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临床试验/CTRI/2021/08/035862
CTRI/2021/08/035862尚未招募不适用

A comparative study of intubation parameters between Blockbuster LMA and C-MAC video laryngoscope in a patient with normal airway undergoing elective surgery

All India Institute of Medical Sciences Patna1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2021年8月27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
204
试验地点
1
主要终点
1.To measure ease of intubation in three attempts

研究概览

简要总结

A Comparative study of intubation  parameters  between  Blockbuster LMA and C-MAC video laryngoscope in a patient with normal airway undergoing Elective surgery

Endotracheal intubation is placement of endotracheal tube into the trachea as a conduit for ventilation. With the new advancement in medical science and after discovery of inhalational anaesthetic agent and muscle relaxant that facilitated different surgical procedures to be conducted easily by securing of airway and controlled ventilation which require endotracheal intubation.

´The goal of the surgeon is to perform surgery efficiently, comfortably and safely.

´The purpose of Anaesthesia is to provide optimum surgical condition with maximum safety. Intubation is a potentially life-saving maneuver  both in routine and emergency situation and there have been many advances in management of airway in anaesthesia.

´In this study, two of commonly used equipments dealing with endotracheal intubation is compared i.e

´ comaparision of Blockbuster LMA (a type of SGA) and Video laryngoscope for different parameters of ease and success of endotracheal intubation, total time taken for intubation, number of attempts and post operative complication related to intubation

AIM:-

To compare the ease and success of endotracheal intubation by using Blockbuster LMA and C-MAC video laryngoscope in patient undergoing Elective surgery

            OBJECTIVE

PRIMARY OBJECTIVE:-

a)To estimate the success rate of Blockbuster LMA and C-MAC Video laryngoscope, whether they facilitate and improve the tracheal intubation in three attempts.

SECONDARY OBJECTIVE:-

a)To evaluate the number of attempts taken and time taken for successful intubation and,

b)To observe any post operative complication eg sore throat, blood stain just after extubation  in endotracheal tube from either equipments.

RESEARCH QUESTION

a)Whether  Blockbuster LMA and C-MAC video laryngoscope is suitable for endotracheal intubation?

b)Is any one of them is superior to other?

METHODOLOGY

Study design:- Randomised controlled  trial study

Study Participants :- Healthy patients posted for elective surgery

INCLUSION CRITERIA                                                                                                           EXCLUSION CRITERIA

ASA I and II                                                                                                                                 ASA III and IV

Either sex                                                                                                                                      Age :- <18 years and >55 years

Age – 18 – 55 years                                                                                                                      Mallampati grade III and IV

Mallampati grade I and II                                                                                                             BMI more than 30 Kg/m2

BMI - <30 Kg/m2                                                                                                                         Any obstructive airway pathology andcervical spine abnormality, restricted neck movement

Posted for elective surgery in routine operation theatre                                                               Gastroesophageal reflux

Patient not giving consent for study

Sampling population: The cases posted for routine elective surgery under General anesthesia fitting in inclusion criteria during the study period.

Sample size:- 204

SAMPLING TECHNIQUE :- computer generated list of random numbers.

´                    CONCEALMENT - sealed opaque envelope  technique.

´                    BLINDING:- Patient and postoperative study person is  blinded for the type of equipment used for endotracheal intubation.

Patients will be intubated by either equipment by  randomly dividing patients in two groups ,102each GROUP A – C – MAC Videolaryngoscope and GROUP B -    Blockbuster LMA

OUTCOMES

  1. To measure ease of intubation in three attempt

GRADE 1 :- intubation with no resistance in one attempt in airway tract

GRADE 2:- intubation with 1 external manipulation to larynx

GRADE 3:- intubation with >1 external manipulation to larynx

GRADE 4:- <3 attempts for intubation with external manipulation with or without use of adjuncts .

GRADE 5 :- > 3 attempt for intubation with external manipulation to larynx with the use of adjuncts.

GRADE 6:- Other technique used for intubation after failed attempts or intubation done by experienced anaesthetic

TIME OF INTUBATION:- It will be defined as time interval between holding the airway device to confirmation of correct placement by square wave capnogram appearance will be noted. It will be recorded in seconds

.NUMBER OF ATTEMPTS :- >3 attempts will be considered as failed intubation

For Post operative complication a. Sore throat:- YES OR NO

BLOOD STAINING IN ET TUBE AFTER EXTUBATION :- YES/ NO By presence of blood stain in endotracheal tube just after extubation

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 55.00 Year(s)(—)
性别
All

入选标准

  • ASA I and ASA II BMI.
  • <30 Kg/m2 Posted for elective surgery in routine operation theatre.

排除标准

  • ASA III and IV Gastroesophageal reflux Age <18 and >55 years Mallampatti grading III , IV Any obstructive airway pathology andcervical spine abnormality, restricted neck movement Patient not giving consent for study.

结局指标

主要结局

1.To measure ease of intubation in three attempts

时间窗: by grading | 1-intubation with no resistance in one attempt in airway tract | 2- intubation with 1 external manipulation to larynx | 3- intubation with 1 external manipulation to larynx | 4- 3 attempts for intubation with external manipulation with or without use of adjuncts . | 5 - 3 attempt for intubation with external manipulation to larynx with the use of adjuncts | 6:-Other technique used for intubation after failed attempts or intubation done | by experienced anaesthetics

次要结局

  • 1.TIME OF INTUBATION(2.NUMBER OF ATTEMPTS)

研究者

发起方
All India Institute of Medical Sciences Patna
申办方类型
Research institution and hospital

研究点 (1)

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