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

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 4

Conditions: Thoracic Injuries

Treatments: Drug: Dexmedetomidine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02537366

EssaiClinique-VENDETTA

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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)

Treatment:

Drug: Placebo

DEX

Experimental group

Description:

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)

Treatment:

Drug: Dexmedetomidine