Comparison of endotracheal tube cuff pressures using manual vs. pressure gauge monitored technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary aim:
研究概览
简要总结
| The main function of an endotracheal tube (ETT) cuff is to maintain adequate sealing of airway, prevent gastro pharyngeal contents aspiration and ensure effective lung ventilation. One aspect of airway management is maintenance of an adequate pressure in the ETT cuff. A cuff pressure between 20 and 30 cm H2O is recommended to provide an adequate seal and reduce the risk of complications. The minimal occlusive intracuff pressure required for positive pressure ventilation, to prevent aspiration is approximately 20 cm H2O. Cuff pressure should not be more than 25 cm H2O (20-30 cm H2O) to maintain tracheal mucosa perfusion and thereby prevent mucosal ischemia, tracheal necrosis, rupture, stenosis, laryngeal nerve palsy and tracheoesophageal fistula. Endotracheal tube cuff pressure is usually not routinely measured and previous studies have demonstrated that cuff palpation is insufficient to detect high cuff pressure. Adequacy of ETT cuff inflation is usually checked by one of the following techniques: Manual palpation of the pilot balloon, disappearance of audible air leak through the mouth or the use of either an aneroid manometer (manual pressure gauge) or continuous automatic ETT cuff pressure controller. In the present study we will compare the endotracheal cuff pressure obtained via direct manual palpation of pilot balloon - with direct measurement via a Mallinckrodt cuff pressure gauge.From our study we found that - |
· The endotracheal tube cuff pressure increase gradually with time, especially with use of nitrous oxide. This rise can occur even with shorter duration surgeries, as was the case with our study.
· There is a rise in endotracheal tube cuff pressure even when manometer was first used for inflation of ETT cuff.
· Only 78% of experienced anesthetist could maintain the cuff pressure within the recommended range which shows that manual estimation techniques cannot be relied upon.
· A decrease in incidence of complications was noted in the control group (group C), where a manometer was used. Thus, intubation related morbidities can be reduced by doing vigilant monitoring of the intracuff pressure throughout the duration of intubation.
Thus, we conclude and recommend that endotracheal tube cuff inflation and frequent monitoring of the endotracheal tube cuff pressure by a simple tool like cuff pressure manometer should be introduced as a standard of practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
入选标准
- •Age: 18-75 years 2)Gender: male and female 3)ASA Class: 1, 2, 3 4)Patients posted for routine surgery, without any risk of aspiration or regurgitation requiring general anesthesia with orotracheal intubation 5)Duration of surgery less than 4 hours 6)Two or less than two attempts of intubation.
排除标准
- •Prone/lateral positioning for surgery 2)Recent history of upper respiratory tract infections; preoperative sore throat, hoarseness of voice or cough 3)Tracheostomised patients 4)Known airway anomalies (airway stenosis, including Down’s syndrome) 5)Known or suspected difficult intubation 6)Head and neck surgeries like surgery of the larynx and/or of the trachea, neck, and/or upper oesophagus 7)Pulmonary diseases (concurrent pneumonia or bronchial infection, asthma requiring inhalation medication, pulmonary malformations) 8)Fibre-optic intubation or alternative intubation technique 9)Planned postoperative ventilation in the ICU 10)Patients at risk of aspiration.
- •Pregnant patients, full stomach. 11)Anterior cervical spine surgeries. 12)Patients having hypotension (BP< 90 mm Hg) 13)Patients with BMI > 35 kg/m2.
结局指标
主要结局
Primary aim:
时间窗: 1. just after intubation | 2. at 30 mins | 3. at 1 hour | 4. at 2 hours | 5. at 3 hours | 6. at 4 hours/ just before extubation
1) To compare endotracheal cuff pressures obtained by- manual inflation of pilot balloon (by a syringe) and direct inflation via a cuff pressure gauge.
时间窗: 1. just after intubation | 2. at 30 mins | 3. at 1 hour | 4. at 2 hours | 5. at 3 hours | 6. at 4 hours/ just before extubation
2) To evaluate changes in cuff pressure over time.
时间窗: 1. just after intubation | 2. at 30 mins | 3. at 1 hour | 4. at 2 hours | 5. at 3 hours | 6. at 4 hours/ just before extubation
次要结局
- Secondary aim:(To assess complications like sore throat, hoarseness of voice, cough, post extubation stridor which may occur as a result of overinflated ETT cuff; aspiration which may occur as a result of insufficiently inflated cuff.)