Comparison of the Full Outline of UnResponsiveness (FOUR) Score With Glasgow Coma Scale (GCS) in Children With Non-traumatic Impairment of Consciousness.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 主要终点
- In-hospital Mortality
研究概览
简要总结
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.
详细描述
This prospective observational study was carried out from May 2009 to June 2010 in the Department of Pediatrics, All India Institute of Medical Sciences, New Delhi. This study was approved by institutional ethics committee.
Participants We enrolled children aged 5-18 years who presented with impaired consciousness of less than 7 days duration and were admitted in the pediatric ward or pediatric ICU. Children with traumatic brain injury, known vision/hearing impairment, cerebral palsy, mental retardation, degenerative brain disease; those already on sedatives or neuromuscular blockade and with ongoing seizure or seizure within last 1 hour were excluded from the study.
Sample Size From the previous studies, it is known that ROC of GCS in children for prediction of mortality is 0.7.15 Assuming FOUR score to be better predictor of outcome (area under curve for FOUR score assumed to be 0.8), the sample size calculation was done using MedcalcR version 9.2.0.1. The correlation between both the scores and outcome was assumed to be 0.7. Keeping α-level as 0.05 and β-level as 0.20, the sample size was calculated to be 70.
Assessment Procedure The investigator (GK) was trained with the standardized video examples included in a DVD prepared by the developers of the FOUR score (Wijdicks et al10). After training, the investigator demonstrated the score on 2 patients while being supervised by Pediatric Neurologist. There was periodic training of the investigator every month by reviewing the case examples in DVD and rechecking the score periodically.
Written informed consent was obtained from the parents/ guardians for all patients. All the observations (required for the FOUR score and GCS) and investigations (required for PIM2) are done routinely in the children admitted in Pediatric ward/PICU. No additional investigations or interventions were done primarily for the study. Standardized care based on current guidelines was provided to all the patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5-18 years
- •Meeting the definition of impaired consciousness52
- •Admitted in PICU or pediatric ward
- •Duration < 7 days
排除标准
- •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
结局指标
主要结局
In-hospital Mortality
时间窗: From admission till discharge/ in-hospital mortality
次要结局
- Pediatric Overall Performance Category scale (POPC) scale(1 month or discharge whichever is earlier)
研究者
Gurpreet Kochar
Comparison of the Full Outline of Unresponsiveness (FOUR) Score and the Glasgow Coma Scale (GCS) in children with non-traumatic impairment of consciousness
All India Institute of Medical Sciences, New Delhi