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CTRI Number  CTRI/2021/08/035862 [Registered on: 24/08/2021] Trial Registered Prospectively
Last Modified On: 19/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   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. 
Scientific Title of Study   A comparative study of intubation parameters between Blockbuster LMA and C-MAC video laryngoscope in a patient with normal airway undergoing elective surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  BABLI KUMARI 
Designation  POST GRADUATE STUDENT  
Affiliation  AIIMS Patna 
Address  IPD BUILDING FIFTH FLOOR A BLOCK DEPARTMENT OF ANAESTHESIOLOGY AIIMS PATNA AURANGABAD ROAD PHULWARISHARIF PATNA
IPD BUILDING FIFTH FLOOR A BLOCK DEPARTMENT OF ANAESTHESIOLOGY AIIMS PATNA AURANGABAD ROAD PHULWARISHARIF PATNA 801505
Patna
BIHAR
801505
India 
Phone  08709193564  
Fax    
Email  bbk.babli@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR UMESH KUMAR BHADANI 
Designation  PROFESSOR AND HEAD 
Affiliation  AIIMS PATNA 
Address  DEPARTMENT OF ANAESTHESIOLOGY, AIIMS PATNA AURANGABAD ROAD PHULWARISHARIF PATNA
DEPARTMENT OF ANAESTHESIOLOGY, AIIMS PATNA AURANGABAD ROAD PHULWARISHARIF PATNA 801505
Patna
BIHAR
801507
India 
Phone  8969169123  
Fax    
Email  umeshbhadani@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR UMESH KUMAR BHADANI 
Designation  PROFESSOR AND HEAD OF DEPARTMENT OF ANAESTHESIOLOGY 
Affiliation  AIIMS PATNA 
Address  DEPARTMENT OF ANAESTHESIOLOGY, AIIMS PATNA AURANGABAD ROAD PHULWARISHARIF PATNA
DEPARTMENT OF ANAESTHESIOLOGY, AIIMS PATNA AURANGABAD ROAD PHULWARISHARIF PATNA 801505
Patna
BIHAR
801507
India 
Phone  8969169123  
Fax    
Email  umeshbhadani@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES PATNA 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Patna 
Address  AIIMS Patna Aurangabad road Phulwarisharif Patna Bihar 801505 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr BABLI KUMARI  ALL INDIA INSTITUTE OF MEDICAL SCIENCES PATNA  IPD BUILDING, A BLOCK OT COMPLEX FIFTH FLOOR DEPARTMENT OF ANAESTHESIOLOGY ALL INDIA INSTITUTE OF MEDICAL SCIENCES PATNA AURANGABAD ROAD PHULWARI SHARIF PATNA
Patna
BIHAR 		 08709193564

bbk.babli@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BLOCKBUSTER LMA   INTUBATION WILL BE DONE INTRAOPERATIVELY AND TIME DURATION OF INSERTION , NUMBER OF ATTEMPTS AND ANY POST OPERATIVE COMPLICATION WILL BE ASSESSED 
Comparator Agent  C MAC VIDEOLARYNGOSCOPE   INTUBATION WILL BE DONE INTRAOPERATIVELY, TIME DURATION OF INSERTION, NUMBER OF ATTEMPTS AND POSTOPERATIVE COMPLICATION WILL BE ASSESSED  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  ASA I and ASA II

BMI - <30 Kg/m2

Posted for elective surgery in routine operation theatre
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
1.TIME OF INTUBATION
2.NUMBER OF ATTEMPTS
3. For Post operative complication
 		 1.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
2.3 attempts will be considered as failed intubation
3
a. Sore throat before shifting from recovery room and after 24 hours
b.By presence of blood stain in endotracheal tube just after extubation 
 
Target Sample Size   Total Sample Size="204"
Sample Size from India="204" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/08/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="9" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [bbk.babli@gmail.com].

  6. For how long will this data be available start date provided 25-08-2021 and end date provided 22-07-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
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





 
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