Dexmedetomidine for Non-invasive Ventilation After Chest Trauma

Thoracic Injuries Clinical Trial

— VENDETTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537366
• Other study ID #: EssaiClinique-VENDETTA
• Status: Completed
• Phase: Phase 4
• First received: August 21, 2015
• Last updated: March 8, 2017
• Start date: September 2015
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Injuries

Intervention

Drug:
• Dexmedetomidine

• Placebo

Locations

Country	Name	City	State
France	CHU de Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

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