Dexmedetomidine for Non-invasive Ventilation After Chest Trauma
NCT ID: NCT02537366
Last Updated: 2017-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2015-09-30
2017-02-28
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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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)
Placebo
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)
Dexmedetomidine
Interventions
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Dexmedetomidine
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Thibaut TROUVE-BUISSON, PH
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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CHU de Grenoble
Grenoble, , France
Countries
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Other Identifiers
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EssaiClinique-VENDETTA
Identifier Type: -
Identifier Source: org_study_id
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