Hemodynamic Impact on Critical Care Patients With Lung Damage Secondary to COVID-19

Juan Victor Lorente

Status: Unknown

Conditions: Hemodynamic Instability; Covid19; ARDS, Human

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04556864

FAB-HEM-2020-01

Details and patient eligibility

About

The aim of the present work is to describe the hemodynamic effects shown in patients with ARDS secondary to SARS-CoV-2 infection

Enrollment: 67 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years old.
• Patients that are classified as a "confirmed case" according to criteria established by the Spanish Ministry of Health in its Technical Document updated on March 31, 2020. This defines a "confirmed case" as a case that meets laboratory criteria (Positive PCR test for any of the SARS-CoV-2 genes).
• Patients admitted to ICU.
• Presence of Kirby index (PaFi) less than or equal to 300 mm Hg, with PEEP or CPAP greater than or equal to 5 cmH2O.
• Need for radial artery cannulation for hemodynamic monitoring and/or repeated monitoring of blood gases at the discretion of the responsible physician.
• Patients who agree (or a representative of the patient if sedated) to participate in study and who provide written informed consent.

Exclusion criteria

• Patients being treated with veno-venous or veno-arterial ECMO
• Patient with therapeutic restrictions due to life support
• Patient who presents a complication that requires surgical intervention.

Trial design

67 participants in 1 patient group

Description Group

Description:

* For each patient included in the study, the secondary variables will be noted in the patient's data collection logbook. * This is followed by radial artery cannulation (if absent), and connection to the HemoSphere/EV1000 platform * After the daily visit, the PI/collaborating investigators (CI) will measure the clinical, treatment, and mechanical ventilation parameters of the patient during the last 24 hours. * Daily arterial analysis will be requested * This information collection process will be followed for 5 days. At the end of the information collection period, the IP will perform two downloads, the engineering download, and the standard download in which the values are monitored every 20 seconds. * These will be noted in the secondary variables of the data collection logbook, along with the patients' ICU discharge date. * In-hospital mortality will be monitored during admission to a conventional hospital ward. * Records will be closed upon discharge of the patient.