NCT00597740

Brief Summary

Purpose of Protocol: The purpose of this study will be to compare the clinical utility of Propofol sedation with and without the use of the ICU Sedation Protocol. Patients will be treated according to the attending/consulting preference. No attempt will be made to influence the patient's routine care and management. The study will compare the average hourly infusion rates for the Propofol administration, as well as obtain the nursing staffs evaluation regarding the ease of neurological assessment during each 12 hour shift

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 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

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 3, 2013

Status Verified

December 1, 2013

Enrollment Period

2.8 years

First QC Date

January 9, 2008

Last Update Submit

December 2, 2013

Conditions

Anesthesia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Neurotrauma ICU patients brought to our level one trauma facility requiring intubation.

You may qualify if:

  • Ages 18-80 (inclusive)
  • Admitted to trauma service
  • Intubated and on respiratory support
  • Neurosurgical consultation for closed head injury and/or spinal trauma
  • Informed consent from next of kin or POA

You may not qualify if:

  • Patients less than 18 or more than 80 years of age
  • GCS of 3 with bilaterally fixed and dilated pupils
  • Penetrating head trauma (e.g., gun shot wounds, nail gun injuries, etc.)
  • Pregnant women
  • Mentally impaired.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scottsdale Healthcare Osborn

Scottsdale, Arizona, 85251, United States

Location

Study Officials

  • Joseph Zabramski, MD

    Scottsdale Healthcare Osborn - Neurosurgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Compliance Administrator

Study Record Dates

First Submitted

January 9, 2008

First Posted

January 18, 2008

Study Start

December 1, 2007

Primary Completion

September 1, 2010

Study Completion

December 1, 2013

Last Updated

December 3, 2013

Record last verified: 2013-12

Locations

US(1)