Clinical Trials Directory

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.