Respiration, ArtificialCritiDopNCT02898389
Influence of Chronic Vascular Diseases on Transcranial Doppler Profiles in Critically Ill Patients
An observational study of Respiration, Artificial and Sedated, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The primary objective of this study is to show that cardiovascular risk factors associated with the chronic elevation of arterial resistance may be associated with "false" profiles of intracranial hypertension during transcranial doppler ultrasound of the middle cerebral arteries in intensive care unit patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration, Artificial, Sedated
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2016to 14 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All sedated patients under mechanical respiratory assistance will be included. These are further devided into 2 groups.
Who may be able to join
- Sedated patient under mechanical respiratory assistance
- Inclusion criteria for entry in group 1: the patient meets at least one of the following criteria:
- The patient is a man over the age of 50 or a woman over the age of 60
- Hypercholesterolemia (LDL > 1.6 g/L, HDL < 0.4 g/L)
- Arterial hypertension for over 10 years (treated or systolic arterial pressure > 140 mmHG)
- Type 2 diabetes for over 10 years
Show all 10Show fewer
- Active or former smoker in the past 3 years
- History of cardiovascular event (peripheral artery disease, heart attack, stroke/transient ischemic attack over 3 months ago)
- Chronic renal insufficiency with MDRD < 30 ml/min/1.73m^2
- The included patient is not in group 1
Who cannot join
- acute neurological disorder (brain trauma, infectious or immune meningitis, meningoencephalitis, ischemic or hemorrhagic stroke <3 months)
- pregnant woman
- person under guardianship
- prisoners
- recent carotid surgery (<1 month)
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to show that cardiovascular risk factors associated with the chronic elevation of arterial resistance may be associated with "false" profiles of intracranial hypertension during transcranial doppler ultrasound of the middle cerebral arteries in intensive care unit patients. A "false" profile of intracranial hypertension is defined by a high pulsatility index without any intracranial pathology.
- Conditions
- Respiration, Artificial, Sedated
- Medical subject headings
- Respiratory Aspiration
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 |
|---|---|---|
| Group 1: With cardiovascular risk factors | Patients fall within this group when they have at least one of the cardiovascular risk factors listed in the eligibility criteria section. | |
| Group 1: Without cardiovascular risk factors | Patients fall into this group when they do not have any of the cardiovascular risk factors listed in the eligibility criteria section. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulsatility index on the middle cerebral arteries
Measured: Day 0
Diastolic velocity at the middle cerebral arteries
Measured: Day 0
Mean velocity at the middle cerebral arteries
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start14 Jun 2016
- Primary completion14 Sep 2018
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration, ArtificialStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Muller, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898389
- Sponsor's protocol ID
- LOCAL/2015/LM-01b
- Acronym
- CritiDop
- Status last verified
- Aug 2020
- First submitted
- 8 Sep 2016
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Chronic Vascular Diseases on Transcranial Doppler Profiles in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02898389
- Acronym / sponsor ID
- CritiDop / LOCAL/2015/LM-01b
- Conditions
- Respiration, Artificial, Sedated
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 13 Sep 2016 (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.
The primary objective of this study is to show that cardiovascular risk factors associated with the chronic elevation of arterial resistance may be associated with "false" profiles of intracranial hypertension during transcranial doppler ultrasound of the middle cerebral arteries in intensive care unit patients. A "false" profile of intracranial hypertension is defined by a high pulsatility index without any intracranial pathology.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: With cardiovascular risk factors | – | –Patients fall within this group when they have at least one of the cardiovascular risk factors listed in the eligibility criteria section. |
| Group 1: Without cardiovascular risk factors | – | –Patients fall into this group when they do not have any of the cardiovascular risk factors listed in the eligibility criteria section. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All sedated patients under mechanical respiratory assistance will be included. These are further devided into 2 groups.
Key inclusion criteria (10 listed)
- Sedated patient under mechanical respiratory assistance
- Inclusion criteria for entry in group 1: the patient meets at least one of the following criteria:
- The patient is a man over the age of 50 or a woman over the age of 60
- Hypercholesterolemia (LDL > 1.6 g/L, HDL < 0.4 g/L)
- Arterial hypertension for over 10 years (treated or systolic arterial pressure > 140 mmHG)
Key exclusion criteria (5 listed)
- acute neurological disorder (brain trauma, infectious or immune meningitis, meningoencephalitis, ischemic or hemorrhagic stroke <3 months)
- pregnant woman
- person under guardianship
- prisoners
- recent carotid surgery (<1 month)
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
Pulsatility index on the middle cerebral arteries
Time frame: Day 0
Diastolic velocity at the middle cerebral arteries
Time frame: Day 0
Mean velocity at the middle cerebral arteries
Time frame: Day 0
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 Aug 2020.
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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.
Laurent Muller, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
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 Respiration, Artificial and Sedated, run by Centre Hospitalier Universitaire de Nīmes 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 10 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: finished, as of the sponsor's last update on 12 Aug 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 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?
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?
Pulsatility index on the middle cerebral arteries (time frame: Day 0). The study lists 3 primary outcomes in all. 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 12 Aug 2020.