Dexmedetomidine for Non-invasive Ventilation After Chest Trauma

Study Overview
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Brief Summary
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Crossover randomized controlled double blinded trial : The primary endpoint is the duration of Non Invasive Ventilation (NIV) session (minutes) with dexmedetomidine (DEX) or placebo. Secondary endpoints will be the sedation level as assessed by the Richmond Agitation Sedation Scale (RASS), the number of interventions to allow the completion of NIV session, the pain intensity level as assessed by visual analogue scale, the morphine and ketamine consumption during NIV sessions, the comparison of blood gas measurements before and after NIV sessions, the reproducibility of NIV cycles. The side effects of DEX will be notified.

Official Title
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Dexmedetomidine for Non-invasive Ventilation After Chest Trauma (VENDETTA)

Conditions
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Thoracic Injuries

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Blunt chest trauma with thoracic trauma score> 6, ICU admission and spontaneous breathing Exclusion Criteria: Contra indication for NIV or Dexmedetomidine as specified by the French marketing authorization

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Sodium Chloride 0,9 % Continuous IV infusion begun one hour before NIV session at 0.07 ml/kg/h Adaptation to sedation status by changing infusion speed of 0.02 ml/kg/h every 30 minutes up to 0.14 ml/kg/h Sedation objective Richmond Agitation Sedation Scale -3 (moderate sedation) to 0 (alert and calm) | Drug: Placebo<br> <br> |
| Experimental: DEX<br>Dexmedetomidine diluted to 10 µg/ml in Sodium Chloride 0,9 % Continuous IV infusion begun one hour before NIV session at 0.7 µg/kg/h (= 0.07 ml/kg/h) Adaptation to sedation status by changing infusion speed of 0.2 µg/kg/h (= 0.02 ml/kg/h) every 30 minutes up to 1.4 µg/kg/h (= 0.14 ml/kg/h) Sedation objective Richmond Agitation Sedation Scale -3 (moderate sedation) to 0 (alert and calm) | Drug: Dexmedetomidine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of NIV session | Minutes | During ICU stay (expected average of 2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Richmond Agitation-Sedation Scale | From -5 (Unarousable) to +4 (Combative) | During ICU stay (expected average of 2 weeks) | 
| Number of interventions on NIV settings |  | During ICU stay (expected average of 2 weeks) | 
| Morphine consumption | Morphine administration during NIV session (mg/kg/h) | During ICU stay (expected average of 2 weeks) | 
| Ketamine consumption | Ketamine administration during NIV session (mg/kg/h) | During ICU stay (expected average of 2 weeks) | 
| Pain visual analogue scale | From 0 (no pain) to 10 (worst pain possible) | During ICU stay (expected average of 2 weeks) | 
| Variation of arterial partial pressure of Carbon dioxide (CO2) before and after NIV session | mmHg | During ICU stay (expected average of 2 weeks) | 
| Variation of arterial partial pressure of dioxygen (O2) before and after NIV session | mmHg | During ICU stay (expected average of 2 weeks) | 
| Variation of potential hydrogen (pH) before and after NIV session |  | During ICU stay (expected average of 2 weeks) | 
| Reproductibility of NIV sessions | Minutes | During ICU stay (expected average of 2 weeks) | 
| Bradycardia | Mean arterial pressure less than 55 mmHg | During ICU stay (expected average of 2 weeks) | 
| Hypotension | Heart rate less than 40 / mn | During ICU stay (expected average of 2 weeks) |