Intensive Care Unit PatientDexCapNCT04193540
Evaluation of Decision Capacity of ICU Patients Under Sedatives. A Prospective Observational Multicenter Study.
An observational study of Intensive Care Unit Patient and Mechanical Ventilation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
This prospective observational multicenter study is intended to investigate the impact of sedatives on the decision capacity of intensive care units patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Patient, Mechanical Ventilation, Sedatives
- What is being tested?
- ACE questionnaire
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2018to 15 Aug 2020
- 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: Every patient under mechanical ventilation (intubated or tracheotomized), with or without sedatives, able to communicate and alert (RASS -1 to +1), and not delirious (CAM-ICU negative) will be assessed by Johns Hopkins ACE questionnaire by a person not in charge of the patient.
Who may be able to join
- Mechanically ventilated patient (intubation or tracheotomy)
- Not delirious (negative CAM ICU)
- Calm and alert (RASS -1 to +1) since at least 12 hours and less than 72 hours
- Receiving sedatives and/or analgesics and/or medications interfering with neurological functions
- Adult patients with social security coverage
Who cannot join
- Brain injured patients (traumatic brain injury, ischemic or hemorrhagic stroke, sub-arachnoid hemorrhage, intra-parenchymal bleeding, hypoxic post cardiac arrest)
- Known cognitive disorders (MMSE < 20)
- Neurodegenerative disease
- Pregnant woman
- Protocol refusal by the patient or closest next-of-kin
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU
Clermont-Ferrand
Thomas Godet, tgodet@chu-clermontferrand.fr
About this study
This prospective observational multicenter study is intended to investigate the impact of sedatives on the decision capacity of intensive care units patients.
Read the detailed description
Medicine has recently turned from paternalism to patient-centered decisions giving them back autonomy to determine their own treatments and end-of-life directives. Main prerequisite is patient's competence to fully understand information given from medical staff, integrate it and resituate comprehensive willing.
Informed decision-making necessitates patient's ability to appropriately communicate and interact with its environment. Intensive care unit (ICU) patients are often intubated -rendering oral communication impossible- and get sedated with various medications (hypnotics and opioids). Despite an apparently appropriate communication, some of them are confused. Confusion is regularly under diagnosed in ICU settings and necessitates specific tools to be detected, such as CAM-ICU (Confusion Assessment Method in ICU). While not confused, a patient might lack decision-making capacity, meaning that despite obvious communication, more elaborated cognitive function remains uncertain and often inappropriate. Decision-making capacity can be evaluated with dedicated scores such as the Johns Hopkins adapted cognitive examination (ACE). This score has recently been formally translated into French.
The influence of sedatives on decision-making capacity remains unknown to date. This prospective observational multicentre study is intended to investigate the impact of sedatives on the decision-making capacity of ICU patients. Furthermore, each sub-score of the ACE (orientation, language, registration, attention and calculation, and recall) will be investigated according to sedatives types. Patients' decision-making capacity will be clinically assessed by physician, resident and nurse in charge, blindly of ACE result.
- Conditions
- Intensive Care Unit Patient, Mechanical Ventilation, Sedatives, Decision-making Capacity, Confusion
- Being tested
- ACE questionnaire
- Keywords
- Intensive Care Unit patient, Mechanical Ventilation, Sedatives, Decision-making capacity, Confusion
- Medical subject headings
- Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE questionnaireOther
Regardless of the result of the ACE questionnaire, physician, resident and nurse in charge of the patient will be asked their clinical opinion on decision-making capacity of the patient, based on a 4 steps Lickert scale and blindly of ACE result.
| Study group | Role | What they receive |
|---|---|---|
| ACE questionnaire | Every patient under mechanical ventilation (intubated or tracheotomized), with or without sedatives, able to communicate and alert (RASS -1 to +1), and not delirious (CAM-ICU negative) will be assessed by Johns Hopkins ACE questionnaire by a person not in charge of the patient. Receives: Other: ACE questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision-making capacity evaluated by Johns Hopkins ACE questionnaire
Global decision-making capacity is evaluated by Johns Hopkins ACE with a 3 groups classification (< 29 severe alteration, 29-55: moderate alteration; > 55 light alteration or normal cognitive function).
