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CTRI Number  CTRI/2024/03/064867 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 22/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to see the effect of stylet bending at respiratory tube holding position during insertion of respiratory tube using c mac video laryngoscope in adult patients posted for preplanned operations  
Scientific Title of Study   A prospective observational study to determine the efficacy of stylet angulation at the holding position during endotracheal intubation using c mac video laryngoscope in adults for elective surgery  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Merin Varghese 
Designation  Assistant Professor  
Affiliation  DR B R Ambedkar Medical College and Hospital  
Address  Department Of Anaesthesiology, DR B R Ambedkar Medical College and Hospital, KG Halli, Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  8547502337  
Fax    
Email  merinvv@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Merin Varghese 
Designation  Assistant Professor  
Affiliation  DR B R Ambedkar Medical College and Hospital  
Address  Department Of Anaesthesiology, DR B R Ambedkar Medical College and Hospital, KG Halli, Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  8547502337  
Fax    
Email  merinvv@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Merin Varghese 
Designation  Assistant Professor  
Affiliation  DR B R Ambedkar Medical College and Hospital  
Address  Department Of Anaesthesiology, DR B R Ambedkar Medical College and Hospital, KG Halli, Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  8547502337  
Fax    
Email  merinvv@gmail.com  
 
Source of Monetary or Material Support  
Dr B R Ambedkar Medical College and Hospital Bangalore  
 
Primary Sponsor  
Name  Dr Merin Varghese 
Address  Department of Anaesthesiology, DR B R Ambedkar Medical College and Hospital, Bangalore 
Type of Sponsor  Other [Self] 
 
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 Merin Varghese   DR B R Ambedkar Medical College and Hospital   Department of Anaesthesiology, OT complex, first floor,
Bangalore
KARNATAKA 
8547502337

merinvv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committee DR B R Ambedkar Medical College and Hospital  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  Angulated Stylet  Stylet angulation at holding position used for tracheal intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All the patients posted for elective surgeries under general anaesthesia with oro-tracheal intubation, Patients aged between 18-65 years of age, Patients belonging to American Society of Anaesthesiologists Physical Status (ASA-PS) I and II 
 
ExclusionCriteria 
Details  Patients with known predictors of difficult intubation, BMI more than 30kg/m2, Patients with previous history of difficult intubation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the time for successful placement of endotracheal tube  At baseline during laryngoscopy and endotracheal intubation  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the first pass success rate for tracheal intubation, Number of optimization manoeuvres required, Number of intubation attempts, Complications if any   At baseline from laryngoscopy till the successful placement of tracheal tube  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/04/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Airway management plays an essential role in anaesthesia practice during both elective and emergency surgeries. Endotracheal intubation considered to be the gold standard in securing the airway and definitive technique for resuscitation. It is commonly performed using direct laryngoscope.
Difficulties during routine intubation in the operating room occur in 1-6% of cases and intubation failure occurs in 0.1-0.3% of cases1. Over the last few years, video laryngoscopy based on the principles of indirect laryngoscopy have been introduced into clinical practice to ease endotracheal intubation and might be especially useful in less experienced providers like junior residents and paramedics. Video laryngoscopes are equipped with better illumination of light source and camera on the tip of the blade, enabling better visualization of the airway anatomy and ultimately making it easier to visualize the entrance of larynx. C-MAC video laryngoscope, initially designed primarily as a teaching tool,may be useful device in the clinical settings also as it can be used as a standard direct laryngoscope or as an indirect laryngoscope. When used as direct laryngoscope, it functions like any Macintosh laryngoscope 6. 
However, the good laryngeal view provided by the videolaryngoscopes does not always guarantee successful or easy intubation and it can be tricky and time consuming in emergency scenarios. Although gaining a view of the glottis is the easy part when using a video laryngoscope, tube delivery to the glottis is often difficult with a video laryngoscope because oral, pharyngeal and laryngeal axis are not aligned and thus the tip of the tube must pass around an acute angle to enter the larynx2. An intubating stylet is widely used to assist manipulation of the tube tip to allow necessary maneuverability to advance it beyond tation and might be especially useful in less experienced providers like junior residents and paramedics. Video laryngoscopes are equipped with better illumination of light source and camera on the tip of the blade, enabling better visualization of the airway anatomy and ultimately making it easier to visualize the entrance of larynx. C-MAC video laryngoscope, initially designed primarily as a teaching tool,may be useful device in the clinical settings also as it can be used as a standard direct laryngoscope or as an indirect laryngoscope. When used as direct laryngoscope, it functions like any Macintosh laryngoscope 6. 
However, the good laryngeal view provided by the videolaryngoscopes does not always guarantee successful or easy intubation and it can be tricky and time consuming in emergency scenarios. Although gaining a view of the glottis is the easy part when using a video laryngoscope, tube delivery to the glottis is often difficult with a video laryngoscope because oral, pharyngeal and laryngeal axis are not aligned and thus the tip of the tube must pass around an acute angle to enter the larynx2. An intubating stylet is widely used to assist manipulation of the tube tip to allow necessary maneuverability to advance it beyond the glottic opening into the trachea. When angulating a stylet in the sagittal plane at the operators holding position, the holding force of the right thumb is divided into vectors in a longitudinal direction and acts on the tip of the tracheal tube by using the index finger or middle finger as a fulcrum during the entire process of placement of the endotracheal tube. Therefore, the tube tip can be efficiently and precisely operated by finger movement that is suitable for fine manipulation1.  
There is knowledge lacunae whether angulating the stylet at holding position should be done routinely when performing tracheal intubation with C-MAC video laryngoscope6. Hence, in our study we would like to observe whether stylet angulation at the holding position would improve maneuverability of the tracheal tube and contribute to easy, smooth, and swift tube placement during endotracheal intubation using a C-MAC video laryngoscope.
 
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