Efficacy of the new LMA Gastro Airway as an Airway device in patients undergoing Endoscopic procedures under General Anaesthesia: a single centre observational study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- The primary outcome is to look at the percentage of Successful placement of LMA Gastro, which is defined as, Tidal volumes more than or equal to 4ml per kg, No peak pressures more than 30 cm of H2O and a good EtCo2 waveform in the range of 28 to 30
研究概览
简要总结
The Laryngeal mask airway, a supraglottic airway device, over the years has gained popularity in various settings like, management of difficult airway, cardiopulmonary resuscitation and non operating room anesthesia. With the advancement of interventional endoscopic procedures, the gastroenterology suite is a growing area for non operating room anesthesia as the practice is inclining more towards deep sedation / general anesthesia rather than conscious sedation. Though general anesthesia is the choice in practice, the need for a safer, fast and gentle airway device is necessary.
LMA Gastro is a new 2nd generation supraglottic airway device which is specially designed for Upper Gastrointestinal endoscopy. It comes with dedicated channel for insertion of endoscope with an internal diameter of 14mm and a separate channel for ventilation parallel to it. The endoscopy port ends at the distal tip of the cuff in such a way that it aligns itself to the upper esophageal opening. It also comes with an integrated cuff pressure indicator to monitor the cuff pressure and an adjustable holder with strap to prevent any displacement or dislodgement of the tube. The advantage of LMA Gastro over other SAD is that it facilitates esophageal intubation without compromising the airway and positive pressure ventilation.
All ASA1 and ASA2 patients who are posted for elective gastroscopic procedures requiring General anesthesia, after taking an informed consent, will be included in this study. Patient refusal, patients with ASA>= 3, with anticipated difficult airway, high risk of aspiration( morbid obesity BMI > 40), GERD , Cardiac diseases, Airway anomalies, Emergency Gastroscopic procedures will be excluded from the study. All the patients will be recruited by the primary investigator and advised fasting for solids from 12 midnight and clear fluids from 5am. After securing a good intravenous (IV) access and connecting all ASA standard monitors, the patient will be sedated with IV Propofol, following which LMA Gastro will be introduced.
The criteria for successful placement of LMA Gastro are:
i)Tidal volumes >/= 4ml/kg
ii) No peak pressure elevation >30 cm H2o
iii)Good EtCo2 waveform in the range of 28-30
iv)Not >/= 3 attempts and bilaterally equal chest rise.
Other parameters such as the hemodynamics, saturation, the time taken to wake up the patient and shift to recovery and any occurrence of laryngospasm, airway obstruction or requirement of airway manipulations after removal of LMA Gastro will be monitored during the procedure. In Recovery/Post Anesthesia Care Unit (PACU) patient will be evaluated for any hoarseness in voice or sore throat. The incidence of these parameters will be analyzed and thereby the efficacy of LMA Gastro for Gastroscopic procedures will be evaluated.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 10.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •All American Society of Anesthesiologists (ASA) 1and 2 patients who will require Upper GI Endoscopic procedure under General Anesthesia and have consented to participate in the study.
排除标准
- •Patients who refuse to consent
- •ASA 3 and above
- •Anticipated difficult airway
- •High risk of aspiration
- •Cardiac diseases
- •Airway anomalies
- •Emergency endoscopic procedures.
结局指标
主要结局
The primary outcome is to look at the percentage of Successful placement of LMA Gastro, which is defined as, Tidal volumes more than or equal to 4ml per kg, No peak pressures more than 30 cm of H2O and a good EtCo2 waveform in the range of 28 to 30
时间窗: Intraoperative period ,approximately 30mins to 1 hour
次要结局
- Incidence of hemodynamic Instability(Intraoperative period, approximately 30mins to 1 hour)
- Incidence of airway compromise(Intraoperative period, approximately 30mins to 1 hour)
- Incidence of laryngospasm(Intraoperative period, approximately 30mins to 1 hour)
- Incidence of post procedural Sore throat(30mins after completion of procedure)
