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CTRI Number  CTRI/2024/07/071245 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 24/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the first attempt success rate of pre-shaped bougie with stylet for insertion of airway tube in trachea with special blade( C-MAC D Blade) of videolaryngoscope in patients posted for elective surgery by head held in neutral position. 
Scientific Title of Study   Comparison between pre-shaped bougie versus stylet used for intubation with C-MAC D-blade videolaryngoscope in simulated difficult airway:A randomised control trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lavanya ruba malini 
Designation  Junior Resident 
Affiliation  AIIMS PATNA 
Address  Department of Anaesthesiology, OT Complex, IPD Building, 5TH Floor, AIIMS Patna, Phulwarisharif, Patna.

Patna
BIHAR
801507
India 
Phone  7762897656  
Fax    
Email  lavanyadharmar98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr kunal singh 
Designation  Additional Professor 
Affiliation  AIIMS PATNA 
Address  room no 501, Department of Anaesthesiology, OT Complex, IPD Building, 5TH Floor, AIIMS Patna, Phulwarisharif, Patna.

Patna
BIHAR
801507
India 
Phone  9411514945  
Fax    
Email  drsinghkunal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr kunal singh 
Designation  Additional Professor 
Affiliation  AIIMS PATNA 
Address  room no 501, Department of Anaesthesiology, OT Complex, IPD Building, 5TH Floor, AIIMS Patna, Phulwarisharif, Patna.

Patna
BIHAR
801507
India 
Phone  9411514945  
Fax    
Email  drsinghkunal@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology,All India Institute of Medical sciences,Patna,Phulwari sharif, PIN-801507 
 
Primary Sponsor  
Name  All india institute of medical sciences,Patna 
Address  Department of Anaesthesiology, OT Complex,5th floor,IPD Building,AIIMS Patna,Phulwarisharif,Patna,Bihar,Pin:801507,India 
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 Lavanya ruba malini  All India Institute of Medical Sciences ,Patna  Department of Anaesthesiology, OT, OT Complex, 5th floor,IPD Building, Patna, Bihar.
Patna
BIHAR 
7762897656

lavanyadharmar98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Patna  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  pre-shaped bougie  General anaesthesia will be induced by Inj.Fentanyl 2mcg/kg, Inj.Propofol 2 to 2.5mg/kg and after checking ventilation Inj.Atracurium o.5mg/kg will be adminstered.Patients will be held in manual in line stabilisation.Laryngoscopy will be done by C-MAC D-blade videolaryngoscope and then pre-shaped bougie will be used for endotracheal tube placement not exceeding 60 seconds. Endotracheal tube placement will be confirmed by capnography. 
Comparator Agent  stylet  General anaesthesia will be induced by Inj.Fentanyl 2mcg/kg, Inj.Propofol 2 to 2.5mg/kg and after checking ventilation Inj.Atracurium o.5mg /kg will be adminstered.Patients will be held in manual in line stabilisation.Laryngoscopy will be done by C-MAC D-blade videolaryngoscope and then stylet will be used for endotracheal tube placement not exceeding 60 seconds. Endotracheal tube placement will be confirmed by capnography. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients planned for elective surgeries under GA
ASA 1 and 2
BMI:18-35 
 
ExclusionCriteria 
Details  ASA 3 and 4
BMI more than 35
Pregnant women
Increased risk of regurgitation and aspiration of gastric contents
Previous upper gastrointestinal surgery
History of coagulopathy or anticoagulant use
cardiorespiratory or cerebrovascular disease
cervical spine pathology

 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the successful intubation on the first attempt achieved with pre-shaped bougie or stylet as adjuncts to the C-MAC D-blade videolaryngoscope in a simulated difficult airway  From insertion of C-MAC D-blade till the conformation of endotracheal tube, not exceeding 60 seconds 
 
Secondary Outcome  
Outcome  TimePoints 
Modified intubation difficulty score will be assessed.
To evaluate the time taken with pre-shaped bougie & stylet in intubation with C-MAC D-blade videolaryngoscope,
To check cormack-lehane grading.
To assess the hemodynamics response. 
To evaluate the time duration from insertion of C-MAC D-blade till conformation of endotracheal tube , not exceeding 60 seconds. 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
Final Enrollment numbers achieved (Total)= "170"
Final Enrollment numbers achieved (India)="170" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/08/2024 
Date of Study Completion (India) 31/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Healthcare professionals encounter substantial difficulties when dealing with intubating patients with a challenging airway condition.This complexity arises from a variety of factors such as anatomical irregularities, limited mouth opening or distorted airway structures all of which obstruct a clear view and hinder tracheal access during intubation. For critically ill adults undergoing emergency tracheal intubation, failure to intubate the trachea on the first attempt occurs in upto 20% of the cases and is associated with severe hypoxemia and cardiac arrest. Videolaryngoscope has emerged as a vital method for this purpose, offering  a clearer view of laryngeal inlet. However, even with this improved visibility, successfully guiding the tube into the trachea remains persistent challenge. Adjucts like bougie and stylet are used in conjunction with video laryngoscopes to enhance the success rate.This study aims to evaluate and compare the effectiveness of using pre-shaped bougie and stylet as adjuncts with C-MAC D-Blade video laryngoscope in achieving successful intubation in simulated difficult airway. The number of attempts taken to intubate weighs heavily on the patient outcome. Hence,we would like to take this study and find out whether pre-shaped bougie increase the incidence of successful intubation on first attempt in simulated difficult airway.

 
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