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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05363332
Other study ID # HighDrive COVID-19
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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