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

Recruiting

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

• Registration Number: NCT05363332
• Lead Sponsor: Corporacion Parc Tauli

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-15
• Study First Submitted: 2022-04-29
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-03
• Last Update Submitted: 2022-05-03
• Study First Posted: 2022-05-05
• Last Update Posted: 2022-05-05
• Primary Completion: 2023-05-15
• Study Completion: 2024-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiratory drive	From day 1 at ICU until the day were the criteria of PaFi > 300 is met, up to 30 days	To characterize the high respiratory drive phenomena in critically ill COVID-19 patients undergoing mechanical ventilation.

Secondary Outcome Measures

Name	Time	Method
Cluster of high respiratory drive	From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days	To describe the incidence and clustering of high respiratory drive throughout mechanical ventilation period by the development of specific algorithms.
Artificial intelligence algorithms	From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days	To apply artificial intelligence (machine learning, deep learning, pattern/image recognition and entropy) in physiologic respiratory signals to identify potentially harmful patient-ventilator interactions.
Neurocognitive disorders	1 month after ICU discharge and 1 year after ICU discharge	To characterize cognitive and emotional sequelae in critically ill COVID-19 survivors at 1 month and 1 year after ICU discharge.
Gene expression	day 1 of ICU admission	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.

Trial Locations

Locations (3)

Candelaria De Haro; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Spain

Fundació Althaia; 🇪🇸 Manresa, Spain