrine, or dobutamine, or levosimendan
* severe left ventricular dysfunction with ejection fraction \<20%
* right ventricular failure due to pulmonary embolism
18 Years
90 Years
ALL
No
Sponsors
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Ospedale Infermi Rimini
UNKNOWN
S. Anna Hospital
OTHER
Azienda Ospedaliero, Universitaria Ospedali Riuniti
OTHER
ASST Fatebenefratelli Sacco
OTHER
Responsible Party
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Riccardo Colombo
MD
Principal Investigators
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Riccardo Colombo, M.D.
Role: PRINCIPAL_INVESTIGATOR
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
Locations
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Arcispedale Sant'Anna
Ferrara, Emilia-Romagna, Italy
Ospedale Infermi
Rimini, Emilia-Romagna, Italy
ASST Fatebenefratelli Sacco
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
Ancona, The Marches, Italy
Countries
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Central Contacts
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Andrea Agarossi, M.D.
Role: CONTACT
Facility Contacts
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References
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WHO Weekly epidemiological update - 29 December 2020 - https://www.who.int/publications/m/item/weekly-epidemiological-update---29-december-2020
Sinha P, Calfee CS, Beitler JR, Soni N, Ho K, Matthay MA, Kallet RH. Physiologic Analysis and Clinical Performance of the Ventilatory Ratio in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2019 Feb 1;199(3):333-341. doi: 10.1164/rccm.201804-0692OC.
ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
Other Identifiers
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VentRatio-19
Identifier Type: -
Identifier Source: org_study_id
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