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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Francois-Xavier Duchateau, Beaujon Hospital

ClinicalTrials.gov Identifier:

NCT00919971

First received: June 9, 2009

Last updated: October 18, 2011

Last verified: October 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	June 9, 2009
Last Updated Date	October 18, 2011
Start Date ^ICMJE	June 2009
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 11, 2009)	Correlation between BIS values and RAMSAY score [ Time Frame: Instantaneously ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00919971 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 11, 2009)	Correlation between BIS values and ATICE score [ Time Frame: Instantaneously ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Bispectral Index (BIS) on Ventilated Patients in the Prehospital Setting
Official Title ^ICMJE	Use of Bispectral Index to Assess Depth of Sedation in Ventilated Patients in the Prehospital Setting
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 Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Out of hospital ventilated patients, managed by EMS, aged > 18
Condition ^ICMJE	Ventilation
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	120
Completion Date	July 2011
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age >= 18 Ventilated patient Exclusion criteria: None
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT00919971
Other Study ID Numbers ^ICMJE	OHBIS
Has Data Monitoring Committee	No
Responsible Party	Francois-Xavier Duchateau, Beaujon Hospital
Study Sponsor ^ICMJE	Beaujon Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Beaujon Hospital
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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