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CTRI Number  CTRI/2017/08/009380 [Registered on: 16/08/2017] Trial Registered Prospectively
Last Modified On: 05/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparison of two medical devices for inserting tube in the windpipe in a difficult situation.  
Scientific Title of Study   A comparative evaluation of two Videolaryngoscopes as an intubation Aid in a simulated difficult airway: a prospective randomized study 
Trial Acronym  none 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajay Kumar 
Designation  Senior Specialist 
Affiliation  Deen Dayal Upadhyay Hospital, Govt. of NCT of Delhi 
Address  Department of anaesthesiology and Critical care, Deen Dayal Upadhyay Hospital, New Delhi

West
DELHI
110064
India 
Phone  9718990114  
Fax    
Email  ajayannu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ajay Kumar 
Designation  Senior Specialist 
Affiliation  Deen Dayal Upadhyay Hospital, Govt. of NCT of Delhi 
Address  Department of anaesthesiology and Critical care, Deen Dayal Upadhyay Hospital, New Delhi

West
DELHI
110064
India 
Phone  9718990114  
Fax    
Email  ajayannu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anupma Taluja 
Designation  Post Graduate Student 
Affiliation  Deen Dayal Upadhyay Hospital, Govt. of NCT of Delhi 
Address  Department of anaesthesiology and Critical care, Deen Dayal Upadhyay Hospital, New Delhi

West
DELHI
110064
India 
Phone  9460559857  
Fax    
Email  anupmataluja@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Deen Dayal Upadhyay Hospital 
Address  Department of anaesthesiology and Critical care, Deen Dayal Upadhyay Hospital, New Delhi- 110064 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
none   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajay Kumar  Deen Dayal Upadhyay Hospital, Govt of NCT of delhi  Seminar Room, near pain clinic, 2nd floor, Main OT block, Department of Anesthesiology and Critical Care, Deen Dayal Upadhyay Hospital, New Delhi-110064
West
DELHI 
9718990114

ajayannu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee, Deen Dayal Upadhyay Hospital, Hari Nagar, Delhi-110064, Govt of NCT of Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients aged 18 to 60 years, of either gender, ASA physical status I or II, undergoing elective surgery under general anaesthesia requiring orotracheal intubation ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Endotracheal intubation using King Vision video laryngoscope  In this group first laryngoscopy will be performed using McGrath Mac video laryngoscope; laryngoscopic view obtained will be graded and time taken to obtain optimal laryngoscopic view noted. The patient will be ventilated with 100% oxygen before laryngoscopy with the second device. The King Vision video laryngoscope will be used to perform second laryngoscopy. After noting the laryngoscopic view and time taken to obtain optimal laryngoscopic view, trachea will be intubated with this second device and time taken for tracheal intubation will be recorded. 
Intervention  Endotracheal intubation using McGrath Mac video laryngoscope  In this group first laryngoscopy will be performed using King Vision video laryngoscope; laryngoscopic view obtained will be graded and time taken to obtain optimal laryngoscopic view noted. The patient will be ventilated with 100% oxygen before laryngoscopy with the second device. The McGrath Mac video laryngoscope will be used to perform second laryngoscopy. After noting the laryngoscopic view and time taken to obtain optimal laryngoscopic view, trachea will be intubated with this second device and time taken for tracheal intubation will be recorded.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The study will be performed in adult patients, aged 18 to 60 years, of either gender, American Society of Anaesthesiologists (ASA) physical status grade I or II, undergoing elective surgery under general anaesthesia requiring oro-tracheal intubation. 
 
ExclusionCriteria 
Details  Patients with known or anticipated difficult airway (modified Mallampati class 3 or 4, thyromental distance < 6cm, inter-incisor distance < 3.5 cm and restricted neck mobility)
Patients with oral or laryngeal pathology, cervical spine injury or disease, obesity, cardiovascular or respiratory disease, loose or absent front dentition, risk factors for gastric aspiration such as pregnancy, diabetes, etc.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
First attempt intubation success  180 seconds from the time of insertion of laryngoscope blade between the incisors 
 
Secondary Outcome  
Outcome  TimePoints 
Laryngeal view obtained during laryngoscopy, time taken to obtain optimal laryngoscopic view, time taken for endotracheal intubation, number of intubation attempts, ease of intubation, haemodynamic parameters and complications if any.  180 seconds from the time of insertion of laryngoscope blade between the incisors 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/08/2017 
Date of Study Completion (India) 16/04/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Thesis submited 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

A preanaesthetic checkup will be done for all the patients at least one day prior to surgery. A detailed history will be obtained followed by general physical and systemic examination. Physical characteristics such as age, height, weight and body mass index will be noted. Investigations will be done as per hospital protocol. After explaining the entire procedure to the patient a written informed consent will be taken.

Patients will fast overnight and will receive tablet alprazolam 0.25 mg night before and two hours prior to surgery. They will be randomly assigned to one of the two study groups by computer-generated randomisation using sealed opaque envelopes.

Group K- KingVision® video laryngoscope with the channeled blade attachment will be used as an intubating aid in a simulated difficult airway.

Group M- McGrath® MAC video laryngoscope will be used as an intubating aid in a simulated difficult airway.

In the operation theatre, standard monitors (electrocardiograph, non-invasive blood pressure and pulse oximeter) will be applied and baseline readings noted. Using18 gauge cannula vascular access will be secured. Anaesthesia will be induced with intravenous fentanyl 2µg/kg and propofol 2 mg/kg. After confirming that bag-mask ventilation is adequate, vecuronium bromide 0.1 mg/kg will be given intravenously for neuromuscular blockade. Once adequate muscle relaxation is achieved, the inter-incisor distance at maximal mouth opening will be measured. To simulate a difficult airway, an appropriately sized cervical collar will be applied. The inter-incisor distance will be again measured and noted (aiming at 25mm).

The anaesthesiologist inserting the study device would have received prior training on manikin and have used both the study devices before at least 10 times clinically. In group M, First laryngoscopy will be performed with the KingVision® video laryngoscope, the laryngoscopic view will be graded and time taken to obtain an optimal laryngoscopic view (centralising the vocal cords in view) will be noted. The patient will be ventilated with 100% oxygen before introduction of the second device. The McGrath® MAC video laryngoscope will be used to perform a second laryngoscopy. After noting the grade and time taken to obtain optimal laryngoscopic view, the trachea will be intubated using this second device and the time taken for tracheal intubation will be noted.

In group K, First laryngoscopy will be performed with the McGrath® MAC video laryngoscope, the laryngoscopic view will be graded and time taken to obtain optimal laryngoscopic view noted. The patient will be ventilated with 100% oxygen before introduction of the second device. The KingVision® video laryngoscope will be used to perform second laryngoscopy. After noting the grade and time taken to obtain optimal laryngoscopic view, the trachea will be intubated using this second device and the time taken for tracheal intubation will be noted.

Thus, while both airway devices will be used to perform laryngoscopy, the trachea will be intubated only once. Tracheal intubation will be done with tracheal tube of size 7.0 for females and 8.0 for males. Correct placement of tracheal tube will be confirmed by capnography and chest auscultation for bilateral breath sounds. Anaesthesia will be maintained using vecuronium bromide, nitrous oxide (66%), and isoflurane in oxygen. At the end of surgery, residual neuromuscular blockade will be reversed using injection neostigmine and glycopyrolate.

If the first attempt at tracheal intubation fails, then the patient will be ventilated using bag and mask and 100% oxygen to avoid desaturation. The duration of subsequent attempt will be added to the time to tracheal intubation.

Manoeuvres to facilitate tracheal intubation may be used as desired by the intubator and these will be noted.

Only two attempts will be allowed for tracheal intubation with either of the two devices. In case of failed intubation, the cervical collar will be removed and alternative airway management plan would be instituted.

The study will be terminated after two unsuccessful attempts, or upon occurrence of airway injury, bronchospasm, technical failure, or a reduction of oxygen saturation below 90%.


Patients will be monitored continuously throughout the surgical procedure. Readings of heart rate, systolic, diastolic and mean blood pressure and peripheral oxygen saturation will be noted immediately before induction as baseline, immediately after anaesthesia is induced, at insertion of First study device, at insertion of second study device, at intubation, and at one, three and five minutes’ post intubation.

Grading of laryngoscopic view will be done using the modified Cormack and Lehane grade  and the percentage of glottic opening.

Ease of intubation with each device, will be graded by the intubator on a scale from 0 (extremely easy) to 10 (extremely difficult).

The study data will be collected and analysed statistically.

McGrath® MAC VL as compared to King Vision® VL resulted in shorter TLV and TTI but had comparable first attempt intubation success.


 
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