Awake Endotracheal Intubation With Glidescope Video Assisted Laryngoscope vs Fiberoptic Bronchoscope in Patients With Traumatic Cervical Injury; Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- intubating time
研究概览
简要总结
The researcher will compare awake endotracheal intubation with glidescope video assisted laryngoscope vs fiberoptic bronchoscope in patients with traumatic cervical injury;
详细描述
One hundred patients undergoing post traumatic cervical spine fixation under general anesthesia will be randomly allocated to two groups in a prospective study. Between December 2022 and May 2023.
All patients will be premedicated before the procedure and after giving 500 ml of lactated ringer solution with glycopyrrolate 0.2 mg iv and dexmedetomidine 1 mic/kg IV over 10 minutes then 0.4 mic/kg/h continuous IV infusion. All patients will receive standard clinical care monitoring including three lead ECG, noninvasive arterial blood pressure measurement and pulse oximeter. Patient will be administered oxygen 6 L/min through nasal prong.
Patients will be allocated into two equal groups (50 patients per group) for awake intubation with either FOB (F group) or GVL (G group) according to computer generated randomization technique. Each patient will receive nebulization with 5 ml of lidocaine 1% for 5 min followed by topicalization of soft palate and fauces with 5 puffs of lidocaine spray (10 mg/spray) immediately before the technique of endotracheal intubation (ID 6.5 mm for female and 7 mm in male, armored tube. Before airway manipulation each patient will receive a bolus dose of fentanil 1 mic/kg.
During the procedure Philadelphia cervical collar will be removed and MILS of cervical spine will be carried out by trained assistant (senior registrar anesthetist, 5 years' experience). After successful intubation (by consultant anesthesia who had more than 100 times successful intubation with either FOB or GVL) and neurological assessment (by spinal surgeon), general anesthesia will be induced with propofol 1.5 mg/kg, cisatracurium 0.1 mg/kg and remifentanil 0.5 lg/kg. Hypotension (decreased in MAPP 20% of base line) will be treated with ephedrine bolus 5-10 mg and 250 ml of lactated ringer solution. Only three attempts will be permitted per each patient and if failed plan B was to carry out endotracheal intubation under inhalational induction with FOB without neuromuscular blockade and to exclude patients from the study. Attempt will be held if O2 saturation decreased below 90%.
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
- None
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
- 否
入选标准
- •ASA I-II patients
- •ages 26-44
- •undergoing a selective cervical spine fixation.
排除标准
- •body mass index (BMI) more than 35 kg/m
- •Obstructive airway disease
- •cardiovascular disease
- •apparent airway difficulty
- •patient refusal .
研究组 & 干预措施
Awake Fiberoptic bronchoscope
Awake endotracheal intubation of cervical trauma patients by Fiberoptic bronchoscope
干预措施: sedative (Drug)
Awake Glidoscope Videolaryngoscope
Awake endotracheal intubation of cervical trauma patients by Glidoscope Videolaryngoscope
干预措施: sedative (Drug)
Awake Glidoscope Videolaryngoscope
Awake endotracheal intubation of cervical trauma patients by Glidoscope Videolaryngoscope
干预措施: Awake endotracheal intubation by Glidescope videolaryngoscope (Device)
Awake Fiberoptic bronchoscope
Awake endotracheal intubation of cervical trauma patients by Fiberoptic bronchoscope
干预措施: Awake endotracheal intubation by Fiberoptic bronchoscope (Device)
结局指标
主要结局
intubating time
时间窗: immediately post endotracheal intubation
(defined as the time from introduction of the scope till confirmation of correct endotracheal tube placement with three waves endtidal capnography)
intubating attempts
时间窗: immediately post endotracheal intubation
intubating attempts per each patient (will be recorded by dedicated technician).
次要结局
- patient satisfaction (score; excellent =1, good =2 and fair = 3).(immediately post endotracheal intubation)
- heart rate(immediately post endotracheal intubation)
- mean arterial blood pressure(immediately post endotracheal intubation)
研究者
Mona Mohamed Mogahed
Associate professor
Tanta University
