Trials / Completed
CompletedNCT00919971
Bispectral Index (BIS) on Ventilated Patients in the Prehospital Setting
Use of Bispectral Index to Assess Depth of Sedation in Ventilated Patients in the Prehospital Setting
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 120 (estimated)
- Sponsor
- Beaujon Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the effectiveness of use of the bispectral index for monitoring of depth of sedation in ventilated patients during their prehospital management by a physician- staffed EMS. Hypothesis: there is a correlation between BIS and sedation scores.
Detailed description
The protocol compares BIS values to the RAMSAY score, which is the validated sedation scoring system in the prehospital setting.Ventilated patients receiving sedatives drugs can be included during primary prehospital interventions or interhospital transfers. During primary prehospital interventions, the protocol starts before endotracheal intubation. Depth of sedation is assessed every 5 minutes by the physician of EMS team. Blinded BIS monitoring is performed at the same time and recorded by the nurse at the end of out-of-hospital management. Data are analysed secondarily by the principal investigator.
Conditions
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2011-07-01
- Completion
- 2011-07-01
- First posted
- 2009-06-12
- Last updated
- 2011-10-19
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00919971. Inclusion in this directory is not an endorsement.