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

NCT05363332 | Unknown

• 1 other identifier: HighDrive COVID-19
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Respiratory drive

  To characterize the high respiratory drive phenomena in critically ill COVID-19 patients undergoing mechanical ventilation.

  From day 1 at ICU until the day were the criteria of PaFi > 300 is met, up to 30 days

Secondary Outcomes (4)

• Cluster of high respiratory drive

  From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days

• Artificial intelligence algorithms

  From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days

• Neurocognitive disorders

  1 month after ICU discharge and 1 year after ICU discharge

• Gene expression

  day 1 of ICU admission

Study Arms (2)

COVID-19 Cohort

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

Non COVID-19 Cohort

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

Eligibility Criteria

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

Study Population

Adult patients admitted to ICU with acure respiratory failure secondary to COVID-19 infection and other etiologies.

You may qualify if:

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

You may not qualify if:

• Neurologic patients with brainsteam affection.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Althaia Xarxa Assistencial Universitària de Manresa: collaborator
• Hospital Universitario Central de Asturias: collaborator

Study Sites (3)

Candelaria De Haro

Sabadell, Barcelona, 08208, Spain

RECRUITING

Fundació Althaia

Manresa, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Spain

RECRUITING

MeSH Terms

Conditions

COVID-19; Critical Illness; Respiratory Insufficiency; Cognition Disorders

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; Respiration Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor and Doctor of Philosophy

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 5, 2022
• Study Start: November 15, 2021
• Primary Completion: May 15, 2023
• Study Completion: November 15, 2024
• Last Updated: May 5, 2022

Record last verified: 2022-05

Locations

ES (3)