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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francois-Xavier Duchateau, Beaujon Hospital
ClinicalTrials.gov Identifier:
NCT00919971
First received: June 9, 2009
Last updated: October 18, 2011
Last verified: October 2011
History of Changes
  Purpose

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
Ventilation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Use of Bispectral Index to Assess Depth of Sedation in Ventilated Patients in the Prehospital Setting

Further study details as provided by Beaujon Hospital:

Primary Outcome Measures:
  • Correlation between BIS values and RAMSAY score [ Time Frame: Instantaneously ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between BIS values and ATICE score [ Time Frame: Instantaneously ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919971

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

No publications provided

Responsible Party: Francois-Xavier Duchateau, MD, Beaujon Hospital
ClinicalTrials.gov Identifier: NCT00919971     History of Changes
Other Study ID Numbers: OHBIS
Study First Received: June 9, 2009
Last Updated: October 18, 2011
Health Authority: France: Ministry of Health

Keywords provided by Beaujon Hospital:
Bi spectral Index
Sedation depth monitoring
Out of hospital ventilated patients

ClinicalTrials.gov processed this record on June 18, 2013