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

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ClinicalTrials.gov Identifier: NCT00919971
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : October 19, 2011
Sponsor:
Information provided by (Responsible Party):
Francois-Xavier Duchateau, 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.

Condition or disease
Ventilation

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
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Use of Bispectral Index to Assess Depth of Sedation in Ventilated Patients in the Prehospital Setting
Study Start Date : June 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011



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

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


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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
Criteria

Inclusion Criteria:

  • Age >= 18
  • Ventilated patient

Exclusion criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919971


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

Responsible Party: Francois-Xavier Duchateau, MD, Beaujon Hospital
ClinicalTrials.gov Identifier: NCT00919971     History of Changes
Other Study ID Numbers: OHBIS
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: October 19, 2011
Last Verified: October 2011

Keywords provided by Francois-Xavier Duchateau, Beaujon Hospital:
Bi spectral Index
Sedation depth monitoring
Out of hospital ventilated patients