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临床试验/CTRI/2024/05/066825
CTRI/2024/05/066825尚未招募4 期

Comparison of AirtraqTM videolaryngoscope with Macintosh laryngoscope for emergency endotracheal intubation: A randomized controlled study

University College Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年5月30日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
70
试验地点
1
主要终点
To study and compare the time to intubation between Airtraq TM video laryngoscope and direct Macintosh laryngoscope

研究概览

简要总结

Study title: Evaluation of AirtraqTM video laryngoscope with Macintosh laryngoscope for emergency endotracheal intubation in adult patients: A randomized controlled study.

Rationale: Securing the airway timely and safely is of prime importance and thus a laryngoscope which offers this benefit over a Macintosh laryngoscope would be a suitable addition in scenarios requiring emergency endotracheal intubations.

Aim: To study and compare of AirtraqTM video laryngoscope with Macintosh laryngoscope for emergency endotracheal intubation in adult patients

Objectives:

Primary Objective: Comparison of time to successful intubation between Airtraq TM videolaryngoscope and Macintosh laryngoscope.

Secondary objectives: To study and compare the following:

1.     First pass intubation success rates between Airtraq TM and Macintosh laryngoscope.

2.     Cormack- Lehane assessment for the glottis view by both the Airtraq TM videolaryngoscope and Macintosh laryngoscope.

3.     Number of attempts for successful endotracheal intubation with both

Airtraq TM and Macintosh laryngoscope.

4.     Ease of intubation with either device using a three point scoring system of good, satisfactory and poor based on visualization of glottis, need of manipulations to aid intubation, and success at the first attempt at intubation

5.     Incidence of esophageal intubation, failed intubation (one in which trachea cannot be intubated with the chosen laryngoscope by 2 attempts and the third attempt will be made with a change of device or one which took >120 seconds) and dental trauma.

Place of study: The proposed study will be conducted in Department of Anaesthesiology and Critical Care, University College of Medical Sciences & Guru Teg Bahadur Hospital, Delhi.

Study period: The duration of study will be from April 2024 to August 2025.

Study design: Randomised controlled study.

Sample size:  patients in each group, total 70 patients.

Patient selection:

Inclusion criteria:

A total of 70 (35 in each group) consenting adult patients between the ages of 18-70 years requiring emergency endotracheal intubation in the hospital premises by a team of anaesthesiologists.

Exclusion criteria:

1.     Endotracheal intubations performed in the operating room

2.     Endotracheal intubations performed in the intensive care unit

3.     Patients in whom surgical airway will be required as the first option to secure a definite airway

Randomization, group allocation: Computer generated random number table and sealed opaque for allocation concealment

Group A: Intubation using Airtarq TM laryngoscope.

Group M: Intubation using Macintosh direct laryngoscope

Statistical Analysis:

•                Data will be coded and recorded in MS Excel spreadsheet program. SPSS v23 (IBM Corp.) will be used for data analysis.

•                Descriptive statistics will be elaborated in the form of means/standard deviations and medians/IQRs for continuous variables, and frequencies and percentages for categorical variables.

•                Group comparisons for continuously distributed data will be made using independent sample ‘t’ test when comparing two groups. If data will be found to be non-normally distributed, appropriate non-parametric tests in the form of Wilcoxon Test will be used for these comparisons.

•                Statistical significance will be kept at p < 0.05

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Adult patients between the ages of 18-70 years requiring emergency endotracheal intubation in the hospital premises by a team of anaesthesiologists.

排除标准

  • Endotracheal intubations performed in the operating room Endotracheal intubations performed in the intensive care unit Patients in whom surgical airway will be required as the first option to secure a definite airway.

结局指标

主要结局

To study and compare the time to intubation between Airtraq TM video laryngoscope and direct Macintosh laryngoscope

时间窗: The time of intubation

次要结局

  • To compare the first pass intubation success rates between Airtraq TM & Macintosh laryngoscope.(Comparison of the Cormack- Lehane assessment for the glottis view by both the Airtraq TM videolaryngoscope & Macintosh laryngoscope.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Abhimanyu Kumar Singh

University College of Medical Sciences/Guru Tegh Bahadur Hospital

研究点 (1)

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