A Prospective Randomised Controlled Study To Evaluate The Efficacy Of A Novel 3D Printed Facemask With An Integrated And Detachable Nasal Cannula For Providing Apneic Oxygenation By Assessing Arterial PartialPressure Of Oxygen During Larygoscopy And Intubation In Adult Patients Undergoing Surgical Procedures Under General Anaesthesia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The novel device will maintain higher PaO2 levels at the end of the apneic period compared to the conventional method, indicating better preservation of oxygen levels during the apneic phase.
研究概览
简要总结
Group A will undergo induction of anaesthesia with the novel 3D printed device
Group B will undergo induction of anesthesia with the conventional face mask with a separately attached nasal cannula and tubing.
Patients are preoxygenated for a period of 5 minutes with 8 litres/min of oxygen with either the conventional face mask and a separate nasal cannula connected t an independent oxygen source at 8 liters/ min of oxygen or a 3D printed face mask as per the group allotted. Induction is then done with Inj.Glycopyrolate 0.2mg IV, Inj.Midazolam 2 mg IV, Inj. Fentanyl 2microgms/Kg IV and Inj.Propofol 2mg/kg IV. after confirming adequacy of mask ventilation the patient is administered Inj.Atracurium 0.5mg/kg IVand mask ventilation continued for 3 min.
In group A the mask is removed while leaving the detachable nasal prongs in place to continue apneic oxygenation and laryngoscopy and intubation done. In group B conventional mask ventilation is done followed by laryngoscopy and intubationwhile leaving the nasal cannula in position for providing apneic oxygenation
Arterial blood would be collected at two time points, immediately before laryngoscopy i.e. the start of apneic period and again after intubation before delivery of the first breath i.e at the end of apneic period. Time duration of apneic period is noted.
The primary objective will be determined by the PaO2levels in the arterial blood at the start and end of the apneic period showing the degree of drop in the partial pressure of oxygen in the blood which will go towards proving the ability of the device to maintain the partial pressure of oxygen levels much higher than the conventional method of preoxygenation. The ability of the oxygen flow maintained during the apneic period should also be enough to provide some decrease in PaCo2 levels which can be quantified by the arterial blood gas analysis and will form the secondary outcome of the study along with the ease of mask ventilation as assessed by the 5 point Likerts scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients aged 18-50 years Scheduled for elective surgery requiring general anesthesia American Society of Anesthesiologists physical status classification I-III.
排除标准
- •Patients with anticipated difficult mask ventilation Nasal obstruction or recent nasal surgery.
- •Low oxygen saturation preoperatively Pre-existing pulmonary diseases Patient refusal to participate in the study.
结局指标
主要结局
The novel device will maintain higher PaO2 levels at the end of the apneic period compared to the conventional method, indicating better preservation of oxygen levels during the apneic phase.
时间窗: At baseline
次要结局
- We expect to prove that the novel device provides both good preoxygenation & apneic oxygenation with a single device.(The device will show a more effective reduction in PaCO2 levels during the apneic period than the conventional approach at baseline)