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Impact of dexmedetomidine on preventive noninvasive ventilation in thoracic trauma - VENDETTA

Impact of dexmedetomidine on preventive noninvasive ventilation in thoracic trauma - VENDETTA

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-002210-71-FR
Enrollment
Unknown
Registered
2015-07-27
Start date
2015-07-01
Completion date
Unknown
Last updated
2015-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic trauma

Interventions

Trade Name: DEXDOR Product Name: DEXDOR Pharmaceutical Form: Concentrate for solution for infusion Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: In

Sponsors

University Hospital Grenoble
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Patient hospitalized in intensive care or USC • Patient with a closed chest trauma not intubated (TTS score> 6) • Patient row to social security • Major Patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: • EVA Rest> 3 • Agitation with RASS> 2 • Patient on DEX or treated with an alpha 2 agonist in the last 8 hours • Patients on home VNI (except for VS-PPC OSA) • analgesia by epidural catheter • Long-term treatment with neuroleptics • Contraindications to the VNI • Contraindications to the DEX

Design outcomes

Primary

MeasureTime frame
Main Objective: Compare the length of the sessions of VNI under DEX and placebo in the thoracic trauma patient;Secondary Objective: 1) To compare the safety of the patient during the session of VNI in DEX through hetero assessment scales (RASS) and self-assessment (EVA dyspnea, pain EVA, analgesic consumption during the sessions). 2) Compare the effectiveness of the VNI on arterial blood gases according to sedation 3) Evaluate the safety: a collection of the number of adverse events attributable to DEX at meetings.;Primary end point(s): Duration of VNI sessions with and without DEX (minutes)

Countries

France

Contacts

Public ContactDr TROUVE-BUISSON

University Hospital Grenoble

TTrouve-buisson@chu-grenoble.fr3304 76 76 52 95

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026