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

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.

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Key information

Conditions

Ventilation Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

François-Xavier DUCHATEAU, MD

Clichy, 92110, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age >= 18
Ventilated patient

Exclusion criteria

None

Treatment and study plan

Primary outcomes

Correlation between BIS values and RAMSAY score

Time frame: Instantaneously

Secondary outcomes

Correlation between BIS values and ATICE score

Time frame: Instantaneously

Sponsors and collaborators

Lead sponsor

Beaujon Hospital

Other

Registry information

Official study title

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

Acronym: OHBIS

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Jun 12, 2009
Registry last updated: Oct 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed