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临床试验/CTRI/2023/02/049716
CTRI/2023/02/049716已完成4 期

Comparison of clinical performance of Laryngeal Mask Airway Protector versus Proseal Laryngeal Mask Airway for Bailey Manoeuvre A randomized control study

Department of Anaesthesia and Intensive Care1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年2月20日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
To compare the hemodynamic responses during extubation using Bailey‟s maneuver with Laryngeal Mask Airway Protector or Proseal LMA

研究概览

简要总结

Maintenance of a patent airway is an essential responsibility of anaesthesiologists. Extubation is equally significant as tracheal intubation in a general anaesthesia patient.Awake extubation is mostly considered as safest in anaesthetic practice but is associated with agitation which occurs as a consequence of movement of ETT against the vocal cords,this stimulus can result in tachycardia, coughing and hypertension which can be hazardous for patients especially of ENT surgery, patients with ischemic heart disease, aortic surgery.

The Bailey‟s maneuver is a technique for extubating patients in deeper plane of anaesthesia by substituting an oral endotracheal tube for a supraglottic airway device (SAD).This avoids coughing and bucking that is often undesired after certain surgical procedures.SAD has an added benefit of allowing flexible bronchoscope to assess for vocal cord mobility and laryngeal oedema

LMA Protector and LMA Proseal are SAD that can be used for performing Bailey,s Maneuver

Therefore, present study is planned to compare the clinical performance of LMA Protector™ and Proseal LMA™ for Bailey‟s maneuver during extubation.

It was decided to enroll a total of 100 subjects for the present trial for patient drop out and additional comparisons. Therefore, after the approval of protocol by the Hospital Ethics Committee, Clinical Trial Registry: India (CTRI) and obtaining informed consent from every patient, a total number of 100 patients admitted for elective surgery under general anaesthesia will be enrolled for the present study as per inclusion and exclusion criteria.

Patients will be evaluated preoperatively on the day prior to surgery,Written informed consent will be taken from all the patients enrolled for the study.Preoperative airway evaluation will be performed and routine investigation would be done for all patient.At the end of surgery,15 min prior to end of surgery, HR, BP, MAP, SPO2, ECG values will be recorded. At the end of surgery, when patient will be still under deep anaesthesia oropharyngeal suction will be done. At this moment SAD will be inserted behind the ETT and its cuff will be inflated.Fibreoptic bronchoscope will be inserted via the airway tube of LMA Protector or Proseal LMA to grade the adequate placement of the device. The grading will be noted. Then HR, BP, MAP, ECG and SPO2 values will be recorded; after SAD is inserted; after removal of ETT and continued at 1,2,3,5 and 10 minutes afterwardsAfter completion of surgery,SAD will be removed HR, BP, MAP, ECG and SPO2 will be recorded immediately after removal of SAD and 1,2,3,5 and 10 minutes afterwards. • The cough reflex and awakening after extubation will be observed • Any adverse effects such as bleeding, trauma or sore throat, if any, will be noted in postoperative room till first 24 hours post operatively (Once in post operative room and once after 24 hours of removal of SAD).

All the patient will be transferred to post operative care unit (PACU) for observation before shifting them to respective post operative wards.

All the observations will be noted in prescribed proforma

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
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

  • Age group of 18 to 60 years
  • ASA (American Society of Anaesthesiologists) status I and II
  • Patients undergoing elective surgery requiring general anaesthesia with endotracheal intubation.

排除标准

  • Patients with difficult airway with Airway difficulty score>8
  • Morbid obesity BMI > 35 kg/m2
  • Known airway pathology
  • Oropharyngeal surgeries
  • Surgery more than 3 hours
  • Patients at increased risk of aspiration like gastroesophageal reflux, peptic ulcer
  • Previous upper gastrointestinal surgery
  • Known or anticipated difficult tracheal intubation or facemask ventilation
  • Coagulopathy or history of anticoagulant use
  • Cardio respiratory or cerebrovascular disease
  • Cervical spine injury
  • Pregnant Patients.

结局指标

主要结局

To compare the hemodynamic responses during extubation using Bailey‟s maneuver with Laryngeal Mask Airway Protector or Proseal LMA

时间窗: Hemodynamic response would be noted After SAD insertion,after remoal of ETT,1,2,3,5and 10 min afterward and then at SAD removal and 1,2,3,5 and 10 min afterward

次要结局

  • 1) To compare secondary parameters such as cough reflex awakening after extubation using Bailey‟s maneuver with Laryngeal Mask Airway Protector device or Proseal LMA.(2) To observe any adverse effects such as bleeding, trauma or sore throat, if any.)

研究者

发起方
Department of Anaesthesia and Intensive Care
申办方类型
Government medical college

研究点 (1)

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