A COMPARATIVE STUDY BETWEEN NEW AIRWAY AIRWAY SECURING DEVICES TO OTHER AIRWAY SECURING DEVICE IN PATIENT WITH NORMAL AIRWAY WHO ARE BEING UNDERGOING FOR ELECTIVE OPERATION.
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2021/08/035862
- Lead Sponsor
- All India Institute of Medical Sciences Patna
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 204
- ASA I and ASA II BMI.
- <30 Kg/m2 Posted for elective surgery in routine operation theatre.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To measure ease of intubation in three attempts 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
- Secondary Outcome Measures
Name Time Method 1.TIME OF INTUBATION 2.NUMBER OF ATTEMPTS
Trial Locations
- Locations (1)
ALL INDIA INSTITUTE OF MEDICAL SCIENCES PATNA
🇮🇳Patna, BIHAR, India
ALL INDIA INSTITUTE OF MEDICAL SCIENCES PATNA🇮🇳Patna, BIHAR, IndiaDr BABLI KUMARIPrincipal investigator08709193564bbk.babli@gmail.com