Critical IllnessPVI-NCOGNCT02390024
Influence of Patient/Ventilador Decoupling in Neurocognitive and Psychopathological Sequelae in ICU Patients
An observational study of Critical Illness, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Mechanical ventilation (MV) is a vital support tool for critically ill patients. However, it may present several adverse effects, such as the development of cognitive and psychopathological alterations. Patient-ventilator asynchronies occur frequently since the beginning of the MV. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Invasive Mechanical Ventilation
- Type of treatment
- Medical device
- How many people
- 156 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2015to Sep 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients undergoing mechanical ventilation and monitored with and advanced continuous monitoring system.
Who may be able to join
- Aged 18 to 80 years old.
- No neurological disease
- No evidence of COPD.
- Patients within the following 24 hours at endotracheal intubation and who are clinically expected to receive > 72 hours of mechanical ventilation
Who cannot join
- No authorization of the family or patient inclusion.
- Age outside the limits.
- Patients with prior neurological disease or focal brain damage prior to admission to the ICU
- Patients with serious psychiatric illness or mental retardation.
- Time monitoring of asynchrony < 80% of the total duration of mechanical ventilation.
- Patients who develop secondary complications (infections, stroke, brain damage or structural TC acquired) after discharge from ICU (during hospital stay) that could compromise the results of neuropsychological assessment.
- Patients with moderate to severe cognitive impairment previous to ICU stay (Short form IQCODE > 57 score)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Persistent Patient / Ventilator Decoupling in Cognitive and Psychopathological Sequelae in Critically Ill Patients: A Multicenter Clinical and Mechanisticstudy
Mechanical ventilation (MV) is a vital support tool for critically ill patients. However, it may present several adverse effects, such as the development of cognitive and psychopathological alterations. Patient-ventilator asynchronies occur frequently since the beginning of the MV. These asynchronies are associated with poor clinical outcome and could be responsible for the neuronal changes causing these alterations. The objective of this project is to analyze the influence of patient-ventilation asynchronies in the development of long-term cognitive/psychopathological impairments and to explore the molecular mechanisms that could explain of these alterations. An exploratory, observational, multicenter, non-interventionist study will be performed in 150 ICU patients. The continuous recording of asynchronies and other clinical variables during ICU stay and the results of neuropsychological assessments will enable to identify clinical clusters associated with cognitive/psychopathological impairments.
Read the detailed description
MV parameters, as well as other physiological variables, will be monitorized during the ICU stay in all patients. A neurocognitive and psychopathological assessment will be administed in all patients at 1-month and 1-year follow up.
After data collection, an asynchronies index will be calculated. A clusters analysis, based on clinical variables and asynchronies index, will be performed. The relationship between patients' clusters and the neuropsychological/ psychopathological data will be analized.
CLINICAL STUDY Univariate descriptive analysis: for quantitative variables the mean, standard deviation, percentiles 25, 50 and 75, minimum is calculated and maximum. For qualitative variables, the absolute and relative frequencies were calculated. Population interval will be estimated at 95% confidence level.
Multivariate analysis: cluster analysis, with the intention to investigate possible associations of individuals and characterization of the profile of each cluster. Comparison of standardized scores (z) of the neuropsychological variables and asynchronies index between clusters will be carried out by parametric or nonparametric techniques, as more appropriate.
Association of asynchrony with the neuropsychological variables: conditional logistic regression (case-control) of the scores of neuropsychological variables (dichotomized) versus asynchronies index will be performed, controlling for confounding covariates or factors that may have a modifier effect. The multivariate case-control matching will be performed by the method of propensity score or by genetic algorithms. The odds ratio and confidence interval of 95% was estimated.
Sample size: has been used rule of thumb for logistic regression models include between 10-15 cases per covariate. In this case, the sample will consist of 150 patients.
