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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00919971
Acronym
OHBIS
Enrollment
120
Registered
2009-06-12
Start date
2009-06-30
Completion date
2011-07-31
Last updated
2011-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilation

Keywords

Bi spectral Index, Sedation depth monitoring, Out of hospital ventilated patients

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.

Interventions

None listed

Sponsors

Beaujon Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \>= 18 * Ventilated patient

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
Correlation between BIS values and RAMSAY scoreInstantaneously

Secondary

MeasureTime frame
Correlation between BIS values and ATICE scoreInstantaneously

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026