Myocardial Dysfunction at Early Phase of Traumatic Brain Injury : Evaluation by Two Dimensional and Speckle Tracking Transthoracic Echocardiography

Not Applicable

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Other: Transthoracic echocardiography on TBI patients; Other: Transthoracic echocardiography on control patients

• Registration Number: NCT02380482
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

Traumatic brain injury (TBI) is a frequent pathology leading to major morbidity and mortality in young people. Cerebral flood flow maintenance is a major goal directed therapy to improve the prognosis of the patient. Due to cerebral-myocardial interaction, a myocardial dysfunction might occur at the early phase of the traumatic brain injury. This myocardial dysfunction could be partly responsible for a decrease in cerebral blood flow. In such case, improving myocardial dysfunction may help to increase cerebral blood flow and improve patient prognosis. In clinical practice the easiest and non invasive way to explore myocardial dysfunction is with transthoracic echocardiography. The objective of this trial is to investigate myocardial dysfunction at the early phase of traumatic brain injury, compared with a controlled group without TBI.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-02-27
• Study First Posted: 2015-03-05
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Isolated and non opened traumatic brain injury
• 18 - 65 years old
• Intubated and mechanically ventilated
• Glasgow score < or = 9 or
• Glasgow score between 9 and 13 (included) and Following Traumatic Coma Data Bank Tomographic Damages diffuse injuries type III or IV or mass lesion over 25ml and/or neurosurgical injuries
• Medical insurance

Exclusion Criteria

• Treated major cardiovascular risks factors
• cardiovascular past medical history (acute cardiovascular event)
• Cardio thoracic surgery
• Brain dead status
• Inotrope drugs
• Severe polytraumatism
• Acute haemorrhage
• Non echogenic patient
• High level athlete
• Incapacitated person by law and pregnant women
• Discovery during echocardiography of underlying cardiomyopathy
• Urgent neurosurgery required

Control patients

Inclusion Criteria:

• Isolated and non opened traumatic brain injury
• 18 - 65 years old
• Intubated and mechanically ventilated
• Paired with TBI patient on age, BMI and sex
• Undergoing urgent non severe surgery
• Medical insurance

Exclusion Criteria:

• Traumatic brain injury
• Treated major cardiovascular risks factors
• cardiovascular past medical history (acute cardiovascular event)
• Cardio thoracic surgery
• Inotrope and vasopressive drugs
• Circulatory failure
• Non echogenic patient
• High level athlete
• Incapacitated person by law and pregnant women
• Discovery during echocardiography of underlying cardiomyopathy
• Urgent neurosurgery required

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traumatic brain injury	Transthoracic echocardiography on TBI patients	Two dimensional and speckle tracking transthoracic echocardiography in traumatic brain injured patients * Glasgow score \< or = 9 or * Glasgow score between 9 and 13 (included) and Following Traumatic Coma Data Bank Tomographic Damages: diffuse injuries type III or IV or mass lesion over 25ml and/or neurosurgical injuries
Controls	Transthoracic echocardiography on control patients	Two dimensional and speckle tracking transthoracic echocardiography in control patients paired with traumatic brain injured patient on age, BMI and sex with the following criteria: * Intubated and mechanically ventilated * Undergoing urgent non severe surgery

Primary Outcome Measures

Name	Time	Method
left ventricular ejection fraction	within the first 24 hours after injury

Secondary Outcome Measures

Name	Time	Method
Systolic strain rate by speckle tracking (in second)	within the first 24 hours after injury
Diastolic strain rate by speckle tracking (in second)	within the first 24 hours after injury
Systolic rotational velocity by speckle tracking (in degree by second)	within the first 24 hours after injury
Diastolic rotational velocity by speckle tracking (in degree by second)	within the first 24 hours after injury
Systolic twisting velocity by speckle tracking (in degree by second)	within the first 24 hours after injury
Diastolic untwisting velocity by speckle tracking (in degree by second)	within the first 24 hours after injury
Myocardial wall thickness (in millimeter)	within the first 24 hours after injury	2D transthoracic echography
left ventricular diastolic function (cm/sec)	within the first 24 hours after injury	2D transthoracic echography
Cardiac index	within the first 24 hours after injury	2D transthoracic echography
tissue doppler imaging (cm/sec)	within the first 24 hours after injury	2D transthoracic echography
right ventricular diastolic function	within the first 24 hours after injury	2D transthoracic echography
right ventricular systolic function	within the first 24 hours after injury	2D transthoracic echography
Strain evaluation by speckle tracking (in percentage of systolic duration)	within the first 24 hours after injury

Trial Locations

Locations (1)

University hospital; 🇫🇷 Grenoble, France