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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05363332
Enrollment
126
Registered
2022-05-05
Start date
2021-11-15
Completion date
2024-11-15
Last updated
2022-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Althaia Xarxa Assistencial Universitària de Manresa
CollaboratorOTHER
Hospital Universitario Central de Asturias
CollaboratorOTHER
Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Respiratory driveFrom day 1 at ICU until the day were the criteria of PaFi > 300 is met, up to 30 daysTo characterize the high respiratory drive phenomena in critically ill COVID-19 patients undergoing mechanical ventilation.

Secondary

MeasureTime frameDescription
Cluster of high respiratory driveFrom day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 daysTo describe the incidence and clustering of high respiratory drive throughout mechanical ventilation period by the development of specific algorithms.
Artificial intelligence algorithmsFrom day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 daysTo apply artificial intelligence (machine learning, deep learning, pattern/image recognition and entropy) in physiologic respiratory signals to identify potentially harmful patient-ventilator interactions.
Neurocognitive disorders1 month after ICU discharge and 1 year after ICU dischargeTo characterize cognitive and emotional sequelae in critically ill COVID-19 survivors at 1 month and 1 year after ICU discharge.
Gene expressionday 1 of ICU admissionApplication 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026