- Conditions
- Critical Illness
- Being tested
- Invasive Mechanical Ventilation
- Keywords
- Mechanical Ventilation, Asynchronies, Cognition
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive Mechanical VentilationDevice
Also called Asynchronies
Mechanical ventilation parameters will be monitorized during the ICU stay in all patients Four types of ventilators will be used:
Servo Dräger Evita XL Dräger Evita 4 Puritan Bennet 840
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | Mechanical Ventilation Receives: Device: Invasive Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term neurocognitive alterations
This outcome will be a composite outcome measured by:
Attention / Verbal Working Memory: Digits subtest WAIS III Attention / Visual Working Memory: Spatial Span subtest of the WMS III Verbal Learning and Memory: Auditory Verbal Learning Test Speed of Information Processing: Symbol Search subtest of WAIS III Sequencing and alternating stimuli: Trail Making Test Inhibition of the automatic reply: Stroop Test Verbal Fluency: FAS Semantic Verbal Fluency: Animals 1'
Measured: 1month after ICU discharge
Secondary outcomes (5)
Long-term neurocognitive alterations
This outcome will be a composite outcome measured by::
Attention / Verbal Working Memory: Digits subtest WAIS III Attention / Visual Working Memory: Spatial Span subtest of the WMS III Verbal Learning and Memory: Auditory Verbal Learning Test Speed of Information Processing: Symbol Search subtest of WAIS III Sequencing and alternating stimuli: Trail Making Test Inhibition of the automatic reply: Stroop Test Verbal Fluency: FAS Semantic Verbal Fluency: Animals 1'
Measured: 1year after ICU discharge
Short-term anxiety and depression symptoms
Measured by::
Hospital Anxiety and Depression Scale (HADS)
Measured: 1month after ICU discharge
Short-term Post-traumatic Stress Disorder
Measured by:
Post Traumatic Stress Syndrome: Davidson Trauma Scale
Measured: 1month after ICU discharge
Long-term anxiety and depression symptoms
Measured by:
Hospital Anxiety and Depression Scale (HADS)
Measured: 1year after ICU discharge
Long-term Post-traumatic Stress Disorder
Measured by:
Post Traumatic Stress Syndrome: Davidson Trauma Scale
Measured: 1year after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Althaia Xarxa Assistencial Universitària de Manresa, Hospital Mutua de Terrassa
- Responsible party
- Principal investigator, Lluis Blanch, Corporacion Parc Tauli
- Investigators
- Lluís Blanch Torra, PhD, Principal investigator, Fundació Parc Taulí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390024
- Sponsor's protocol ID
- PI13/02204
- Acronym
- PVI-NCOG
- Status last verified
- Mar 2020
- First submitted
- 27 Feb 2015
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fernandez-Gonzalo S, Navarra-Ventura G, Bacardit N, Goma Fernandez G, de Haro C, Subira C, Lopez-Aguilar J, Magrans R, Sarlabous L, Aquino Esperanza J, Jodar M, Rue M, Ochagavia A, Palao DJ, Fernandez R, Blanch L. Cognitive phenotypes 1 month after ICU discharge in mechanically ventilated patients: a prospective observational cohort study. Crit Care. 2020 Oct 21;24(1):618. doi: 10.1186/s13054-020-03334-2.
PubMed 33087171
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Persistent Patient / Ventilator Decoupling in Cognitive and Psychopathological Sequelae in Critically Ill Patients: A Multicenter Clinical and Mechanisticstudy
- ClinicalTrials.gov ID
- NCT02390024
- Acronym / sponsor ID
- PVI-NCOG / PI13/02204
- Conditions
- Critical Illness
- Keywords
- Mechanical Ventilation, Asynchronies, Cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Althaia Xarxa Assistencial Universitària de Manresa, Hospital Mutua de Terrassa
- Study start
- Jun 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 17 Mar 2015 (estimated)
- 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.
Mechanical ventilation (MV) is a vital support tool for critically ill patients. However, it may present several adverse effects, such as the development of cognitive and psychopathological alterations. Patient-ventilator asynchronies occur frequently since the beginning of the MV. These asynchronies are associated with poor clinical outcome and could be responsible for the neuronal changes causing these alterations. The objective of this project is to analyze the influence of patient-ventilation asynchronies in the development of long-term cognitive/psychopathological impairments and to explore the molecular mechanisms that could explain of these alterations. An exploratory, observational, multicenter, non-interventionist study will be performed in 150 ICU patients. The continuous recording of asynchronies and other clinical variables during ICU stay and the results of neuropsychological assessments will enable to identify clinical clusters associated with cognitive/psychopathological impairments.
