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Crossover randomized controlled double blinded trial :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of NIV session | Minutes | During ICU stay (expected average of 2 weeks) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thibaut TROUVE-BUISSON, PH | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Grenoble | Grenoble | 38043 | France |
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| ID | Term |
|---|---|
| D013898 | Thoracic Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| 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) |