COVID-19NCT05363332
Impact and Sequelae of High Ventilatory Drive in Critically Ill COVID-19 Patients
An observational study of COVID-19 and Critical Illness, run by Corporacion Parc Tauli at 3 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Critical Illness, Hypoxemic Respiratory Failure
- How many people
- 126 participants
- Where
- 3 sitesSpain
- Study dates
- 15 Nov 2021to 15 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to ICU with acure respiratory failure secondary to COVID-19 infection and other etiologies.
Who may be able to join
- Adults patients with hypoxemic respiratory failure.
- Admitted to ICU.
- Mechanical ventilation or high flow nasal cannula
Who cannot join
- Neurologic patients with brainsteam affection.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Fundació Althaia
Manresa
Rafael Fernandez, PhD, 938 75 93 00, rfernandez@althaia.cat
Montserrat Batlle, MD, PhD
- Recruiting
Hospital Universitario Central de Asturias
Oviedo
Guilermo Muñiz-Albaiceta, PhD, 985 10 80 00, gma@cri-lab.org
- Recruiting
Candelaria De Haro
Sabadell, Barcelona, 08208
Candelaria De Haro, MD, PhD, 0034937231010 ext. 21158, cdeharo@tauli.cat
Josefina Lopez-Aguilar, PhD
About this study
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
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.
- Conditions
- COVID-19, Critical Illness, Hypoxemic Respiratory Failure, Neurocognitive Dysfunction, Mechanical Ventilation Complication
- Medical subject headings
- COVID-19, Critical Illness, Respiratory Insufficiency, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory drive
To characterize the high respiratory drive phenomena in critically ill COVID-19 patients undergoing mechanical ventilation.
Measured: From day 1 at ICU until the day were the criteria of PaFi > 300 is met, up to 30 days
Secondary outcomes (4)
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.
Measured: From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days
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.
Measured: From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days
Neurocognitive disorders
To characterize cognitive and emotional sequelae in critically ill COVID-19 survivors at 1 month and 1 year after ICU discharge.
Measured: 1 month after ICU discharge and 1 year after ICU discharge
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.
Measured: day 1 of ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start15 Nov 2021
- Primary completion15 May 2023 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Althaia Xarxa Assistencial Universitària de Manresa, Hospital Universitario Central de Asturias
- Responsible party
- Principal investigator, Candelaria de Haro, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363332
- Sponsor's protocol ID
- HighDrive COVID-19
- Status last verified
- May 2022
- First submitted
- 29 Apr 2022
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05363332
- Acronym / sponsor ID
- HighDrive COVID-19
- Conditions
- COVID-19, Critical Illness, Hypoxemic Respiratory Failure, Neurocognitive Dysfunction, Mechanical Ventilation Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Althaia Xarxa Assistencial Universitària de Manresa, Hospital Universitario Central de Asturias
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to ICU with acure respiratory failure secondary to COVID-19 infection and other etiologies.
Key inclusion criteria (3 listed)
- Adults patients with hypoxemic respiratory failure.
- Admitted to ICU.
- Mechanical ventilation or high flow nasal cannula
Key exclusion criteria (1 listed)
- Neurologic patients with brainsteam affection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory drive
Time frame: 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.
4 secondary outcomes
Cluster of high respiratory drive
Time frame: From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days
Artificial intelligence algorithms
Time frame: From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days
Neurocognitive disorders
Time frame: 1 month after ICU discharge and 1 year after ICU discharge
Gene expression
Time frame: day 1 of ICU admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Critical Illness, run by Corporacion Parc Tauli at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory drive (time frame: From day 1 at ICU until the day were the criteria of PaFi > 300 is met, up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.