Bispectral Index (BIS) on Ventilated Patients in the Prehospital Setting

Completed

• Conditions: Ventilation

• Registration Number: NCT00919971
• Lead Sponsor: Beaujon Hospital

Brief 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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-11
• Study First Posted: 2009-06-12
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-18
• Last Update Posted: 2011-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age >= 18
• Ventilated patient

Exclusion criteria:

• None

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between BIS values and RAMSAY score	Instantaneously

Secondary Outcome Measures

Name	Time	Method
Correlation between BIS values and ATICE score	Instantaneously

Trial Locations

Locations (1)

François-Xavier DUCHATEAU, MD; 🇫🇷 Clichy, France