跳至主要内容
临床试验/CTRI/2025/09/094478
CTRI/2025/09/094478尚未招募不适用

“Comparison between Full Outline of UnResponsiveness (FOUR) score and Glasgow Coma Scale-Pupils (GCS-P) Score for predicting outcome in the patients after cardiac arrest- a prospective observational study”

Jaslok Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年9月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
102
试验地点
1
主要终点
To assess FOUR score and GCS-P score in terms of their ability to predict in-hospital mortality in patients after cardiac arrest

研究概览

简要总结

After procuring approval from the institutional ethics committee, we will prospectively enroll the patients who are satisfying the inclusion criteria. While the patients satisfying the exclusion criteria will be excluded. The study will be carried out for a period of 18 months.  The representative of the subject will be explained about the study and a written valid informed consent for their willingness will be taken before enrolling the patient for the study. The patients will be shifted to the ICU, after resuscitating them as per the recent ACLS (Advanced Cardiovascular Life Support) guidelines. After stabilizing the patient in the ICU; the patient’s demographic details, details of comorbidities (if any), previous history of cardiac arrest and resuscitation, and details of previous surgeries (if any) will be noted. Following this, a thorough neurological assessment will be done to record the FOUR score and GCS-P score. The length of stay of the patient in ICU after cardiac arrest will also be noted. Similar neurological assessments will be done at 24 hours, 48 hours, 72 hours, and 120 hours after the cardiac arrest to note down GCS-P and FOUR scores. In-hospital mortality for the enrolled patients will be noted. The functional neurological outcome will be assessed at discharge and 3 months after the cardiac arrest, using the Modified Rankin Scale (mRS). After 3 months, this assessment will be done physically, if the patients are still staying in Mumbai. In case the patient is not staying in Mumbai; we will telephonically communicate with the family physician who is taking care of the patient and will accordingly note down the findings of the assessment. In case the family physician is not involved in the patient care, we will assess the patient using a video call.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients getting admitted in the ICU of Jaslok Hospital and Research Centre, after an episode of cardiac arrest.
  • Patients who are already admitted in the ICU of Jaslok Hospital and Research Centre; and are not on any invasive ventilatory support or ionotropic supports or any palliative care; and then have an episode of sudden cardiac arrest.

排除标准

  • Refusal by the legally accepted representative to enroll the patient for this study.
  • Patients who are on invasive ventilatory support, already admitted in the ICU of Jaslok Hospital and Research Centre; and then have an episode of sudden cardiac arrest
  • Patients who are on ionotropic supports, already admitted in the ICU of Jaslok Hospital and Research Centre; and then have an episode of sudden cardiac arrest.
  • Patients who are on palliative care, already admitted in the ICU of Jaslok Hospital and Research Centre; and then have an episode of sudden cardiac arrest.
  • Patients who died within 6 hours of ICU admission, after an episode of cardiac arrest.

结局指标

主要结局

To assess FOUR score and GCS-P score in terms of their ability to predict in-hospital mortality in patients after cardiac arrest

时间窗: In-hospital mortality whenever it happens

次要结局

  • To evaluate FOUR score & GCS-P score in terms of their ability to predict functional neurological outcome in patients who survive after an episode of cardiac arrest.(Modified Rankin Scale score at discharge & at 3 months)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Akshay Yadav

aslok Hospital and Research Centre, 15, Dr G D Marg, Mumbai, Maharashtra

研究点 (1)

Loading locations...

相似试验