Influence of Chronic Vascular Diseases on Transcranial Doppler Profiles in Critically Ill Patients (CritiDop)

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 Overview

• Status: Completed
• Conditions: Respiration, Artificial; Sedated

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All sedated patients under mechanical respiratory assistance will be included. These are further devided into 2 groups.

Description

Inclusion Criteria for entry in the study:

• 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
• 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

Inclusion criteria for entry in group 2:

• The included patient is not in group 1

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pulsatility index on the middle cerebral arteries	Day 0
Diastolic velocity at the middle cerebral arteries	Day 0
Mean velocity at the middle cerebral arteries	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Laurent Muller, MD, PhD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2016
• Primary Completion (Actual): September 14, 2018
• Study Completion (Actual): September 14, 2018

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: LOCAL/2015/LM-01b