Ventilatory Efficiency in Critically Ill COVID-19 Patients

ARDS Clinical Trial

Official title:

Ventilatory Efficiency in Critically Ill COVID-19 Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04694742
• Other study ID #: VentRatio-19
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: April 15, 2021

Study information

• Verified date: January 2021
• Source: ASST Fatebenefratelli Sacco
• Contact: Riccardo Colombo, M.D.
• Phone: +390239043023
• Email: riccardo.colombo[@]asst-fbf-sacco.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The new severe acute respiratory syndrome coronavirus 2019 (SARS-CoV-2) causes the illness named COVID-19, which is primarily characterized by pneumonia. As of 27 December, there have been over 79.2 million cases and over 1.7 million deaths reported since the start of the pandemic. In many cases, pneumonia evolves to acute respiratory distress syndrome (ARDS) with the need for mechanical ventilation and patient admission to intensive care unit, determining a marked increase in the need for intensive care beds worldwide. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 15, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

All of the following:

• 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:

• history of preexisting severe hypoxemia (i.e. primary pulmonary hypertension, COPD in therapy with O2 supplementation, pulmonary fibrosis, etc.)
• 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

Related Conditions & MeSH terms

• ARDS
• Critical Illness

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti	Ancona	Marche
Italy	Arcispedale Sant'Anna	Ferrara	Emilia Romagna
Italy	ASST Fatebenefratelli Sacco	Milan	Lombardy
Italy	Ospedale Infermi	Rimini	Emilia Romagna

Sponsors (4)

Lead Sponsor	Collaborator
ASST Fatebenefratelli Sacco	Azienda Ospedaliero, Universitaria Ospedali Riuniti, Ospedale Infermi Rimini, S. Anna Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

WHO Weekly epidemiological update - 29 December 2020 - https://www.who.int/publications/m/item/weekly-epidemiological-update---29-december-2020

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilatory ratio correlation	Measure the correlation between ventilatory ratio, plasma D-dimer, and quasi-static compliance of the respiratory system	24 hours from ICU admission
Secondary	Mortality	Mortality among subgroups stratified according to Ventilatory ratio and quasi-static respiratory compliance. Subgroup will be identified according centiles of the distribution values of 1) Ventilatory Ratio, and 2) quasi-static compliance both measured in the first 24 hours.	30 days