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临床试验/CTRI/2025/02/080866
CTRI/2025/02/080866尚未招募不适用

A comparative study to evaluate the accuracy between cuff leak test & bedside laryngeal ultrasound in predicting post extubation stridor by intensivist- a prospective randomized comparative study

Sathya Narayanan K1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
76
试验地点
1
主要终点
Sensitivity, Specificity, Positive predictive value and Negative predictive value of Air column width difference , Air column width ratio and cuff leak test in patients prone for post extubation stridor.

研究概览

简要总结

Post-extubation stridor (PES) is the presence of inspiratory noise which develops post-extubation indicating narrowing of the airway with an incidence of 3-30%.[1]PES results in airway obstruction and respiratory distress which further accentuates hemodynamic instability and cardiac failure.[2] Stridor also results in negative pressure pulmonary oedema.[3] Risk Factors associated with PES includes older age, female gender, size of the endotracheal tube, prolonged intubation period, traumatic intubation and multiple intubation attempts. All of these can increase the mortality and morbidity, prolong the length of intensive care unit (ICU) stay and mechanical ventilation.Prior detection of PES prevents the need for reintubation, facilitates early treatment and recovery. The diagnosis of PES is critical as these patients can benefit from attentive monitoring and targeted therapy. Nonetheless, there is no consensus on how to identify patients at risk of PES. Cuff leak test demonstrates leak around the endotracheal tube when the cuff is deflated and is one of the simplest method proposed for predicting the occurrence of post extubation stridor. Ultrasound is bedside noninvasive tool in visualizing upper airway. The Air Column Width Difference predicts the occurrence of post extubation stridor.[4] The lacunae in the previous studies done to predict post extubation stridor had fewer patients in stridor group resulting in lower sensitivity.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Prolonged intubated state more than 3 days Prolonged intubation attempts more than 10 minutes Airway injury due to trauma or during intubation Airway surgery Recurrent Intubations Self- extubation with the cuff still inflated.

排除标准

  • Patients primarily intubated for the upper airway obstruction, having risk factor for tracheomalacia, or vocal cord paralysis with clinical presentation of stridor were excluded Patients or Parents or Caregivers refusal to give informed consent.
  • Patients less than 18 years of age Neuromuscular diseases.

结局指标

主要结局

Sensitivity, Specificity, Positive predictive value and Negative predictive value of Air column width difference , Air column width ratio and cuff leak test in patients prone for post extubation stridor.

时间窗: 0 minutes after admission ,at 1 day before extubation

次要结局

  • The incidence of Post extubation stridor

研究者

发起方
Sathya Narayanan K
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sathya NarayananK

Bangalore Medical College and Research Institute

研究点 (1)

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