Comparison of two hand C-E with hybrid mask ventilation techniques by novice airway providers in adult patients under general anaesthesia
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 2 minutes or 24 breaths mean exahaled tidal volume in both groups
研究概览
简要总结
The study will be conducted following approval from the Institutional Ethical and Scientific Review Committee. All enrolled patients will undergo a routine pre-anesthetic checkup, including medical history, physical examination, and airway assessment. Adequate fasting status will be ensured, and informed written consent will be obtained in a language understood by the patient.Participants will be randomly assigned to one of two groups (Group A or B) using computer-generated randomization, with group assignments concealed in sequentially numbered opaque envelopes.Upon arrival in the operating room, standard monitoring (pulse oximetry, 5-lead ECG, and non-invasive blood pressure) will be initiated, and baseline parameters including heart rate, systolic and diastolic blood pressure, and oxygen saturation will be recorded.An intravenous line will be secured, and premedication with IV midazolam (0.05 mg/kg) will be administered. Each patient will receive pre-oxygenation with 100 percent oxygen at 10 L/min for 3 minutes using a well-fitting transparent face mask.General anesthesia will be induced using IV propofol (2 mg/kg), IV fentanyl (2 mcg/kg), and IV vecuronium (0.1 mg/kg). Mechanical ventilation will be set in pressure-controlled mode (peak pressure 15 cm H2O, no PEEP, 12 breaths per minute, I:E ratio 1:2).A consultant anesthesiologist will perform mask ventilation for the first minute to confirm adequacy, then hand over to a novice airway provider (less than 3 years of experience) for 2 minutes of ventilation using the allocated technique—either two-hand C-E or hybrid (dominant hand C-E and non-dominant hand thenar eminence). An independent observer will record parameters such as exhaled tidal volume and oxygen saturation.If oxygen saturation drops below 94 percent or there is any hemodynamic instability, the consultant anesthesiologist will intervene immediately to ensure patient safety. After the study period, the anesthesiologist will proceed with standard care.Study Aim is to compare the effectiveness of the two-hand C-E technique and the hybrid mask ventilation technique when performed by novice airway providers in adult patients under general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA class I and II Patients posted for elective surgery under general anaesthesia Modified Mallampti grade I and II.
排除标准
- •Patients which predictors of difficult mask ventilation that is edentulous, beard, history of snoring, old age, BMI greater than 30.
结局指标
主要结局
2 minutes or 24 breaths mean exahaled tidal volume in both groups
时间窗: 2 minutes or 24 breaths mean exahaled tidal volume in both groups
次要结局
- Number of failed breaths reflected by no exhaled tidal volume & operator comfort based on 5 point likert scale(Total no of failed breaths at one minute two minutes & three minutes from baseline)
研究者
Dr Payal Pandya
ABVIMS and Dr RML hospital New Delhi
