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

Sponsor

Corporacion Parc Tauli (Other)

Overall Status

Recruiting

CT.gov ID

NCT05363332

Collaborator

Althaia Xarxa Assistencial Universitària de Manresa (Other), Hospital Universitario Central de Asturias (Other)

126

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Critical Illness Hypoxemic Respiratory Failure Neurocognitive Dysfunction Mechanical Ventilation Complication

Study Design

Study Type:

Observational

Anticipated Enrollment :

126 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Nov 15, 2021

Anticipated Primary Completion Date :

May 15, 2023

Anticipated Study Completion Date :

Nov 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
COVID-19 Cohort Patients with a diagnosis of moderate or severe pneumonia or ARDS secondary to COVID-19.
Non COVID-19 Cohort Patients with a diagnosis of moderate or severe pneumonia or ARDS not secondary to COVID-19.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Candelaria De Haro	Sabadell	Barcelona	Spain	08208
2	Fundació Althaia	Manresa		Spain
3	Hospital Universitario Central de Asturias	Oviedo		Spain

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Candelaria de Haro, Medical doctor and Doctor of Philosophy, Corporacion Parc Tauli

ClinicalTrials.gov Identifier:

NCT05363332

Other Study ID Numbers:

HighDrive COVID-19

First Posted:

May 5, 2022

Last Update Posted:

May 5, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Respiratory Insufficiency

Critical Illness

Cognitive Dysfunction

Study Results

No Results Posted as of May 5, 2022