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临床试验/CTRI/2025/08/093050
CTRI/2025/08/093050尚未招募4 期

Influence of different head and neck positions on oropharyngeal leak pressure with laryngeal mask airway protector in elective surgeries

Government Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Comparing the difference in oropharyngeal leak pressure with changes in head and neck positions using the LMA Protector airway device

研究概览

简要总结

Airway management has evolved considerably over the past decade, primarily due to advancements in Supraglottic Airway Devices These devices provide a significant alternative in general anesthesia for situations where tracheal intubation poses challenges, facilitating ventilation and oxygenation. It is particularly beneficial in emergency situations and for patients with anatomically complex airways.SADs are generally categorized into first and second generation devices. First generation equipments include the use of a basic airway pipes such as the laryngeal mask airway  without features aimed at minimizing aspiration. Second generation, like the ProSeal LMA, I-gel and LMA Protector contains more newer features like gastric drainage port and epiglottis blockers which both improve safety and efficiency. The effectiveness of supraglottic airway devices particularly their ability to maintain a proper seal can depend on head movements. Flexing neck decreases anteroposterior diameter of pharynx by relieving anterior pharyngeal muscle tension, while extending the neck increases this diameter.Most supraglottic airway devices are designed to be inserted gently into oropharynx to create a reliable seal, ensuring consistent ventilation. Ongoing clinical research evaluating the LMA Protector have indicated that it allows for straightforward insertion and achieves superior oropharyngeal leak pressures relative to other routinely utilised devices. We hypothesize that laryngeal mask airway protector achieves superior OLP in flexion head position.

AIM

To observe the Influence of different head and neck positions on oropharyngeal leak pressure with Laryngeal Mask Airway Protector airway in elective surgeries

PRIMARY OBJECTIVE:

Comparing the difference in oropharyngeal leak pressure with changes in head and neck positions using the LMA Protector airway device

SECONDARY OBJECTIVE:

To study the insertion time of LMA Protector

To study the number of attempt required for insertion

To study the ease of insertion of the deviceTo study hemodynamic variations in different head and neck positions

To study fiberoptic assessment of glottic view through the device. To study post-operative complications such as sore throat, stridor or hoarseness, dental

trauma, any other relevant complications.

METHODOLOGY

The study protocol outlines thorough pre anaesthesia workup including physical examinations and various test and assessment of dufficult airway.patients will be advised fasting and will be premedicated accordingly.During anaesthesia standard procedures will be followed,including preoxygenation,induction with propofol,and neuromuscular blockade.After insertion of LMA,monitoring parameters are measured. mode. Hemodynamic parameters [HR (heart rate), ECG, NIBP,SpO2 and End Tidal Carbon dioxide will be monitored and recorded with every head positions.After the end of surgery and reversal from anaesthetic agents, the study device will be removed and the incidence of blood stain on the device will be recorded.

Following observations will be recorded in all the patients:

  1. OLP in cm of water, in neutral, flexion, extension, right lateral and left lateral position of head and neck

  2. Time taken for SAD insertion

  3. Ease of insertion of SAD. The ease of insertion of device will be graded.

  4. Number of attempts for successful SAD insertion.

  5. Fibreoptic grading of the laryngeal view through the study device.

  6. Any adverse events during the procedure like oxygen desaturation, soft tissue or dentaltrauma, blood stain on device.

  7. Degree of postoperative sore throat

  8. Intraoperative hemodynamic parameters HR, NIBP,oxygen saturation end-tidal carbondioxide level preoperatively, before and after insertion, in all head positions.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with American society of anaesthesiologist physical status grade 1 and 2 2.age between 18-70 3.patients undergoing elective surgeries requiring controlled ventilation under general anaesthesia.

排除标准

  • Patients with anticipated difficult airway Airway Difficulty Score
  • Morbid obesity
  • Pregnant women
  • Major maxilla-facial trauma or cervical spine pathology
  • Severe cardiorespiratory, cerebrovascular, renal, hepatic or musculoskeletal diseases
  • Severe coagulopathy or history of anticoagulant use
  • Patients at increased risk of pulmonary aspiration such as gastroesophageal reflux disease, peptic ulcer disease, full stomach
  • Surgery in prone position.

结局指标

主要结局

Comparing the difference in oropharyngeal leak pressure with changes in head and neck positions using the LMA Protector airway device

时间窗: After induction and 5minutes after neutral head position,5minutes after flexion head position,5minutes after extension head position,5minutes after right lateral position and 5minutes after left lateral head position.

次要结局

  • 1.To study the insertion time of LMA Protector(2.To study the number of attempt required for insertion)

研究者

发起方
Government Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Praveen kumar S

Government Medical College and Hospital,Chandigarh

研究点 (1)

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