A prospective randomized study to compare standard versus reverseinsertion techniques of classic LMA in paediatric patients.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of attempts.
研究概览
简要总结
Title of this study isA prospective randomized study to compare standard versusreverse insertion techniques of classic LMA in paediatric patients. Laryngeal Mask Airway (LMA) is asupraglottic airway device that is designed to seal around the laryngeal inlet.It can be inserted into the pharynx to allow ventilation, oxygenation,and administration of anesthetic gases, without the need for endotrachealintubation. LMA is frequently used forairway management in paediatrics age group. LMA is a safer and reliablealternative rescue device in both elective and emergency situations for bothanticipated and unanticipated difficult airway. LMA is made from silicon andcontain no latex. It is a reusable device and may be steam autoclaved up to 40times.
Various methods and techniques have been described regarding theinsertion of LMA. The most primordial technique is standard technique ordigital technique. The another technique which is quite popular is reverse technique. In this study, we compared these two techniques of classic LMA insertion interms of insertion, Number of attempt, hemodynamic and overall success rate andincidence of complications if any. In this study we take all patientvisiting for surgery lessthan 60 minutes at UPUMS, Saifai(U.P.) Patients above 5year and less then 10 years of age.
Aim of this study to Compare of standardversus reverse insertion techniques of classic LMA in paediatric patients.
Obective of this study to evaluate and compare the ease of classicLMA insertion through the standard or reverse techniques with respect to number of attempts, Time to secure successful airway.
We will perform a prospectiverandomized study. In this study will wecompared two techniques of classic LMA insertion (Standard versus Reverse) interms of insertion, Number of attempt, hemodynamic and overall success rate andincidence of complications if any.
Outcome Measures of this study is to measures hemodynamic parameters HR, SBP,DBP,MAP,SPO2 in view of total numberof attempt and total time to secure successfulplacement of airway.
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
- 5.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •30 kg. 2.American society of anesthesiology (ASA) Physical status class I and class II. 3.Duration of surgery less than 60 minutes.
排除标准
- •1.Patients attendants refusing for participation.
- •2.Risk of aspiration (full stomach, gastroesophageal reflex disease,).
- •3.Inadequate mouth opening.
- •4.Any oral pathology.
- •5.Suspected difficult airway.
- •6.Surgery >60 minutes.
- •7.Age < 5 year or > 10 year.
- •8.Patients with any congenital anomaly.
- •9.Any emergency surgery.
结局指标
主要结局
Number of attempts.
时间窗: Base line, 1 min, 3 min, 5 min, there after every 5 min till successful airway is achieved.
Time to secure successful Airway.
时间窗: Base line, 1 min, 3 min, 5 min, there after every 5 min till successful airway is achieved.
次要结局
- Comparision of heamodynamic parameters.(Comparision of complication.)