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临床试验/NCT05619965
NCT05619965尚未招募不适用

Awake Endotracheal Intubation With Glidescope Video Assisted Laryngoscope vs Fiberoptic Bronchoscope in Patients With Traumatic Cervical Injury; Randomized Controlled Trial

Tanta University0 个研究点目标入组 100 人开始时间: 2022年12月1日最近更新:
适应症
干预措施

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

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

Active Comparator

Awake endotracheal intubation of cervical trauma patients by Fiberoptic bronchoscope

干预措施: sedative (Drug)

Awake Glidoscope Videolaryngoscope

Active Comparator

Awake endotracheal intubation of cervical trauma patients by Glidoscope Videolaryngoscope

干预措施: sedative (Drug)

Awake Glidoscope Videolaryngoscope

Active Comparator

Awake endotracheal intubation of cervical trauma patients by Glidoscope Videolaryngoscope

干预措施: Awake endotracheal intubation by Glidescope videolaryngoscope (Device)

Awake Fiberoptic bronchoscope

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mona Mohamed Mogahed

Associate professor

Tanta University

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