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临床试验/CTRI/2024/08/072659
CTRI/2024/08/072659尚未招募不适用

Evaluation of the role of mechanical power normalised for static compliance in predicting weaning outcome of patients receiving invasive mechanical ventilation for acute respiratory distress syndrome.

All India institute of medical sciences Rishikesh1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2024年9月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
124
试验地点
1
主要终点
Efficacy of mechanical power normalised to static compliance in predicting weaning failure in patients with acute respiratory distress syndrome.

研究概览

简要总结

Patients satisfying clinical criteria for ARDS according to Berlin definition will be included. At baseline, patients will be  maintained deeply sedated and paralysed, ventilated in volume control with a square wave form without any inspiratory pause, applying a tidal volume between 4-6 mL/kg of ideal body weight with a PEEP value and FiO2  set by the attending physician to ensure an arterial saturation between 93 and 97%. At baseline, data will be  collected including age, sex, body mass index, Simplified Acute Physiology Score (SAPS II), cause for ARDS, PaO2/FiO2, PaCO2, and clinical mechanical ventilator setting (PEEP, respiratory rate, tidal volume). ARDS patients will be classified as mild (200 mmHg < PaO2/FiO2 ratio ≤ 300 mmHg), moderate (100 mmHg < PaO2/FiO2 ratio ≤ 200 mmHg), or severe (PaO2/FiO2 ratio ≤ 100 mmHg) according to the Berlin definition . Once the patients clinical condition improves is considered ready to wean ,under deep sedation the variables determining the mechanical power and plateau pressure will be  recorded. There after the sedation is stopped and gradual reduction in the mechanical ventilation support is done . Once patient fulfils the criteria for weaning  will be given SBT with CPAP of 5 cm of H20 And PS of 5cm of H2O Number of incidents of weaning failure will be recorded and correlated with the Mechanical power corrected to static compliance  Those who show intolerance to SBT or do not fulfil weaning protocol will be reinitiated on sedation, and reconsidered at 24 hrs interval by same methodology.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • 未提供

排除标准

  • Pregnancy
  • History of neuromuscular disease
  • Chest wall deformities
  • Intracranial hypertension
  • Refusal to consent.
  • Need of mechanical ventilation less than 24hr hours
  • Required long term ventilation within 3 months.
  • Associated Interstitial lung disease
  • Congestive cardiac failure
  • Patients with poor Sensorium
  • Patients with known history of asthma
  • Hemodynamically unstable.

结局指标

主要结局

Efficacy of mechanical power normalised to static compliance in predicting weaning failure in patients with acute respiratory distress syndrome.

时间窗: To be measured 24 hours before weaning trial and to assess need of ventilatory support till 48 hours after weaning

次要结局

  • To evaluate the efficacy of mechanical power normalised to Alveolar arterial gradient in predicting weaning failure in patients with acute respiratory distress syndrome.(24hrs before weaning)
  • To evaluate the value static compliance as a weaning predictor in patients with acute respiratory distress syndrome.(24 hrs before weaning)

研究者

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

Dr Vaishnavi Pandith

All India institute of medical sciences

研究点 (1)

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