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

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ClinicalTrials.gov Identifier: NCT02537366
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date  ICMJE August 21, 2015
First Posted Date  ICMJE September 1, 2015
Last Update Posted Date March 9, 2017
Actual Study Start Date  ICMJE September 2015
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
Duration of NIV session [ Time Frame: During ICU stay (expected average of 2 weeks) ]
Minutes
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
  • Richmond Agitation-Sedation Scale [ Time Frame: During ICU stay (expected average of 2 weeks) ]
    From -5 (Unarousable) to +4 (Combative)
  • Number of interventions on NIV settings [ Time Frame: During ICU stay (expected average of 2 weeks) ]
  • Morphine consumption [ Time Frame: During ICU stay (expected average of 2 weeks) ]
    Morphine administration during NIV session (mg/kg/h)
  • Ketamine consumption [ Time Frame: During ICU stay (expected average of 2 weeks) ]
    Ketamine administration during NIV session (mg/kg/h)
  • Pain visual analogue scale [ Time Frame: 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 [ Time Frame: During ICU stay (expected average of 2 weeks) ]
    mmHg
  • Variation of arterial partial pressure of dioxygen (O2) before and after NIV session [ Time Frame: During ICU stay (expected average of 2 weeks) ]
    mmHg
  • Variation of potential hydrogen (pH) before and after NIV session [ Time Frame: During ICU stay (expected average of 2 weeks) ]
  • Reproductibility of NIV sessions [ Time Frame: During ICU stay (expected average of 2 weeks) ]
    Minutes
  • Bradycardia [ Time Frame: During ICU stay (expected average of 2 weeks) ]
    Mean arterial pressure less than 55 mmHg
  • Hypotension [ Time Frame: During ICU stay (expected average of 2 weeks) ]
    Heart rate less than 40 / mn
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine for Non-invasive Ventilation After Chest Trauma
Official Title  ICMJE Dexmedetomidine for Non-invasive Ventilation After Chest Trauma (VENDETTA)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Thoracic Injuries
Intervention  ICMJE
  • Drug: Dexmedetomidine
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: 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)
    Intervention: Drug: Placebo
  • Experimental: DEX
    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)
    Intervention: Drug: Dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02537366
Other Study ID Numbers  ICMJE EssaiClinique-VENDETTA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thibaut TROUVE-BUISSON, PH University Hospital, Grenoble
PRS Account University Hospital, Grenoble
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP