NCT02049320

Brief Summary

This is a descriptive retrospective study designed to measure the efficacy of remifentanil sedation and the ability to perform frequent neurological examinations of patients with traumatic brain injuries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2013

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

July 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

2.8 years

First QC Date

January 13, 2014

Last Update Submit

January 31, 2017

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Depth of Sedation

    Sedation scores will be assessed.

    Every 24 hrs until discharged from the PICU, up to 1 month.

Study Arms (1)

Remifentanil

Patients sedated using Remifentanil

Drug: Remifentanil

Interventions

RemifentanilDRUG
Remifentanil

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering a traumatic brain injury who were sedated in the PICU using remifentanil.

You may qualify if:

  • Patients previously admitted to the hospital presenting with traumatic brain injury (TBI)
  • Patients who have undergone sedation after presenting with TBI

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chairman - Dept. of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 30, 2014

Study Start

July 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

US(1)