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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Thoracic Injuries Drug: Dexmedetomidine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Dexmedetomidine for Non-invasive Ventilation After Chest Trauma (VENDETTA)
Actual Study Start Date : September 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
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)
Drug: Dexmedetomidine



Primary Outcome Measures :
  1. Duration of NIV session [ Time Frame: During ICU stay (expected average of 2 weeks) ]
    Minutes


Secondary Outcome Measures :
  1. Richmond Agitation-Sedation Scale [ Time Frame: During ICU stay (expected average of 2 weeks) ]
    From -5 (Unarousable) to +4 (Combative)

  2. Number of interventions on NIV settings [ Time Frame: During ICU stay (expected average of 2 weeks) ]
  3. Morphine consumption [ Time Frame: During ICU stay (expected average of 2 weeks) ]
    Morphine administration during NIV session (mg/kg/h)

  4. Ketamine consumption [ Time Frame: During ICU stay (expected average of 2 weeks) ]
    Ketamine administration during NIV session (mg/kg/h)

  5. Pain visual analogue scale [ Time Frame: During ICU stay (expected average of 2 weeks) ]
    From 0 (no pain) to 10 (worst pain possible)

  6. 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

  7. Variation of arterial partial pressure of dioxygen (O2) before and after NIV session [ Time Frame: During ICU stay (expected average of 2 weeks) ]
    mmHg

  8. Variation of potential hydrogen (pH) before and after NIV session [ Time Frame: During ICU stay (expected average of 2 weeks) ]
  9. Reproductibility of NIV sessions [ Time Frame: During ICU stay (expected average of 2 weeks) ]
    Minutes

  10. Bradycardia [ Time Frame: During ICU stay (expected average of 2 weeks) ]
    Mean arterial pressure less than 55 mmHg

  11. Hypotension [ Time Frame: During ICU stay (expected average of 2 weeks) ]
    Heart rate less than 40 / mn



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537366


Locations
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France
CHU de Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Thibaut TROUVE-BUISSON, PH University Hospital, Grenoble
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02537366    
Other Study ID Numbers: EssaiClinique-VENDETTA
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Thoracic Injuries
Wounds and Injuries
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action