Dexmedetomidine for Non-invasive Ventilation After Chest Trauma

Phase 4

Completed

• Conditions: Thoracic Injuries
• Interventions: Drug: Placebo; Drug: Dexmedetomidine

• Registration Number: NCT02537366
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-08-21
• Study First Submitted QC: 2015-08-31
• Study Start: 2015-09
• Study First Posted: 2015-09-01
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-08
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Blunt chest trauma with thoracic trauma score> 6, ICU admission and spontaneous breathing

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Exclusion Criteria

• Contra indication for NIV or Dexmedetomidine as specified by the French marketing authorization

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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)
DEX	Dexmedetomidine	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)

Primary Outcome Measures

Name	Time	Method
Duration of NIV session	During ICU stay (expected average of 2 weeks)	Minutes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Grenoble; 🇫🇷 Grenoble, France