Thoracic Injuries
Conditions
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.
Interventions
DRUGDexmedetomidine
DRUGPlacebo
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of NIV session | During ICU stay (expected average of 2 weeks) | Minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| 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) | — |
| Pain visual analogue scale | During ICU stay (expected average of 2 weeks) | From 0 (no pain) to 10 (worst pain possible) |
| Ketamine consumption | During ICU stay (expected average of 2 weeks) | Ketamine administration during NIV session (mg/kg/h) |
| 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 |
| Morphine consumption | During ICU stay (expected average of 2 weeks) | Morphine administration during NIV session (mg/kg/h) |
Countries
France
Outcome results
None listed