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Clinical Trials/NCT00919971
NCT00919971
Completed
N/A

Use of Bispectral Index to Assess Depth of Sedation in Ventilated Patients in the Prehospital Setting

Beaujon Hospital1 site in 1 country120 target enrollmentJune 2009
ConditionsVentilation

Overview

Phase
N/A
Intervention
Not specified
Conditions
Ventilation
Sponsor
Beaujon Hospital
Enrollment
120
Locations
1
Primary Endpoint
Correlation between BIS values and RAMSAY score
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
July 2011
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Beaujon Hospital
Responsible Party
Principal Investigator
Principal Investigator

Francois-Xavier Duchateau

MD

Beaujon Hospital

Eligibility Criteria

Inclusion Criteria

  • Age \>= 18
  • Ventilated patient
  • Exclusion criteria:

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Correlation between BIS values and RAMSAY score

Time Frame: Instantaneously

Secondary Outcomes

  • Correlation between BIS values and ATICE score(Instantaneously)

Study Sites (1)

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