A Prospective, Open-label, Multicenter, Post Marketing, Observational Study to Investigate the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 主要终点
- Percentage of Participants With Successful Intubation (Clinical Success)
研究概览
简要总结
The purpose of this study was to record the effectiveness of sevoflurane for intubation in Egyptian, non-obstetric, difficult to intubate (DTI) patients undergoing surgery in regards to the rate of intubation success.
详细描述
This is a prospective, open-label, multicenter, post marketing, observational study to investigate the effectiveness of sevoflurane anaesthesia in difficult to intubate (DTI; Mallampati Score III or IV) Egyptian patients who had been prescribed sevoflurane for anaesthesia by their treating physician.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female over 18 years who are undergoing surgery and using sevoflurane as the anesthetic agent and with Mallampati score III or IV
- •Patients with at least one of the below criteria:
- •micrognathia - small mandible
- •macroglossia - large tongue
- •short or fixed neck
- •anterior vocal cords
- •Trauma - neck or face
- •Burns - airway edema
- •Infections - edema
- •Retropharyngeal abscess
- •Submandibular abscess
- •epiglottitis
- •laryngotracheobronchitis (croup)
- •Neoplasms; e.g., laryngeal tumors
- •Rheumatoid arthritis - temporomandibular joint (TMJ) immobility
- •Diabetes mellitus
- •Waxy skin - palm test
- •Decreased functional residual capacity (FRC) - rapid desaturation (due to displaced diaphragm, increased closing capacity and small airway closure, increased oxygen consumption)
- •airway closure in supine position
- •Morbid obesity (body mass index [BMI] >35)
- •Airway edema
- •Laryngospasm
- •Edentulous patients - indent cheeks.
- •Patients willing to sign informed consent
排除标准
- •Patients with present use of opioids and/or narcotic dependent.
- •Patients with known sensitivity to sevoflurane or to other halogenated agents.
- •Patients with known or suspected genetic susceptibility to malignant hyperthermia.
- •Alcohol addictive patients.
- •Patients with Renal insufficiency (baseline serum creatinine greater than 1.5 mg/dL)
- •Patient is a pregnant or breastfeeding female
结局指标
主要结局
Percentage of Participants With Successful Intubation (Clinical Success)
时间窗: Start of intubation to completion of intubation (up to 15 minutes)
Participants were considered to have a successful intubation if intubation was achieved in less than 4 separate intubation attempts according to the guidelines of the American Society of Anesthesiologists (ASA). The number of intubation attempts was a maximum of 3 attempts, after which the intubation was considered a failure.
次要结局
- Mean Duration of Induction (in Seconds)(From start of induction up to 15 minutes)
- Percentage of Participants With Mallampati Score III and IV(Screening)
- Mean Duration of Intubation Procedure (in Minutes)(Start of intubation to completion of intubation (up to 15 minutes))
- Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure(Start of intubation to completion of intubation (up to 15 minutes))
- Percentage of Participants Who Experienced Difficulties Related to the Use of Sevoflurane(From start of induction to completion of intubation (up to 30 minutes))
- Mean Number of Intubation Attempts(Start of intubation to completion of intubation (up to 15 minutes))