FOUR Score in Children With Non-traumatic Impairment of Consciousness

NCT01537913 | Completed

• 1 other identifier: FOUR_Score
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hypothesis: FOUR score is a better predictor of outcome (in hospital mortality and functional outcome at discharge) than GCS in children 5- 18 years age admitted in pediatric ward/ ICU with non-traumatic impaired consciousness. The assessment of comatose patients is an important part of critical care. The assessment of the level of coma relies on clinical scores. The Glasgow Coma Scale (GCS),remains the most commonly used scoring system for altered state of consciousness. Despite its widespread use, a number of limitations have been identified with GCS like inability to assess verbal score in intubated patients and non-inclusion of vital brainstem functions. The FOUR (Full Outline of UnResponsiveness) score, a coma scale consisting of four components (eye response, motor response, brainstem reflexes, and respiration pattern) was recently proposed by investigators from the Mayo Clinic.keeping in view the limitations of GCS, this study was planned to compare the new FOUR score with GCS as a predictor of mortality and poor functional outcome at hospital discharge.

Conditions

Impaired Consciousness

Outcome Measures

Primary Outcomes (1)

• In-hospital Mortality

  From admission till discharge/ in-hospital mortality

Secondary Outcomes (1)

• Pediatric Overall Performance Category scale (POPC) scale

  1 month or discharge whichever is earlier

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children aged 5-18 years, admitted in PICU or pediatric ward with impaired consciousness of less than 7 days duration

You may qualify if:

• Children aged 5-18 years
• Meeting the definition of impaired consciousness52
• Admitted in PICU or pediatric ward
• Duration \< 7 days

You may not qualify if:

• Traumatic brain injury
• Patients already on sedatives or neuromuscular blockade
• Children with cerebral palsy, severe mental retardation, degenerative brain disease.
• Known vision/Hearing impairment
• Ongoing seizures or seizure within last 1 hour

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Officials

• Gurpreet S Kochar, DM

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Sheffali Gulati

  All India Institute of Medical Sciences

  STUDY DIRECTOR

• Rakesh Lodha

  All India Institute of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Comparison of the Full Outline of Unresponsiveness (FOUR) Score and the Glasgow Coma Scale (GCS) in children with non-traumatic impairment of consciousness

Study Record Dates

• First Submitted: February 18, 2012
• First Posted: February 23, 2012
• Study Start: June 1, 2009
• Study Completion: June 1, 2010
• Last Updated: February 23, 2012

Record last verified: 2012-02