Comparison of Positive Pressure Extubation with Traditional Extubation in critically ill patients- A Randomised control study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Comparison of lung aeration of patients who undergo traditional extubation with those undergoing positive pressure extubation using lung ultrasound.
研究概览
简要总结
The patient who is in the ICU and is connected to a ventilator using an endotracheal tube for atleast 72 hours, will undergo treatment as per the hospital protocol. All baseline medical details and cause of admission will be noted. A baseline Chest X-ray will be taken before extubation as well as within 24 hours after extubation. The patient will either be in the positive pressure or traditional extubation group based on a randomization process. Based on the group he/she will be extubated after tracheal suctioning and deflation of the cuff directly or extubated after 5 minutes of further ventilator support (PS -15 cm H2O , PEEP- 10 cm H2O) without tracheal suctioning. Lung ultrasound will be done before extubation and at various time periods (30 mins, 6 hrs, 24 hrs) after extubation. Blood samples of the patient will be taken for monitoring the oxygenation of the patient. Sputum samples of the patient will be taken for culture and antibiotic sensitivity if needed as per hospital protocol. Our research work involves observing and noting down these lab results of the patient for 48 hours after the patient is extubated. Apart from these lab values, we will also note down other details of the patient during their ICU stay, like the need for reintubation, any changes in blood pressure, heart rate, respiratory rate or oxygen levels in the blood, any worsening in chest X-ray films or any other adverse events such as pneumonia and bronchospasm. Lung USG scores will be compared between the 2 groups. Reintubation rates and ICU free days are also calculated. Our aim is to assess whether lung aeration improves after positive pressure extubation and whether other parameters measured are improved after the same.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients mechanically ventilated with an endotracheal tube for at least 72 hours Patients deemed fit for extubation by the following criteria or by the physicians discretion PaO2 greater than or equal to 60 mm Hg on FIO2 lesser than or equal to 50 percentage SaO2 greater than or equal to 90% on FIO2 lesser than or equal to 50 percentage pH greater than or equal to 7.32 or a decrease in pH less than 0.07 from baseline of SBT Rapid shallow breathing index less than 105 breaths per min per Litre Respiratory rate less than or equal to 35 breaths per min or increase less than 50 percentage from baseline of SBT Hemodynamically stable patient Successful T-piece or Pressure support ventilation trial for 30 minutes.
排除标准
- •Patients planned in advance to be extubated directly to NIV or High flow nasal cannula Patients with severe asthma bullous lung disease or severe emphysematous lung disease Patients with suspected raised ICP Patients with a poor GCS of less than 8.
结局指标
主要结局
Comparison of lung aeration of patients who undergo traditional extubation with those undergoing positive pressure extubation using lung ultrasound.
时间窗: End of SBT | 30 Mins Post Extubation | 6 Hours Post Extubation | 24 Hours Post Extubation
次要结局
- Change in the A-aO2 gradient pre and post extubation in the two groups(End Of SBT)
- Chest X-ray findings between the two groups(Before Extubation)
- Change in lung ultrasound scores pre and post extubation in the two groups(End of SBT)
- Incidence of adverse clinical events between the two groups(Extubation failure within 48 hours)
- ICU free days and Reintubation rates between the two groups(ICU free days at 28 days)