- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00919971
Bispectral Index (BIS) on Ventilated Patients in the Prehospital Setting (OHBIS)
October 18, 2011 updated by: Francois-Xavier Duchateau, Beaujon Hospital
Use of Bispectral Index to Assess Depth of Sedation in Ventilated Patients in the Prehospital Setting
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 Overview
Status
Completed
Conditions
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
Observational
Enrollment (Anticipated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Clichy, France, 92110
- François-Xavier DUCHATEAU, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Out of hospital ventilated patients, managed by EMS, aged > 18
Description
Inclusion Criteria:
- Age >= 18
- Ventilated patient
Exclusion criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between BIS values and RAMSAY score
Time Frame: Instantaneously
|
Instantaneously
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between BIS values and ATICE score
Time Frame: Instantaneously
|
Instantaneously
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
June 9, 2009
First Submitted That Met QC Criteria
June 11, 2009
First Posted (Estimate)
June 12, 2009
Study Record Updates
Last Update Posted (Estimate)
October 19, 2011
Last Update Submitted That Met QC Criteria
October 18, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- OHBIS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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