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临床试验/CTRI/2020/02/023466
CTRI/2020/02/023466招募中2 期

Comparison of Pressure support ventilation and T-piece ventilation during spontaneous breathing trials on successful extubation among patients on mechanical ventilation.

Johnson1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年2月24日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
发起方
Johnson
入组人数
160
试验地点
1
主要终点
To compare pressure support ventilation and T-piece ventilation in providing successful extubation among mechanically ventilated patients.

研究概览

简要总结

Delayed weaning can lead to a number of complications like ventilator induced lung injury (VILI), ventilator associated pneumonia (VAP) and ventilator induced diaphragmatic dysfunction. In an intensive care unit, spontaneous breathing trials are routinely conducted to facilitate decision making regarding timely extubation and to reduce the patient’s chance of getting into the above-mentioned unfavorable conditions or invasive ventilation. Daily SBTs are the best approach to determine whether patients are ready for disconnection from mechanical ventilation, but mode and duration remains controversial. Hence in this study, pressure support and T-piece SBTs are compared in providing successful extubation.

 Research question / hypothesis:

Whether a 30-minute Pressure support ventilation as compared to a 2-hour T-piece ventilation has atleast 15% higher rates of successful extubation among adult patients on mechanical ventilation?

 Study procedure:

A. Patients in MICU and emergency ICU who fulfil the inclusion criteria will be recruited to the study.

B. Once the patient is found to satisfy the inclusion criteria, consent will be taken from the patient for recruitment into the study. If the patient cannot give consent, consent will be obtained from his next of kin.

C. Participants will be randomly divided into two arms (T-piece arm and pressure support arm).

D. Detailed history and examination of all the patients will be documented.

E. Patients under both arms will undergo baseline laboratory investigations like chest X-ray, arterial blood gas analysis, complete blood count, renal function tests, liver function test and serum electrolytes.

F. Primary diagnosis will be established for all cases. APACHE II scores will be calculated and recorded.

G. Patients in group A will undergo a 2-hour T-piece SBT.

H. Similarly, Patients in group B will undergo a 30 minutes pressure support SBT with 8 cm H2O pressure.

I. FiO2 will remain unchanged from the mechanical ventilation period leading upto the SBT.

J. During weaning, if any patient fulfils the criteria for weaning failure, they will be considered failure of the particular weaning mode that he is on.

K. Patients who complete the SBT successfully will be extubated and will be observed for the next 72 hours to see if they are capable of sustaining without reintubation or Non-invasive positive pressure ventilation. Patients who required reintubation or NIPPV as decided by the treating clinicians will be considered as weaning failure.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • •1.Patients aged 18 years or older.
  • •2.Patients undergoing mechanical ventilation for atleast 24 hours considered eligible for weaning by the following weaning criteria: A.Patient who are alert and co-operative.
  • •B.The resolution or improvement of the condition leading to intubation.
  • •C.Hemodynamical stability, defined as systolic blood pressure between 90 and 160 mmHg and heart rate less than 140/min without vasopressors or with low doses of vasopressors.
  • •D.Glasgow coma scale of 8 or greater.
  • •E.Respiratory stability, defined as oxygen saturation > 90% with FiO2 < 0.5, PEEP ≤ 5cm H2O, respiratory rate < 30/min, spontaneous tidal volume > 5mL/kg, PF ratio >
  • •F.Non-copious secretions (<3 aspirations in the last 8 hours).
  • •G.Diaphragmatic thickness fraction >
  • •I.Patients in spontaneous intermittent mandatory ventilation (SIMV) mode with a pressure support of 8.

排除标准

  • •1.Pregnant women.
  • •2.Patients with diaphragm paralysis.
  • •3.Patients with neuromuscular disorders.
  • •4.Patients on tracheostomy.

结局指标

主要结局

To compare pressure support ventilation and T-piece ventilation in providing successful extubation among mechanically ventilated patients.

时间窗: 3 days

次要结局

  • 1.To determine the rate of successful extubation.(2.To determine the rate of weaning failure)

研究者

发起方
Johnson
申办方类型
Other [self]

研究点 (1)

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