Dexmedetomidine for Non-invasive Ventilation After Chest Trauma

NCT02537366 | Completed Phase 4 DMC

• 1 other identifier: EssaiClinique-VENDETTA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Injuries

Outcome Measures

Primary Outcomes (1)

• Duration of NIV session

  Minutes

  During ICU stay (expected average of 2 weeks)

Secondary Outcomes (11)

• Richmond Agitation-Sedation Scale

  During ICU stay (expected average of 2 weeks)

• Number of interventions on NIV settings

  During ICU stay (expected average of 2 weeks)

• Morphine consumption

  During ICU stay (expected average of 2 weeks)

• Ketamine consumption

  During ICU stay (expected average of 2 weeks)

• Pain visual analogue scale

  During ICU stay (expected average of 2 weeks)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

DEX

EXPERIMENTAL

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

Interventions

Dexmedetomidine DRUG

DEX

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Blunt chest trauma with thoracic trauma score\> 6, ICU admission and spontaneous breathing

You may not qualify if:

• Contra indication for NIV or Dexmedetomidine as specified by the French marketing authorization

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU de Grenoble

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Thoracic Injuries

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Thibaut TROUVE-BUISSON, PH

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: September 1, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 9, 2017

Record last verified: 2017-03

Locations

FR (1)