We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00919971
First Posted: June 12, 2009
Last Update Posted: October 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Francois-Xavier Duchateau, Beaujon Hospital
  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 Francois-Xavier Duchateau, Beaujon Hospital:

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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:

  Contacts and Locations
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
  More Information

Responsible Party: Francois-Xavier Duchateau, MD, Beaujon Hospital
ClinicalTrials.gov Identifier: NCT00919971     History of Changes
Other Study ID Numbers: OHBIS
First Submitted: June 9, 2009
First Posted: June 12, 2009
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


To Top