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临床试验/NCT04509960
NCT04509960Unknown不适用

Comparison of Airway Placement Conditions and Postoperative Effects of Laryngoscope-guided Laryngeal Mask Placement Methods in Sniffing Position in Geriatric Edentulous Patients

Ankara Diskapi Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年1月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
laryngeal mask placement

研究概览

简要总结

different ways of airway management in elective minor surgeries of geriatric patients

详细描述

The investigators will used two different ways of pro-seal laryngeal mask insertion technique (laryngoscopy- guided technique or the standard technique) in elective minor surgeries of geriatric toothless patients.

The investigators will record the respiratory dynamics, heartbeat, systolic, diastolic, mean arterial pressures every 5 minutes during surgery. The investigators will record the laryngeal mask insertion time and oropharyngeal leakage pressure. The investigators will evaluate the placement of a laryngeal mask according to young criteria. The development and severity of coughing, retching, laryngospasm, extremity, and head movement during laryngeal mask placement will be recorded. Bloodstains, sore throat, hoarseness will be recorded on the mask that may develop due to laryngeal mask placement. The investigators will use the Briacombe scoring and Campbell category system to assess the position of laryngeal mask airway devices.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status I or II or III
  • Who were scheduled to minor elective ambulatory surgery (e.g. urology operations)
  • Patients undergoing general anesthesia
  • Those who are planned to wear a laryngeal mask for surgical procedure

排除标准

  • patients with full stomach
  • A history of gastric reflux
  • A history of convulsions, cardiovascular or neuromuscular disease
  • Allergies to the study drugs
  • obese (Body mass index (BMI) ≥ 40 kg / m2)
  • suspected difficult airway and hyper-reactive airway disease

结局指标

主要结局

laryngeal mask placement

时间窗: First minute after laryngeal mask insertio

To evaluate the best fiberoptic bronchoscopic view while insertion of pro-Seal laryngeal mask either in a classic way, or with the help of laryngoscope. The fibreoptic evaluation Includes 4, only vocal cords visible; 3, vocal cords plus posterior epiglottis visible 2, vocal cords plus anterior epiglottis visible ; 1, vocal cords not seen.

complications of laryngeal mask insertion

时间窗: Complications will be evaluated within 1 hour after patient recovery.

complications like sore throat, hoarseness, nausea, and vomiting or Bloodstain on the laryngeal mask. we simply asked patients about them

次要结局

  • hemodynamic response(Before putting on the Layngeal mask, it will record in beats / minute at 5 minutes for 1 minute and 20 minutes after wearing)
  • hemodynamic responce(Before putting on the Layngeal mask, it will record in mm Hg at 5 minutes for 1 minute and 20 minutes after wearing)
  • oxygen saturation(Before putting on the Layngeal mask, it will record in %SpO2 at 5 minutes for 1 minute and 20 minutes after wearing)
  • insertion time(The investigator will record the insertion time in seconds from the moment the laryngeal mask airway passes the incisors until the end-tidal CO2 is visible.)
  • respiratory dynamics(The first minute after the laryngeal mask insertion, and every 5 minutes thereafter up to the 20th minute)

研究者

发起方
Ankara Diskapi Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Filiz Akaslan

specialist

Ankara Diskapi Training and Research Hospital

研究点 (1)

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