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临床试验/NCT06447818
NCT06447818招募中不适用

Changes in Difficult Airway Markers After Surgery for Obstructive Sleep Apnoea Syndrome

Kocaeli City Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
42
试验地点
1
主要终点
Change of Modified mallampati score

研究概览

简要总结

This study investigates the changes in difficult airway markers at 6 months post operatively in patients undergoing obstructive sleep apnoea surgery

详细描述

The incidence of difficult airway is approximately one in 1000 cases and it is a life-threatening condition in perioperative patients. Many classifications, guidelines and appæroaches have been proposed to recognise patients with difficult airway. Even the most well-known classifications are not 100% successful in predicting difficult airway . For this reason, some unexpected difficult airway cases are encountered and their management is the subject of new research in the literature .

Obstructive sleep apnoea syndrome (OSAS) is associated with the possibility of difficult airway. Perioperative airway complications may also increase in patients with OSAS. Complications related with cardiac, pulmonary, endocrine and other systems are observed in patients living with a diagnosis of OSAS for a long time. The rate of complications is increased especially in patients with prolonged apnoea episodes during sleep.Anaesthesia process also poses a risk for OSAS patients. In patients receiving positive airway pressure therapy at home, intensive care or close anaesthesia is required at the end of the operation.follow-up is applied. In addition, OSAS patients are suitable candidates for day surgery, which is increasing day by day.

Reducing the symptoms with surgical treatment before OSAS is complicated can also reduce the effects that may occur in the future. Surgeries such as anterior uvulopalatinoplasty are frequently performed in these patients. OSAS patients require close follow-up and evaluation in terms of anaesthesia before these surgeries. A decrease in symptoms after surgery has been shown in some publications.Our study will be conducted in prospective observational status. Within the study period (01.05.2024-01.05.2025), patients who will undergo OSAS surgery by the ENT clinic in our operating theatres in a 12-month period will be included. In the preoperative evaluation of these patients; STOP-BANG and Epworth sleepiness test, SF-12 quality of life scales and laboratory values, if any, echocardiography results will be collected.

Weight, mallampati scores, neck circumference, thyromental distances and demographic data will be recorded at the preoperative visit.

After induction of anaesthesia, parameters such as mask ventilation, difficulty in laryngoscopy and intubation, Cormack-Lehane scores on direct laryngoscopy and the need for advanced airway techniques will be recorded.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18-65
  • American society of assosication score (ASA) :1-3
  • To undergo Obstructive sleep apnea surgery (OSAS)

排除标准

  • Verbal and written consent cannot be obtained

结局指标

主要结局

Change of Modified mallampati score

时间窗: post operative sixth month

Modified mallampati score is one of the difficult airway markers evaluated preoperatively When the mouth is opened and the tongue is protruded Grade 1:soft palate, uvula, plicae and tonsils are clearly visible Grade 2:The soft palate, uvula, plicae and upper pole of the tonsils are visible. Grade 3: only the soft palate and part of the palate can be seen. Grade 4:only the hard palate can be seen.

次要结局

  • Change of Cormack lahane score(post operative sixth month)
  • Sleep quality assesment pre and post operative surgery(post operative sixth month)

研究者

发起方
Kocaeli City Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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