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

Primary Purpose

Thoracic Injuries

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Dexmedetomidine
Placebo
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

DEX

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Duration of NIV session
Minutes

Secondary Outcome Measures

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

Full Information

First Posted
August 21, 2015
Last Updated
March 8, 2017
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02537366
Brief Title
Dexmedetomidine for Non-invasive Ventilation After Chest Trauma
Acronym
VENDETTA
Official Title
Dexmedetomidine for Non-invasive Ventilation After Chest Trauma (VENDETTA)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thibaut TROUVE-BUISSON, PH
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Learn more about this trial

Dexmedetomidine for Non-invasive Ventilation After Chest Trauma

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