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临床试验/NCT02403414
NCT02403414Unknown不适用

Assessment of Airway in Patients With Acromegaly Undergoing Surgery: Predicting Successful Tracheal Intubation

All India Institute of Medical Sciences, New Delhi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年3月最近更新:
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
Successful tracheal intubation

研究概览

简要总结

Acromegaly is associated with increased risk of difficult intubation and its management. The overall incidence of difficult intubation in patients suffering from acromegaly is four to five times more than those without acromegaly.The difficult intubation scenario in these patients can be managed by various methods ranging from awake fiberoptic intubation to tracheostomy. Difficult tracheal intubation accounts for 17% of respiratory-related injuries and results in significant morbidity and mortality in general population. In patients with acromegaly, inability to mask ventilate or intubate can lead to 28% of all anesthesia related deaths. Therefore, the need and importance of airway assessment in patients with acromegaly cannot be overemphasized. Various tests of airway assessment have to be used to assess difficult airway and tracheal intubation in acromegalics.

The investigators aim to assess the various tests of airway assessment affecting the outcome of patients with acromegaly undergoing pituitary surgery and identify which was best suited.

详细描述

All the patients of either gender, diagnosed as a case of acromegaly scheduled for pituitary surgery will be enrolled. This observational study will be conducted over a period of 3 years. A written informed consent will be taken from all the patients. The clinical diagnosis will be made on the basis of growth hormone (GH) levels and magnetic resonance imaging (MRI) findings. All patients will be evaluated preoperatively, a day before surgery by an independent observer. Airway assessment for difficult intubation will be performed using Modified Mallampati classification in sitting and supine position followed by mouth opening, upper lip bite test, measurement of thyromental, thyrohyoid, sternomental and hyomental distance. Next the length of upper incisors, presence of receding mandible and neck movement will be checked. An associated history of OSA will also be taken in to account for assessing the difficult intubation followed by OSA grading in acromegalic patients posted for pituitary surgery. In situation of difficult tracheal intubation the fiberoptic intubation would be the preferred choice, which is a gold standard.

General anesthesia will be induced with fentanyl 2µg/kg, propofol 2 mg/kg and rocuronium 1mg/kg. After 90 seconds of mask ventilation, laryngoscopy will be performed with an appropriate sized Macintosh laryngoscope and thereafter Cormac lehane grading will be noted. External laryngeal manipulation (ELM) if carried out will be noted. A standard anesthesia protocol will be followed. After completion of the surgery, neuromuscular blockade will be reversed with neostigmine 0.05mg/kg and glycopyrrolate 0.01mg/kg intravenously. Once the patient follows the verbal command and respiratory parameters are satisfactory, endotracheal tube will be removed. All patients will be shifted to neurosurgical ICU for observation and supportive management.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Acromegalic patients undergoing surgery

排除标准

  • 未提供

结局指标

主要结局

Successful tracheal intubation

时间窗: 10 minutes

次要结局

  • Rate of complications(24 hours)

研究者

发起方
All India Institute of Medical Sciences, New Delhi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Indu Kapoor

Doctor

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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