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Completed

NCT Number: NCT02537366

Dexmedetomidine for Non-invasive Ventilation After Chest Trauma

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.

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Key information

Conditions

Thoracic Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Grenoble

Grenoble, 38043, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Placebo

Drug

Primary outcomes

  1. Duration of NIV session

    Time frame: During ICU stay (expected average of 2 weeks)

    Minutes

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: VENDETTA

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 1, 2015
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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