Clinical trial NCT05363332: Impact and Sequelae of High Ventilatory Drive in Critically Ill COVID-19 Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Critical Illness
Hypoxemic Respiratory Failure
Neurocognitive Dysfunction
Mechanical Ventilation Complication
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Althaia Xarxa Assistencial Universitària de Manresa
name: Hospital Universitario Central de Asturias
First posted: 2022-05-05
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to ICU with acure respiratory failure secondary to COVID-19 infection and other etiologies.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Respiratory drive
timeFrame: From day 1 at ICU until the day were the criteria of PaFi > 300 is met, up to 30 days
Secondary outcomes:
measure: Cluster of high respiratory drive
timeFrame: From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days
measure: Artificial intelligence algorithms
timeFrame: From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days
measure: Neurocognitive disorders
timeFrame: 1 month after ICU discharge and 1 year after ICU discharge
measure: Gene expression
timeFrame: day 1 of ICU admission
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Candelaria De Haro
state: Barcelona
city: Manresa
country: Spain
facility: Fundació Althaia
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
Study officials:
References: