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CTRI Number  CTRI/2018/03/012627 [Registered on: 16/03/2018] Trial Registered Retrospectively
Last Modified On: 13/03/2018
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 blood pressure and heart rate response while passing tube into the windpipe using two different instruments 
Scientific Title of Study   Comparison of haemodynamic responses to orotracheal intubation in anaesthetised and paralysed patients with simulated cervical spine injury: Airtraq® video laryngoscope versus Fibreoptic bronchoscope 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manu G 
Designation  Junior Resident 
Affiliation  Kasturba medical college 
Address  Department of Anaesthesia

Udupi
KARNATAKA
576104
India 
Phone  8660231618  
Fax    
Email  manuvenmanakkal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ajith 
Designation  Assistant Professor 
Affiliation  Kasturba Medical college 
Address  Department Of Anaesthesia, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9663590183  
Fax    
Email  ajithonline07@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shiyad M 
Designation  Assistant Professor 
Affiliation  Kasturba Medical college 
Address  Department of Anaesthesia, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8050903635  
Fax    
Email  shiyad82@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College,Manipal Academy of higher education, Manipal, Udupi, Karnataka 576104 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Manipal Academy of Higher Education, Manipal, Udupi, Karnataka. 576104 
Type of Sponsor  Private 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 
Manu G  Kasturba Medical college  Department of Anaesthesia, Main OT complex, Manipal
Udupi
KARNATAKA 		 8660231618

manuvenmanakkal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients posted for elective surgery ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group A  Intubation was done using Airtraq® video laryngoscope 
Intervention  Group F  Intubation was done using Fibreoptic bronchoscope 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients in 18 to 60 year age group scheduled for elective surgery under
general anaesthesia requiring tracheal intubation
2. ASA PS I and II
 
 
ExclusionCriteria 
Details  1.Anticipated difficult airway
2.Signs and symptoms of raised intracranial pressure
3.Head injury
4.Cervical spine disease
5.BMI > 30 kg/m²
Risk of gastric aspiration
Reactive airway disease
Patients on drugs affecting blood pressure or heart rate
Systolic blood pressure > 140 mmHg and diastolic blood pressure > 90
mmHg
Heart rate > 100 beats per minute 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare haemodynamic changes to orotracheal intubation with Airtraq®
video laryngoscope and Fibreoptic bronchoscope in anaesthetised and paralysed
patients with simulated cervical spine injury with respect to the following
parameters:
1. Heart rate (HR)
2. Systolic blood pressure (SBP)
3. Diastolic blood pressure (DBP)
4. Mean arterial blood pressure (MAP) 		 Time in seconds from introduction of Airtraq® video laryngoscope or Fibreoptic bronchoscope into the mouth to the time of confirmation of endotracheal tube placement by appearance of capnographic trace 
 
Secondary Outcome  
Outcome  TimePoints 
duration of intubation  Time in seconds from introduction of Airtraq® video laryngoscope or Fibreoptic bronchoscope into the mouth to the time of confirmation of endotracheal tube placement by appearance of capnographic trace 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2016 
Date of Study Completion (India) 25/12/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 25/12/2017 
Estimated Duration of Trial   Years="1"
Months="10"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published in any national or international journals 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Aim of my study was to compare haemodynamic changes to orotracheal intubation with Airtraq videolaryngocope and fibreoptic bronchoscope with respect to systolic blood pressure, diastolic blood pressure, mean systolic blood pressure and Heart rate. Patients were randomized into two groups of 40 each (Group A and Group F).IN Group F intubation was done using fibreoptic bronchoscope and Group A intubation was done using Airtraq videolaryngoscope. After data collection statistical analysis was done using independent t test, chi square test and ANOVA. We concluded that use of fibreoptic guided intubation had the added advantage of lesser haemodynamic variation compared to Airtraq videolaryngoscope. 
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