Ventilatory Efficiency in Critically Ill COVID-19 Patients

NCT04694742 | Unknown

• 1 other identifier: VentRatio-19
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

ARDS

Keywords

Ventilatory ratio; Mechanical ventilation; ARDS; COVID-19; Critical illness; Dead-space

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mortality

  30 days

Study Arms (1)

ARDS COVID-19

Patients who meet Berlin's ARDS diagnostic criteria, with confirmed SARS-CoV-2 infection, requiring invasive mechanical ventilation.

Other: data collecting

Interventions

data collecting OTHER

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.

ARDS COVID-19

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients consecutively admitted to ICU with the eligibility criteria will be enrolled in the study. They will be treated according to the standard of care.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: lead
• Ospedale Infermi Rimini: collaborator
• S. Anna Hospital: collaborator
• Azienda Ospedaliero, Universitaria Ospedali Riuniti: collaborator

Study Sites (4)

Arcispedale Sant'Anna

Ferrara, Emilia-Romagna, 44124, Italy

NOT YET RECRUITING

Ospedale Infermi

Rimini, Emilia-Romagna, 47923, Italy

NOT YET RECRUITING

ASST Fatebenefratelli Sacco

Milan, Lombardy, 20157, Italy

RECRUITING

Azienda Ospedaliero Universitaria Ospedali Riuniti

Ancona, The Marches, 60126, Italy

RECRUITING

Related Publications (3)

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

  BACKGROUND

• 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.

  PMID: 30211618 BACKGROUND

• 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.

  PMID: 22797452 BACKGROUND

MeSH Terms

Conditions

COVID-19; Critical Illness

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Riccardo Colombo, M.D.

  ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Riccardo Colombo, M.D.

CONTACT

+390239043023; riccardo.colombo@asst-fbf-sacco.it

Andrea Agarossi, M.D.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: January 5, 2021
• Study Start: September 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: April 15, 2021
• Last Updated: January 5, 2021

Record last verified: 2021-01

Locations

IT (4)