Measured: After inclusion
Secondary outcomes (11)
Decision-making capacity clinically evaluated by physician, resident and nurse in charge of the patient
Clinical determination of decision-making capacity of the patient blindly of Johns Hopkins ACE results
Measured: : Immediately after inclusion and prior to Johns Hopkins ACE conduct
ACE sub-items
Decision-making capacity sub-items as determined by ACE (orientation, language, registration, attention and calculation, and recall)
Measured: Immediately after inclusion
ICU length of stay
ICU length of stay
Measured: ICU discharge - Up to day 100
Hospital length of stay
Hospital length of stay
Measured: Hospital discharge - Up to day 200
Ventilatory free days
Ventilatory free days
Measured: Hospital discharge - Up to day 200
Sedatives used within 72 hours before decision-making capacity evaluation
Sedatives administered to the patient within 72 hours before Johns Hopkins ACE will be collected (midazolam, propofol, dexmedetomidine, ketamine, halogenated volatile agents)
Measured: Within 72 hours before inclusion
Analgesics used within 72 hours before decision-making capacity evaluation
Analgesics administered to the patient within 72 hours before Johns Hopkins ACE will be collected (morphine, remifentanil, sufentanyl, fentanyl)
Measured: Within 72 hours before inclusion
Other molecules used within 72 hours before decision-making capacity evaluation
Other molecules administered to the patient within 72 hours before Johns Hopkins ACE will be collected (neuroleptics, benzodiazepines, hydroxyzine, clonidine, others)
Measured: Within 72 hours before inclusion
Sedatives used during decision-making capacity evaluation
Sedatives administered to the patient during Johns Hopkins ACE will be (midazolam, propofol, dexmedetomidine, ketamine, halogenated volatile agents)
Measured: During inclusion
Analgesics used during decision-making capacity evaluation
Analgesics administered to the patient during Johns Hopkins ACE will be collected (morphine, remifentanil, sufentanyl, fentanyl
Measured: During inclusion
Other molecules used during decision-making capacity evaluation
Other molecules administered to the patient during Johns Hopkins ACE will be collected (neuroleptics, benzodiazepines, hydroxyzine, clonidine, others
Measured: During inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start15 Jul 2018
- Primary completion15 Jul 2020 (estimated)
- Study completion15 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit PatientStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Godet, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193540
- Sponsor's protocol ID
- DEXCAP
- Acronym
- DexCap
- Status last verified
- Dec 2019
- First submitted
- 5 Dec 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Decision Capacity of ICU Patients Under Sedatives. A Prospective Observational Multicenter Study.
- ClinicalTrials.gov ID
- NCT04193540
- Acronym / sponsor ID
- DexCap / DEXCAP
- Conditions
- Intensive Care Unit Patient, Mechanical Ventilation, Sedatives, Decision-making Capacity, Confusion
- Keywords
- Intensive Care Unit patient, Mechanical Ventilation, Sedatives, Decision-making capacity, Confusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 15 Jul 2020 (estimated)
- Study completion
- 15 Aug 2020 (estimated)
- First posted
- 10 Dec 2019 (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.
This prospective observational multicenter study is intended to investigate the impact of sedatives on the decision capacity of intensive care units patients.
Detailed description
Medicine has recently turned from paternalism to patient-centered decisions giving them back autonomy to determine their own treatments and end-of-life directives. Main prerequisite is patient's competence to fully understand information given from medical staff, integrate it and resituate comprehensive willing.
Informed decision-making necessitates patient's ability to appropriately communicate and interact with its environment. Intensive care unit (ICU) patients are often intubated -rendering oral communication impossible- and get sedated with various medications (hypnotics and opioids). Despite an apparently appropriate communication, some of them are confused. Confusion is regularly under diagnosed in ICU settings and necessitates specific tools to be detected, such as CAM-ICU (Confusion Assessment Method in ICU). While not confused, a patient might lack decision-making capacity, meaning that despite obvious communication, more elaborated cognitive function remains uncertain and often inappropriate. Decision-making capacity can be evaluated with dedicated scores such as the Johns Hopkins adapted cognitive examination (ACE). This score has recently been formally translated into French.
