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

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

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Injuries
• Intervention / Treatment: Drug: Placebo; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • CHU de Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of NIV session	Minutes	During ICU stay (expected average of 2 weeks)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Thibaut TROUVE-BUISSON, PH, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: August 21, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 1, 2015

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: EssaiClinique-VENDETTA