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

COVID-19 Clinical Trial

Official title:

Impact and Sequelae of High Ventilatory Drive in Critically Ill COVID-19 Patients With Acute Respiratory Failure Requiring High Flow Oxygen or Mechanical Ventilation: Mechanistic and Genomic Characterization Using Artificial Intelligence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05363332
• Other study ID #: HighDrive COVID-19
• Status: Recruiting
• Start date: November 15, 2021
• Est. completion date: November 15, 2024

Study information

• Verified date: May 2022
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: November 15, 2024
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• COVID-19
• Critical Illness
• Hypoxemic Respiratory Failure
• Mechanical Ventilation Complication
• Neurocognitive Dysfunction
• Respiratory Insufficiency

Locations

Country	Name	City	State
Spain	Fundació Althaia	Manresa
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Candelaria De Haro	Sabadell	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Althaia Xarxa Assistencial Universitària de Manresa, Hospital Universitario Central de Asturias

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cluster of high respiratory drive	To describe the incidence and clustering of high respiratory drive throughout mechanical ventilation period by the development of specific algorithms.	From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days
Secondary	Artificial intelligence algorithms	To apply artificial intelligence (machine learning, deep learning, pattern/image recognition and entropy) in physiologic respiratory signals to identify potentially harmful patient-ventilator interactions.	From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days
Secondary	Neurocognitive disorders	To characterize cognitive and emotional sequelae in critically ill COVID-19 survivors at 1 month and 1 year after ICU discharge.	1 month after ICU discharge and 1 year after ICU discharge
Secondary	Gene expression	Application of massive sequencing of gene expression and circulating micro-RNA in blood samples to identify sets of genes and c-miRNA whose quantified expression is related to ventilatory asynchronies and cognitive and emotional impairment in critically ill COVID-19 patients.	day 1 of ICU admission