Comparative Study Between VolumeControlled Ventilation and FlowControlled Ventilation Through Ultra-thin Tube in Upper Airway Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Measurement of dynamic chest wall compliance (mL/mbar)
研究概览
简要总结
Ventilation through the small endotracheal tube is not an uncommon situation. The indications for it differ from elective upper airway surgery to emergency ventilation through needle cricothyrotomy. Conventionally, ventilation through small endotracheal tubes has been challenging by jet ventilation with subsequent risk of barotrauma and inadequate gas exchange. Expiration during jet ventilation occurs passively.
详细描述
Upper airway endoscopy (micro laryngoscopy (MLS), pan endoscopy) is a minor upper airway procedure needing short duration general anesthesia, small calibrate endotracheal tube and manipulation of the airway. Because of airway manipulation and the surgery involves the airway, which is being shared with the anesthesiologist, there is a risk of interruption of ventilation, oxygenation and loss of airway in addition to inherent complications of surgery.
Methods:
After the patients will receive information about the study and informed consent will be taken. The patients will be randomized. In the control group, (group A) ventilation will be performed according to the routine big endotracheal tube. In the treatment group (group B), the ultra-thin ventilation tube will be placed using laryngoscopy. All other treatment will be unchanged. Data collection will be started 5 min after the initiation of the study. Demographic data, Past medical history, and examinations data will be collected after acceptance of the patient to be enrolled into the study and other ventilation parameters will be collected 5 min after the start of the the study which is Skin incision Primary endpoint is; to evaluate whether the Flow Controlled Ventilation (FCV) can also achieve adequate oxygenation and ventilation through small tube or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult population of both sex (ASA I, II).
- •Between18-65 years of age.
- •Patients for the upper airway.
- •Patients need intubation/invasive mechanical ventilation.
排除标准
- •Advanced Respiratory disease.
- •Advanced cardiovascular disease.
- •Pregnancy.
- •Recent upper airway trauma.
- •Age less than 18 years or more than 65 years.
- •Patients BMI of more than 35
- •Refuse to sign the consent.
研究组 & 干预措施
Standard care: Control (Group A)
Patients who are scheduled for elective surgical upper airway surgery will be given General Anesthesia by an anesthesiologist who is the principal investigator and the surgical procedures will be done by the same ENT surgeon. IV Induction of Anesthesia with Propofol Target controlled infusion (TCI), Remifentanil Target controlled infusion (TCI) and Rocuronium (0.5mg/Kg) for muscle relaxation. The airway will be secured with cuffed endotracheal tube after direct laryngoscopy. After intubation by a Suitable size Endotracheal tube, they will be mechanically ventilated using Volume Controlled Ventilation (VCV) with 40% Oxygen and minute ventilation adjusted to keep ETCO2 of 40 mmHg or less, and a PEEP of 5 cmH2O.
Intervention Group: (Group B)
General Anesthesia will be induced with IV Induction of Anesthesia by an anesthesiologist with Propofol (Target controlled infusion), Remifentanil (Target controlled infusion), and Rocuronium (0.5mg/Kg) for muscle relaxation. The airway will be secured with cuffed Tritube after direct laryngoscopy. They will be mechanically ventilated using Flow Controlled Ventilation (FCV) with 40% Oxygen, Flow rate:13L/Min., Peak Airway Pressure (15 cmH2O), and a PEEP of (5 cmH2O) to keep ETCO2 of 40 mmHg or less. The anesthesia will be maintained with Intravenous Infusion of Propofol, Remifentanil (TCI) to keep BIS 40-60.
干预措施: Flow Controlled Ventilation (Device)
结局指标
主要结局
Measurement of dynamic chest wall compliance (mL/mbar)
时间窗: During study time intra-operatively
Dynamic chest wall compliance changes due to Flow Controlled Ventilation (FCV) in comparison to routine Volume Controlled Ventilation(VCV)
Airway Resistance (mbar*s/L)
时间窗: During procedure time and intra-operatively
This measures the airway resistance changes due to Flow Controlled Ventilation (FCV) in comparison to the traditional Volume Controlled Ventilation(VCV)
次要结局
- Oxygen concentration (SPaO2)and tension(PaO2) in the blood (% and mmHg respectively)(Intra-operatively during procedure time)
- Carbon dioxide in the blood (PaCO2) and the trachea (ECO2) mmHg.(During surgical procedure intra-operatively)
- Postoperative sore throat according the Visual Analogue Scale (VAS)(After surgical procedure (2 and 24) hours.)
- Kink of the small size tube (Tritube) (Yes/No)(During surgical procedure)
- Surgeon satisfaction instance scale (1-5)(During surgical procedure)