The influence of sedatives on decision-making capacity remains unknown to date. This prospective observational multicentre study is intended to investigate the impact of sedatives on the decision-making capacity of ICU patients. Furthermore, each sub-score of the ACE (orientation, language, registration, attention and calculation, and recall) will be investigated according to sedatives types. Patients' decision-making capacity will be clinically assessed by physician, resident and nurse in charge, blindly of ACE result.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACE questionnaire | – | Other: ACE questionnaireEvery patient under mechanical ventilation (intubated or tracheotomized), with or without sedatives, able to communicate and alert (RASS -1 to +1), and not delirious (CAM-ICU negative) will be assessed by Johns Hopkins ACE questionnaire by a person not in charge of the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient under mechanical ventilation (intubated or tracheotomized), with or without sedatives, able to communicate and alert (RASS -1 to +1), and not delirious (CAM-ICU negative) will be assessed by Johns Hopkins ACE questionnaire by a person not in charge of the patient.
Key inclusion criteria (5 listed)
- Mechanically ventilated patient (intubation or tracheotomy)
- Not delirious (negative CAM ICU)
- Calm and alert (RASS -1 to +1) since at least 12 hours and less than 72 hours
- Receiving sedatives and/or analgesics and/or medications interfering with neurological functions
- Adult patients with social security coverage
Key exclusion criteria (5 listed)
- Brain injured patients (traumatic brain injury, ischemic or hemorrhagic stroke, sub-arachnoid hemorrhage, intra-parenchymal bleeding, hypoxic post cardiac arrest)
- Known cognitive disorders (MMSE < 20)
- Neurodegenerative disease
- Pregnant woman
- Protocol refusal by the patient or closest next-of-kin
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 |
|---|---|---|
| ACE questionnaireRegardless of the result of the ACE questionnaire, physician, resident and nurse in charge of the patient will be asked their clinical opinion on decision-making capacity of the patient, based on a 4 steps Lickert scale and blindly of ACE result. | Other | ACE questionnaire |
Primary outcome
Decision-making capacity evaluated by Johns Hopkins ACE questionnaire
Time frame: After inclusion
Global decision-making capacity is evaluated by Johns Hopkins ACE with a 3 groups classification (< 29 severe alteration, 29-55: moderate alteration; > 55 light alteration or normal cognitive function).
11 secondary outcomes
Decision-making capacity clinically evaluated by physician, resident and nurse in charge of the patient
Time frame: : Immediately after inclusion and prior to Johns Hopkins ACE conduct
ACE sub-items
Time frame: Immediately after inclusion
ICU length of stay
Time frame: ICU discharge - Up to day 100
Hospital length of stay
Time frame: Hospital discharge - Up to day 200
Ventilatory free days
Time frame: Hospital discharge - Up to day 200
Sedatives used within 72 hours before decision-making capacity evaluation
Time frame: Within 72 hours before inclusion
Analgesics used within 72 hours before decision-making capacity evaluation
Time frame: Within 72 hours before inclusion
Other molecules used within 72 hours before decision-making capacity evaluation
Time frame: Within 72 hours before inclusion
Sedatives used during decision-making capacity evaluation
Time frame: During inclusion
Analgesics used during decision-making capacity evaluation
Time frame: During inclusion
Other molecules used during decision-making capacity evaluation
Time frame: During inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Thomas Godet principal investigator
University Hospital, Clermont-Ferrand
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 Intensive Care Unit Patient and Mechanical Ventilation, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 5 inclusion and 5 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 10 Dec 2019. 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 France. 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?
Contact Lise Laclautre (+33 4 73 754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision-making capacity evaluated by Johns Hopkins ACE questionnaire (time frame: After inclusion). 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 10 Dec 2019.