Detailed description
MV parameters, as well as other physiological variables, will be monitorized during the ICU stay in all patients. A neurocognitive and psychopathological assessment will be administed in all patients at 1-month and 1-year follow up.
After data collection, an asynchronies index will be calculated. A clusters analysis, based on clinical variables and asynchronies index, will be performed. The relationship between patients' clusters and the neuropsychological/ psychopathological data will be analized.
CLINICAL STUDY Univariate descriptive analysis: for quantitative variables the mean, standard deviation, percentiles 25, 50 and 75, minimum is calculated and maximum. For qualitative variables, the absolute and relative frequencies were calculated. Population interval will be estimated at 95% confidence level.
Multivariate analysis: cluster analysis, with the intention to investigate possible associations of individuals and characterization of the profile of each cluster. Comparison of standardized scores (z) of the neuropsychological variables and asynchronies index between clusters will be carried out by parametric or nonparametric techniques, as more appropriate.
Association of asynchrony with the neuropsychological variables: conditional logistic regression (case-control) of the scores of neuropsychological variables (dichotomized) versus asynchronies index will be performed, controlling for confounding covariates or factors that may have a modifier effect. The multivariate case-control matching will be performed by the method of propensity score or by genetic algorithms. The odds ratio and confidence interval of 95% was estimated.
Sample size: has been used rule of thumb for logistic regression models include between 10-15 cases per covariate. In this case, the sample will consist of 150 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | Device: Invasive Mechanical VentilationMechanical Ventilation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients undergoing mechanical ventilation and monitored with and advanced continuous monitoring system.
Key inclusion criteria (4 listed)
- Aged 18 to 80 years old.
- No neurological disease
- No evidence of COPD.
- Patients within the following 24 hours at endotracheal intubation and who are clinically expected to receive > 72 hours of mechanical ventilation
Key exclusion criteria (7 listed)
- No authorization of the family or patient inclusion.
- Age outside the limits.
- Patients with prior neurological disease or focal brain damage prior to admission to the ICU
- Patients with serious psychiatric illness or mental retardation.
- Time monitoring of asynchrony < 80% of the total duration of mechanical ventilation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive Mechanical VentilationAlso: AsynchroniesMechanical ventilation parameters will be monitorized during the ICU stay in all patients Four types of ventilators will be used: Servo Dräger Evita XL Dräger Evita 4 Puritan Bennet 840 | Device | Critically ill patients |
Primary outcome
Short-term neurocognitive alterations
Time frame: 1month after ICU discharge
This outcome will be a composite outcome measured by: Attention / Verbal Working Memory: Digits subtest WAIS III Attention / Visual Working Memory: Spatial Span subtest of the WMS III Verbal Learning and Memory: Auditory Verbal Learning Test Speed of Information Processing: Symbol Search subtest of WAIS III Sequencing and alternating stimuli: Trail Making Test Inhibition of the automatic reply: Stroop Test Verbal Fluency: FAS Semantic Verbal Fluency: Animals 1'
5 secondary outcomes
Long-term neurocognitive alterations
Time frame: 1year after ICU discharge
Short-term anxiety and depression symptoms
Time frame: 1month after ICU discharge
Short-term Post-traumatic Stress Disorder
Time frame: 1month after ICU discharge
Long-term anxiety and depression symptoms
Time frame: 1year after ICU discharge
Long-term Post-traumatic Stress Disorder
Time frame: 1year after ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Derived from this study: PubMed 33087171Fernandez-Gonzalo S, Navarra-Ventura G, Bacardit N, Goma Fernandez G, de Haro C, Subira C, Lopez-Aguilar J, Magrans R, Sarlabous L, Aquino Esperanza J, Jodar M, Rue M, Ochagavia A, Palao DJ, Fernandez R, Blanch L. Cognitive phenotypes 1 month after ICU discharge in mechanically ventilated patients: a prospective observational cohort study. Crit Care. 2020 Oct 21;24(1):618. doi: 10.1186/s13054-020-03334-2.
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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.
Lluís Blanch Torra, PhD principal investigator
Fundació Parc Taulí
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Corporacion Parc Tauli at 1 site 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term neurocognitive alterations (time frame: 1month after ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02390024, which also lists 1 linked publication.
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 12 Mar 2020.