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

NCT ID: NCT00919971

Last Updated: 2011-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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Ventilation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age \>= 18
* Ventilated patient

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beaujon Hospital

OTHER

Sponsor Role lead

Responsible Party

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Francois-Xavier Duchateau

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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François-Xavier DUCHATEAU, MD

Clichy, , France

Site Status

Countries

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France

Other Identifiers

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OHBIS

Identifier Type: -

Identifier Source: org_study_id