Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Francois-Xavier Duchateau, Beaujon Hospital Identifier:
First received: June 9, 2009
Last updated: October 18, 2011
Last verified: October 2011
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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Use of Bispectral Index to Assess Depth of Sedation in Ventilated Patients in the Prehospital Setting

Further study details as provided by Beaujon Hospital:

Primary Outcome Measures:
  • Correlation between BIS values and RAMSAY score [ Time Frame: Instantaneously ]

Secondary Outcome Measures:
  • Correlation between BIS values and ATICE score [ Time Frame: Instantaneously ]

Estimated Enrollment: 120
Study Start Date: June 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Out of hospital ventilated patients, managed by EMS, aged > 18

Inclusion Criteria:

  • Age >= 18
  • Ventilated patient

Exclusion criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00919971

François-Xavier DUCHATEAU, MD
Clichy, France, 92110
Sponsors and Collaborators
Beaujon Hospital
  More Information

Responsible Party: Francois-Xavier Duchateau, MD, Beaujon Hospital Identifier: NCT00919971     History of Changes
Other Study ID Numbers: OHBIS
Study First Received: June 9, 2009
Last Updated: October 18, 2011

Keywords provided by Beaujon Hospital:
Bi spectral Index
Sedation depth monitoring
Out of hospital ventilated patients processed this record on May 25, 2017