NCT00919971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

October 19, 2011

Status Verified

October 1, 2011

Enrollment Period

2.1 years

First QC Date

June 9, 2009

Last Update Submit

October 18, 2011

Conditions

Ventilation

Keywords

Bi spectral IndexSedation depth monitoringOut of hospital ventilated patients

Outcome Measures

Primary Outcomes (1)

  • Correlation between BIS values and RAMSAY score

    Instantaneously

Secondary Outcomes (1)

  • Correlation between BIS values and ATICE score

    Instantaneously

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Out of hospital ventilated patients, managed by EMS, aged \> 18

You may qualify if:

  • Age \>= 18
  • Ventilated patient

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

François-Xavier DUCHATEAU, MD

Clichy, 92110, France

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 12, 2009

Study Start

June 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 19, 2011

Record last verified: 2011-10

Locations

FR(1)