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NCT00919971 Clinical Trial

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

Ventilation Clinical Trial

— OHBIS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00919971
Other study ID # OHBIS
Secondary ID
Status Completed
Phase N/A
First received June 9, 2009
Last updated October 18, 2011
Start date June 2009
Est. completion date July 2011

Study information
Verified date October 2011
Source Beaujon Hospital
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age >= 18

- Ventilated patient

Exclusion criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
France François-Xavier DUCHATEAU, MD Clichy

Sponsors (1)
Lead Sponsor Collaborator
Beaujon Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between BIS values and RAMSAY score Instantaneously No
Secondary Correlation between BIS values and ATICE score Instantaneously No
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