Position of cuff of Microcuff Endotracheal Tube in Critically ill Children requiring Mechanical Ventilation and their outcomes - A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- To determine the proportion of children (age 1-11 years) on mechanical ventilation who have the cuff of microcuff endotracheal tube positioned at the level of the cricoid for at least 24 hours during the period of mechanical ventilation
研究概览
简要总结
After obtaining the approval from JSAC and IEC, JIPMER, this study will be registered in Clinical Trials Registry-India (CTRI). Children aged between 1 year to 11 years requiring mechanical ventilation in PICU, JIPMER and meeting the inclusion criteria will be recruited in this study. Written informed consent will be obtained from the legally acceptable representative (LAR) of the recruited children. The placement of the microcuff ETT will be confirmed by visualizing the passage of the tube between the vocal cords using a laryngoscope. The microcuff ETT will be fixed at the angle of the mouth on the right side after ensuring bilateral equal air entry in the lungs. All recruited children will be ventilated with a tidal volume of 6 to 8 ml.kg-1 of ideal body weight (IBW). The difference between the inhaled and exhaled tidal volumes (VT) will be compared. If the difference between the inhaled and exhaled VT is <10%, then the cuff will not be inflated. If the difference between exhaled VT and inhaled VT is >10%, then the microcuff will be inflated in increments of 0.5 ml of air until the difference falls to <10% between the inhaled and the exhaled VT. The pressure inside the microcuff will be monitored with a cuff pressure monitor every day and will be noted. USG of the airway will be performed to locate the position of the microcuff in the trachea and the image will be saved. This imaging will be performed once per day from day 2 of initiation of mechanical ventilation to till their extubation or until day 7 of mechanical ventilation. If the cuff of ETT is positioned at the level of the glottis, the ETT will repositioned to make sure the cuff is below the level of glottis. Children requiring mechanical ventilation for more than 7 days will be withdrawn from this study. If any child requires reintubation within 48 hours of extubation, it will be considered as extubation failure. Number of children developing stridor after extubation will be noted. The children who require reintubation will be intubated with videolaryngoscope and any edema of the airway (false cords, true cords) will be noted.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 11.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged between 1 year to 11 years intubated with microcuff endotracheal tube and requiring mechanical ventilation at least for 24 hours will be included in this study.
排除标准
- •Following children will be excluded from this study:
- •Children requiring reintubation due to any cause after extubation
- •Children with known airway anomalies
- •Children with a diagnosis of croup / TB / suppurative focus in the head and neck prior to intubation.
- •Children who undergo tracheostomy while on ventilator
- •Children with subcutaneous emphysema of the neck
- •Children with chronic CNS disease like cerebral palsy, neuro regression etc
- •Children with superior mediastinal syndrome.
结局指标
主要结局
To determine the proportion of children (age 1-11 years) on mechanical ventilation who have the cuff of microcuff endotracheal tube positioned at the level of the cricoid for at least 24 hours during the period of mechanical ventilation
时间窗: USG imaging of the position of the cuff will be studied once every day from day 2 of mechanical ventilation till 7 days or till extubation
次要结局
- To determine the duration in days in which the cuff of the microcuff endotracheal tube is positioned at the level of the cricoid during the entire period of mechanical ventilation in the recruited children(USG imaging of the position of the cuff will be studied once every day from day 2 of mechanical ventilation till 7 days or till extubation)
- To study the proportion of children with upper limit of cuff at the levels of 1st, 2nd and 3rd tracheal rings(USG imaging of the position of the cuff will be studied once every day from day 2 of mechanical ventilation till 7 days or till extubation)
- To compare the Proportion of children with extubation failure (defined as reintubation within 48 hours) between the children in whom the microcuff is positioned at the level of cricoid for at least 24 hours during mechanical ventilation with those in whom the cuff was never positioned at the level of cricoid for 24 hours.(From the time of extubation till 48 hours after extubation)
- To compare the frequency of occurrence of stridor (as assessed by Wesley stridor score) between the children in whom the micro cuff is positioned at the level of cricoid for at least 24 hours during mechanical ventilation with those in whom the cuff was never positioned at the level of cricoid for 24 hours.(from the time of extubation till 48 hours after extubation)
- To compare the frequency of occurance of airway oedema between the children in whom the micro cuff is positioned at the level of cricoid for at least 24 hours during mechanical ventilation with those in whom the cuff was never positioned at the level of cricoid for 24 hours.(From the time of extubation till 7 days after extubation)
- To determine the duration in days in which the cuff of the micro cuff endotracheal tube is positioned at the level of the cricoid during the entire period of mechanical ventilation in the recruited children
研究者
Dr Pankaj Kundra
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry