跳至主要内容
临床试验/CTRI/2025/01/079060
CTRI/2025/01/079060尚未招募3 期

The effect of very early tracheostomy versus early tracheostomy on weaning from mechanical ventilation in patient with moderate to severe traumatic brain injury- A Prospective randomized comparative study

Department of Anaesthesiology and Critical Care1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年1月30日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
56
试验地点
1
主要终点
Duration taken to wean off from mechanical ventilator in terms of number of days

研究概览

简要总结

Patients with TBI have to be admitted in intensive care unit (ICU) for comprehensive systemic and cerebral care. According to the CENTER-TBI study, 31% of TBI patients required tracheostomies. Traditionally, tracheostomies conducted within the first week are classified as early, whereas those performed after seven days are considered late. Early tracheostomy is thought to potentially reduce the duration of MV and the length of ICU stay. It may also decrease the risk of VAP and other complications associated with prolonged intubation. On the other hand, late tracheostomy might reduce the immediate risks associated with the procedure and allow for a better assessment of the patient’s potential for recovery. Therefore, lack of clarity underscores the need of further prospective studies to improve

outcome of TBI patients requiring tracheostomy. In our study,  traumatic brain injury patients will be be grouper as Group VE- Patients belong to group VE will get tracheostomy done in day 1 of admission to NTICU. Group ET- Patients belong to ET will get tracheostomy done on day 5 of admission to NTICU. Primary outcome - number of days to wean off from ventilator and also we study number of days patient takes to discharge,  occurrence ventilator associated pneumonia,  sepsis and any other complications in ICU.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients with isolated moderate to severe TBI (GCS 6-12) 2.Rotterdam score 3 and above 3.ASA IE, IIE, IIIE 4.Presentation to hospital within 24 hours of injury 5.Consent for participation in the study from legal heir.

排除标准

  • 1.Patients with hemoglobinopathies, deranged coagulation parameters.
  • 2.Preoperative hemodynamically unstable patients requiring vasopressors / inotropes, polytrauma.
  • 3.Pregnant patients 4.Patients with chronic liver disease, renal disease and decompensated heart failure 5.History of emergency tracheostomy
  • Anatomical deformity of the neck 7.Refusal to participate in the study
  • Severe respiratory distress with refractory hypoxemia and hypercapnia.

结局指标

主要结局

Duration taken to wean off from mechanical ventilator in terms of number of days

时间窗: First point of ventilator free. It will be in days

次要结局

  • 1. Incidence of VAP (ventilator associated pneumonia)(2.Incidence of tracheostomy related complication)

研究者

发起方
Department of Anaesthesiology and Critical Care
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr MAHESHVARAN M

Post Graduate Institute of Medical Education and Research

研究点 (1)

Loading locations...

相似试验