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CTRI Number  CTRI/2017/06/008940 [Registered on: 29/06/2017] Trial Registered Retrospectively
Last Modified On: 29/06/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Airtraq and Kingvision videolaryngoscope for intubation in adults. 
Scientific Title of Study   A comparative evaluation of two videolaryngoscopes (The Airtraq and Kingvision) as an intubating aid in adult patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Devyani Desai 
Designation  Associate Professor 
Affiliation  Govt Medical college Vadodara 
Address  22-Soham Bunglows-1 Behind Palm view apt Vasna Road Vadodara
Dept of Anaesthesiology S S G Hospital Govt Medical college Vadodara
Vadodara
GUJARAT
390007
India 
Phone  9909983168  
Fax    
Email  devyani.dr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Devyani Desai 
Designation  Associate Professor 
Affiliation  Govt Medical college Vadodara 
Address  22-Soham Bunglows-1 Behind Palm view apt Vasna Road Vadodara
Dept of Anaesthesiology S S G Hospital Govt Medical college Vadodara
Vadodara
GUJARAT
390007
India 
Phone  9909983168  
Fax    
Email  devyani.dr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shweta  
Designation  2nd year resident 
Affiliation  Govt Medical college Vadodara 
Address  Room No6 New PG2 medical hostel Opposite Kuberbhavan Near Kothi char rasta Vadodara
Govt Medical College S S G Hospital Vadodara
Vadodara
GUJARAT
390001
India 
Phone  9408723517  
Fax    
Email  drshweta2309@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  S S G Hospital 
Address  Jail road, Vadodara, Gujarat 
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 Devyani Desai  Govt Medical College, Vadodara, Gujarat  Department of general surgery, ENT, Gynaecology and Plastic surgery C1,C2,C3.C4,D1,D2,D3,D4,ENT RR,E1,10 S S G Hosp, Vadodara, Gujarat  
Vadodara
GUJARAT 
9909983168

devyani.dr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research, Medical College, Vadodara  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Age:18-60 yrs. Weight: 40-70kg of either sex. Mallampatti grade I & II Mouth opening 20mm ASA I & II Posted for elective surgeries under general anaesthesia and intubation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Airtraq videolaryngoscope  After inducing the patient with Inj Propofol and proper relaxation with Inj Succinyl Choline, endotracheal intubation was done using Airtraq videolayngoscope  
Intervention  Kingvision videolaryngoscope  After inducing the patient with Inj Propofol and proper relaxation with Inj Succinyl Choline, endotracheal intubation was done using Kingvision videolayngoscope  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient willing to participate in study group.
Patients posted for elective surgery requiring general anesthesia and Endotracheal Intubation for planned surgery.
Age:18-60 yrs.
Weight: 40-70kg of either sex.
Mallampatti grade I & II
Mouth opening >20mm
ASA I & II
 
 
ExclusionCriteria 
Details  Cervical spine disorder
Thyromental distance less than 6cm
Stern mental distance less than 12 cm
Neck circumference more than 42cm
Obesity (BMI ≥ 30)
Pregnant patients
Known case of GERD
Oropharyngeal pathology
Emergency surgeries

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare Airtraq and King vision in terms of following parameters-
1. Time of video laryngoscopy: Time taken from introduction of Video laryngoscope to view of glottis. (T1)
2. Time of tube insertion: Time taken from view of glottis to insertion of endotracheal tube and confirmation by CAPNOGRAPHY. (T2)

3. Total duration of intubation (T1+T2)
4. No. of attempts of Video laryngoscope insertion
5. Quality of visualization of Glottic aperture
 
Time of videolaryngoscopy. tube insertion and intubation in Seconds
Vitals at 0,5,10 and 15 min 
 
Secondary Outcome  
Outcome  TimePoints 
1. Optimization maneuvers required for intubation
2. Vital parameters
3. Incidence of airway trauma and complications.
 
Score - 0,1,2,3
Baseline, 5, 10, 15 and postopratively 
 
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)   01/06/2017 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Yet to be done and then published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
This randomized controlled trial will be carried out in SSG hosp during a period of one year after march 2017. We will be enrolling 30 patients in each group after getting the sample size estimation using n master statistical software considering alpha error 0.05, confidence interval 95% and power 80%. After through preanaesthetic check up and informed written consent, patient will taken inside the operation theatre and multipara monitor will be attached. Preoperative vitals will be checked. In case of Airtraq videolaryngoscope, the CMOS camera will be mounted on it and checked by watching the image on the monitor.In case of Kingvision videolaryngoscope,blade will be mounted and checked by pushing the on button and checking the image on the monitor. For both the devices, the tube to be used will be lubricated with Lignocaine jelly and the respective device will be preloaded with 7.5 in case of females and 8.5 in case of males. All patients will be premedicated with Inj Glycopyrolate 0.2mg intramuscularly 30 mins before and Inj Fentanyl  2mcg/kg intravenously 5mins before induction. After inducing the patient with Inj Propofol 2mg/kg and getting proper muscle relaxation with Inj Succinyl Choline 2mg/kg, patient will be intubated using either of the device in neutral head position. The study population will be randomly allocated to two groups : Group A in whon Airtraq and Group K in whom will be used. Videolaryngoscopy time, Tube insertion time, Total duration of intubation, Number of attempts, Optimization manoeuvers required, Quality of glottis aperture, Vital parameters and Incidences of airway trauma will be recorded. Data will be tabulated and presented in mean and SD form and p value <0.05 will be considered significant.
 
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