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临床试验/CTRI/2022/09/045549
CTRI/2022/09/045549已完成不适用

Comparison of efficacy of intubation with Hugemed non channeled video laryngoscope, McCoy and Macintosh laryngoscope in simulated difficulty laryngoscopy using rigid cervical collar-a prospective randomized trial.

Mysore Medical College and research Institute1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年9月19日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Primary objective is to assess intubation difficulty score. Also time taken for intubation was assessed.

研究概览

简要总结

Securing the airway is very essential during general anesthesia procedure. There are many laryngoscopic blade for the same. In our study we will compare a newer videolaryngoscopic blade- Hugemed videolaryngoscopic blade with  Maccoy and the conventional Machintosh blade. Hence there will be three groups with 50 patients in each group. After obtaining the informed consent, we will conduct the study in patients posted for surgery under general anesthesia needing endotracheal intubation meeting the other inclusion criteria as mentioned. Computer based randomised will be done. We will try to simulate the difficult airway by using the rigid cervical collar which will restrict the neck extension , just before the intubation. We will use premedications , inducing agent propofol and vecuronium as mescle relaxants. Anesthesia will be maintained by nitrous oxide and volatile agents. intubation will be attempted by trained anesthesiologist. When intubation is attempted depending on the group, the intubation difficulty score as described by Adnet et al. and time taken for intubation will be noted as our primary objective states. We will also note the difficulty in laryngoscopic blade insertion and any complications as our secondary objective states. data will be collected in preformed proforma. Blinding of the participant and data analyser can be done. But blinding of the investigator will be difficult to be maintained.

Further the patient will be monitored throughout the surgery and reversed and then extubated. Any adverse effect or complications during this period will be noticed. Statistical data will be analysed using SPSS software 28.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor 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

  • Patients posted for surgery under general anesthesia will be included with American Society of Anesthesiology (ASA) grade I or II, having body mass index (BMI) less than 25-35kg/m2 having Mallampatti grade of 1 or 2.

排除标准

  • age less than 18 years and more than 60 years obese patients difficult airway.

结局指标

主要结局

Primary objective is to assess intubation difficulty score. Also time taken for intubation was assessed.

时间窗: baseline, 1 minute, 3 minutes, 5 minutes and 10 minutes

次要结局

  • Secondary objectives are to assess ease of laryngoscope blade insertion into the oral cavity and detect if there are any complications(baseline, 1 minute, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 9 hours, 24 hours)

研究者

发起方
Mysore Medical College and research Institute
申办方类型
Government medical college

研究点 (1)

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