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临床试验/CTRI/2025/08/092318
CTRI/2025/08/092318尚未招募不适用

Comparative evaluation of McCoy and CMAC D-Blade laryngoscope for rapid sequence intubation in patients with simulated restricted neck mobility

Department of Anaesthesia and Intensive care GMCH Chandigarh1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年8月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
110
试验地点
1
主要终点
To compare the time taken for endotracheal intubation with the McCoy and CMAC D-Blade laryngoscope using rapid sequence intubation technique in patients with simulated restricted neck mobility.

研究概览

简要总结

This study compares endotracheal intubation time using the CMAC D Blade videolaryngoscope and McCoy laryngoscope during Rapid Sequence Intubation (RSI) with Manual In Line Stabilization (MILS) in patients with restricted neck mobility. Endotracheal intubation is crucial for airway management, but cervical immobilization disrupts optimal positioning , which complicates laryngoscopy . While the CMAC D Blade offers enhanced glottic visualization without  requirement of alignment of oral , oropharyngeal and laryngeal axis ; the levering mechanism of McCoy laryngoscope may improve Cormack Lehane grades. RSI, involving cricoid pressure (Sellicks maneuver), which further challenges intubation by obscuring the view. Existing studies show conflicting results on intubation times between these devices, with some favoring CMAC D Blade and others favour McCoy . This study hypothesizes that the McCoy laryngoscope will enable faster intubation due to direct line of sight and reduced hand eye coordination demands compared to the CMAC D Blade. The findings aim to guide optimal device selection in patients with restricted neck mobility , balancing speed and success to minimize hypoxemia and aspiration risks during emergency intubation.

Aims :

To compare McCoy and CMAC D-Blade laryngoscope for rapid sequence intubation in patients with simulated restricted neck mobility .

Objective :

·       To compare the time taken for endotracheal intubation with the McCoy and CMAC D Blade laryngoscope using rapid sequence intubation technique in patients with simulated restricted neck mobility.

·       To compare the glottic view (Modified Cormack Lehane grading and POGO score), duration of laryngoscopy to obtain the glottic view, total duration for endotracheal intubation and first attempt success rate of endotracheal intubation with the two with the McCoy and CMAC D Blade laryngoscope using rapid sequence intubation technique in patients with simulated restricted neck mobility. devices.

·       To compare the hemodynamic parameters in patients undergoing tracheal intubation and post operative adverse events with the two devices.

Following observations will be recorded in all the patients:

1.     Time taken for laryngoscopy (TL) : Time between introduction of device till the clear view of glottis

2.     Time taken for endotracheal intubation (TI) : Time between clear laryngeal view to appearance of first capnography waveform.

3.     Total time taken for intubation (TTI) from introduction of device in mouth till first square wave capnograph is obtained

4.     The number of attempts until the tube is in tracheal, as confirmed by capnography and chest auscultation.

5.     Laryngeal view obtained (Modified Cormack and Lehane grading and Percentage of Glottis Opening (POGO) score by the airway manager.

6.     Heart rate (HR), NIBP, SpO2 and ETCO2 will be monitored continuously throughout the procedure and recorded just before intubation, immediately after intubation, at 1 minute after intubation, 5 minutes after  intubation and 10 minutes after intubation.

7.     Any other intra operative finding:

a)     Broken Teeth

b)    Soft tissue oedema

c)     Bleeding from gums/lips

8.     Postoperative observations: All patients will be evaluated in the post anaesthesia care unit (PACU) and in the ward for a duration of 12 hours for the following observations:

a)     Sore throat

b)    Stridor/hoarseness

c)     Any other complication

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Age group of 18 to 60 years of either gender.
  • 2.Patients with the American Society of Anaesthesiologists (ASA) physical status Class I and II.
  • 3.Patients undergoing elective surgery requiring endotracheal intubation under general anaesthesia.

排除标准

  • 1.Patients with anticipated difficult airway [Airway Difficulty Score (ADS)more than 8] 2.Morbid obesity (BMI more than 35kg per meter square).
  • 3.Pregnant women.
  • 4.Major maxilla facial trauma or cervical spine pathology.
  • 5.Severe cardiorespiratory, cerebrovascular, renal, lymphatic and musculoskeletal diseases.
  • 6.Severe coagulopathy or history of anticoagulant use.
  • 7.Patients at increased risk of pulmonary aspiration such as gastroesophageal reflux disease (GERD), peptic ulcer disease.
  • 8.Surgeries in prone position.

结局指标

主要结局

To compare the time taken for endotracheal intubation with the McCoy and CMAC D-Blade laryngoscope using rapid sequence intubation technique in patients with simulated restricted neck mobility.

时间窗: Time between clear laryngeal view to appearance of first square wave capnograph is obtained .

次要结局

  • To compare Time taken for laryngoscopy .(Time between introduction of device in mouth till the clear view of glottis is obtained)
  • To compare the Total time taken for intubation(Time from introduction of device in mouth till first square wave capnograph is obtained)
  • To compare the number of attempts for successful intubation(Number of attempts taken till first square wave capnograph is obtained .)
  • To compare the laryngeal view obtained(after obtaining clear laryngeal view during laryngoscopy)
  • To compare hemodynamic parameters(To compare hemodynamic parameters preoperatively,just before insertion, immediately after insertion, 1 minute, 5 minutes & 10 minutes after intubation)
  • Any other complications-(soft tissue oedema , dental trauma, bleeding from gums/ lips .)
  • Post operative Complications such as sore throat, stridor or hoarseness(Complications such as sore throat, stridor or hoarseness to be noted after extubation for 12 hours .)

研究者

发起方
Department of Anaesthesia and Intensive care GMCH Chandigarh
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Rahul Joshi

Government Medical College and Hospital, Sector 32, Chandigarh

研究点 (1)

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