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CTRI Number  CTRI/2024/05/067270 [Registered on: 14/05/2024] Trial Registered Prospectively
Last Modified On: 27/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two kind of blade of video laryngoscope for endotracheal intubation 
Scientific Title of Study   Comparison of Channeled versus non-Channeled blade of video laryngoscope for emergency endotracheal intubation: A randomized clinical study. 
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 Sangeeta Sahoo 
Designation  Additional professor 
Affiliation  AIIMS Bhubaneswar 
Address  Room no.-342 Academic block AIIMS Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9556547655  
Fax    
Email  drsangeeta.asth@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sangeeta Sahoo 
Designation  Additional professor 
Affiliation  AIIMS Bhubaneswar 
Address  Room no.-342 Academic block AIIMS Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9556547655  
Fax    
Email  drsangeeta.asth@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shiny  
Designation  Junior Resident 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Trauma and Emergency AIIMS Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9959100118  
Fax    
Email  shinyjaladi1999@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Bhubaneswar Orissa,India PIN-751019  
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  AIIMS Bhubaneswar,Orissa PIN-751019 
Type of Sponsor  Government medical college 
 
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 SHINY JALADI  All India Institute of Medical Sciences, Bhubaneswar  Emergency Room Department of Trauma and Emergency
Khordha
ORISSA 
9959100118

shinyjaladi1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE (Registration No. ECR/534/Inst/OD/2014/RR-20 All India Institute of Medical Sciences Bhubaneswar  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  Channel blade of video laryngoscope;  For group NCB, intubations Will be performed using Non-Chanell blade of video Laryngoscope. Anaesthesia induction before intubation will be carried with etomidate 0.2–0.3 mg/kg preceded by three minutes of pre oxygenation with 100% oxygen. Rapid sequence intubation (RSI) will be done by 30 seconds after succinylcholine with a dose of 1.5 mg/kg. This process will be commenced by post-graduate emergency medicine student with at least six months of experience in various intubation. The definition of intubation attempt will be defined if any insertion of laryngoscope enters beyond the level of teeth, disregarding of successful outcome. A successful try of intubation termed with equal chest rise on both side and bilateral chest auscultation with stethoscope. The time measured from the point of insertion of laryngoscope blade to mouth till the confirmation of correct placement of the tube into the vocal cord will be regarded as time needed to perform tracheal intubation. Hypotension will be termed as when systolic blood pressure lesser than 100 mmHg, and brady cardia when heart rate lesser than 60 beats per minute Hypoxia will be defined when saturation of oxygen showing in pulse manometry or in Monitor lower than 93% at any point starting from pre oxygenation time till 15-min post intubation.  
Comparator Agent  Non-Channel blade of video laryngoscope;  Patients will be divided on random basis into two groups by using computer generated random codes. For group NCB, intubations Will be performed using Non-Channel blade of video Laryngoscope. Anaesthesia induction before intubation will be carried with etomidate 0.2–0.3 mg/kg preceded by three minutes of pre oxygenation with 100% oxygen. Rapid sequence intubation (RSI) will be done by 30 seconds after succinylcholine with a dose of 1.5 mg/kg. This process will be commenced by post-graduate emergency medicine student with at least six months of experience in various intubation. The definition of intubation attempt will be defined if any insertion of laryngoscope enters beyond the level of teeth, disregarding of successful outcome. A successful try of intubation termed with equal chest rise on both side and bilateral chest auscultation with stethoscope. The time measured from the point of insertion of laryngoscope blade to mouth till the confirmation of correct placement of the tube into the vocal cord will be regarded as time needed to perform tracheal intubation. Hypotension will be termed as when systolic blood pressure lesser than 100 mmHg, and brady cardia when heart rate lesser than 60 beats per minute Hypoxia will be defined when saturation of oxygen showing in pulse manometry or in Monitor lower than 93% at any point starting from pre oxygenation time till 15-min post intubation.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Critically ill patients requiring emergency intubation on arrival. 
 
ExclusionCriteria 
Details  1.cardiac arrest intubations
2.hyperkalaemia
3.burn and crush injuries
4.Pregnant patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be time to endotracheal intubation.   At baseline, 1 minute,2minutes,5 minutes, 10 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes include, success rate of intubation in first attempt and incidence of esophageal intubation and airway related complications like blood in the oral cavity, dental trauma.  At baseline, 1 minute,2minutes,5 minutes, 10 minutes 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   25/06/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Endotracheal Intubation is a life-saving procedure performed in emergency departments (EDs) across the globe. Under some circumstances, it has been found that; it seems pretty much impossible to align the axes, making direct visualization of the laryngeal inlet difficult or impossible with direct laryngoscopy and there by proving it to be a futile one. But the most detrimental part of this we lose a patient due to unnecessary delay in intubation. So, these cases present as a particularly challenging situation for emergency physicians and there what the video laryngoscopes does come into action. The faster intubation time escalating the ease of intubation in video laryngoscopes. The first pass success rate of video intubation rely on cumulative factors i.e blade size, blade type, design, structural configurations, angulation of blade (obtuse /acute. It is generally accepted that using a video laryngoscope is associated with an improved visualization of the glottis. However, correctly placing the endotracheal tube might be challenging. Channelled video laryngoscopy blades have an endotracheal tube already pre-loaded, allowing to advance the tube once the glottis is visualized. We hypothesized that use of a channel blade with pre-loaded endotracheal tube results in a faster intubation, compared to a curved Macintosh blade video laryngoscope. To our knowledge, no randomized controlled study has examined the relative performance of Chanell blade with that non-Chanell blade of video laryngoscope in emergency set up for tracheal intubation. The aim of the study was to compare the emergency tracheal intubation performances of the video laryngoscope non channelled blade with that Chanell blade in the emergency department.       

 
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