Impact and Sequelae of High Ventilatory Drive in Critically Ill COVID-19 Patients

NCT ID: NCT05363332

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 126 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2024-11-15

Brief Summary

Critically ill COVID-19 patients with acute respiratory failure, in the intensive care unit (ICU), often feature high respiratory drive, determining large inspiratory efforts resulting in high pressures and global and regional over-distention, leading to lung injury. SARS-CoV-2 neurotropic-penetration in control centers in medulla oblongata might contribute to dysregulation and to excessively high respiratory drive observed in these patients. These pathophysiological conditions may often lead to the development of patient-ventilator asynchronies in aptients under mechanical ventilation, again leading to high tidal volumes and increased lung injury. These phenomena can contribute to prolonged duration of mechanical ventilation and ICU length of stay, but also can result in long term adverse outcomes like emotional/psychological and cognitive sequelae. All them compromising the quality of life of critically ill survivors after ICU discharge.

The investigators will conduct a multicenter study in adult critically ill COVID-19 patients with hypoxemic respiratory failure, aiming to: 1) characterize incidence and clustering of high respiratory drive by developing algorithms, 2) apply artificial intelligence in respiratory signals to identify potentially harmful patient-ventilator interactions, 3) characterize cognitive and emotional sequelae in critically ill COVID-19 survivors after ICU discharge and 4) identify sets of genes and transcriptomic signatures whose quantified expression predisposed to asynchronies and cognitive impairment in critically ill COVID-19 patients.

Conditions

COVID-19; Critical Illness; Hypoxemic Respiratory Failure; Neurocognitive Dysfunction; Mechanical Ventilation Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COVID-19 Cohort

Patients with a diagnosis of moderate or severe pneumonia or ARDS secondary to COVID-19.

No interventions assigned to this group

Non COVID-19 Cohort

Patients with a diagnosis of moderate or severe pneumonia or ARDS not secondary to COVID-19.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Adults patients with hypoxemic respiratory failure.
• Admitted to ICU.
• Mechanical ventilation or high flow nasal cannula

Exclusion Criteria

• Neurologic patients with brainsteam affection.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Althaia Xarxa Assistencial Universitària de Manresa

OTHER

Sponsor Role: collaborator

Hospital Universitario Central de Asturias

OTHER

Sponsor Role: collaborator

Corporacion Parc Tauli

OTHER

Sponsor Role: lead

Responsible Party

Candelaria de Haro

Medical doctor and Doctor of Philosophy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Candelaria De Haro

Sabadell, Barcelona, Spain

Site Status: RECRUITING

Fundació Althaia

Manresa, , Spain

Site Status: RECRUITING

Hospital Universitario Central de Asturias

Oviedo, , Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Candelaria De Haro, MD, PhD

Role: primary

cdeharo@tauli.cat

0034937231010 ext. 21158

Rafael Fernandez, PhD

Role: primary

rfernandez@althaia.cat

938 75 93 00

Guilermo Muñiz-Albaiceta, PhD

Role: primary

gma@cri-lab.org

985 10 80 00

Other Identifiers

HighDrive COVID-19

Identifier Type: -

Identifier Source: org_study_id