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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03043092
Other study ID # IRB 14/05-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 14, 2016
Est. completion date September 19, 2018

Study information

Verified date January 2019
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Transcranial Doppler ultrasound is bedside tool use to assess cerebral blood perfusion in critically ill patients. We sought to conduct a prospective, single centre study aiming to determine whether chronic vascular diseases may be a confounder in transcranial Doppler ultrasound assessment in critically ill patients.


Description:

Intracranial hypertension is associated with altered transcranial doppler parameters measured in the middle cerebral artery such as decreasing diastolic velocity and increasing pulsatility index with higher intracranial pressure (ICP). Chronic vascular diseases in modifying arterial resistance may interfere with transcranial Doppler ultrasound assessment mimicking intracranial hypertension profile.

The aim of this prospective, single centre study enrolling critically ill patients without any acute neurological disease is to to determine the pattern of transcranial Doppler ultrasound variables amongst patients with and without chronic vascular diseases.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date September 19, 2018
Est. primary completion date September 19, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patient intubated, ventilated, adaptated on ventilator

- affiliated to healthcare insurance

- patient available for 24h follow up

- patient >18 years

Exclusion Criteria:

- admitted in ICU for cerebral aggression (<3 month): stroke, trauma brain injury, meningitis

- carotid surgery <1 month

- patient refuse to consent

- legal guardianship

- pregnancy

- mean blood pressure <65mmHg or >100mmHg

- non echogenic patient

- hypoglycemia <0.6g/l

- pH<7.30

- T°<35°C

- Patient already included in this study

Study Design


Locations

Country Name City State
France Nimes University hospital Nimes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Transcranial Doppler ultrasound assessment of pulsatility index in middle cerebral arteries first twenty four hours of ICU admission
Primary Transcranial Doppler ultrasound assessment of diastolic velocity in middle cerebral arteries first twenty four hours of ICU admission
Primary Transcranial Doppler ultrasound assessment of mean velocity in middle cerebral arteries first twenty four hours of ICU admission
Secondary Transcranial Doppler ultrasound assessment of systolic velocity in middle cerebral arteries first twenty four hours of ICU admission
Secondary Transcranial Doppler ultrasound assessment of resistive index in middle cerebral arteries first twenty four hours of ICU admission
Secondary Carotid Doppler ultrasound assessment of systolic, mean and diastolic velocity ten days of ICU admission
Secondary Pulse wave velocity ten days of ICU admission
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