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CTRI Number  CTRI/2019/11/022061 [Registered on: 19/11/2019] Trial Registered Prospectively
Last Modified On: 14/09/2022
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 two videolaryngoscopes for intubation 
Scientific Title of Study   Airtraq and Kingvision videolaryngoscopes for tracheal intubation - A prospective randomised study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sujata Chaudhary 
Designation  Director Professor 
Affiliation  University College of Medical Sciences 
Address  Room No. 400 PCNL OT 4th Floor GTB Hospital Dilshad Garden

North East
DELHI
110095
India 
Phone  9625900800  
Fax    
Email  sujatac462@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sujata Chaudhary 
Designation  Director Professor 
Affiliation  University College of Medical Sciences 
Address  Room No. 400 PCNL OT 4th Floor GTB Hospital Dilshad Garden

North East
DELHI
110095
India 
Phone  9625900800  
Fax    
Email  sujatac462@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pushpa Patel 
Designation  PG student 
Affiliation  University College of Medical Sciences 
Address  Room No. 400 PCNL OT 4th Floor GTB Hospital Dilshad Garden

North East
DELHI
110095
India 
Phone  6232079952  
Fax    
Email  pushpapatel36910@gmail.com  
 
Source of Monetary or Material Support  
University College of Medical Sciences Dilshad Garden Delhi 
 
Primary Sponsor  
Name  University College of Medical Sciences 
Address  Room No 400 Department of Anaesthesiology UCMS and GTB Hospital Dilshad Garden Delhi 
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 Sujata Chaudhary  UCMS and GTB Hospital  Room No. 400 Department of Anaesthesiology Dilshad Garden Delhi
North East
DELHI 		 9625900800

sujatac462@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H712||Cholesteatoma of mastoid, (2) ICD-10 Condition: H652||Chronic serous otitis media, (3) ICD-10 Condition: K36||Other appendicitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Airtraq videolaryngoscope  This device will be used for tracheal intubation. 
Comparator Agent  Kingvision videolaryngoscope  This device will be used for tracheal intubation. 
Intervention  One of the two airway devices will be used to perform tracheal intubation.   Performance characteristics of the two videolaryngoscopes for tracheal intubation will be observed. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Weight – 40-70 kg
ASA Grade I and II
Mallampatti grade I and II
Patient scheduled for elective surgeries requiring endotracheal intubation
 
 
ExclusionCriteria 
Details  Patients with risk of aspiration
Difficult intubation
Patients with mouth opening less than 18 mm in males and 16 mm in females
Patients not giving consent to participate in the study
Patients with cardiovascular diseases
Patients with oral pathology
Patients with neck flexion deformity
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to successful endotracheal intubation  Once after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
Intubation characteristics
Laryngoscopic view
 		 Once after intubation 
Haemodynamic parameters  Baseline: just before induction.
T1: after induction with Propofol.
T2: pre intubation.
T3: after intubation.
T4: 1 min after intubation
T5: 3 min after intubation
T6: 5 min after intubation
T7: 10 min after intubation
T8: 15 min after intubation
 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/11/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Rationale:Laryngoscopy and intubation are very crucial for securing airway in patients. Videolaryngoscopy has made intubation much safer and easier than conventional laryngoscopy. Thechannelled videolaryngoscopeshave the potential to reduce the duration of laryngoscopy and intubation and thus the consequent hemodynamic responses. AirtraqTMand King VisionTMchannelled videolaryngoscopes have been compared in a limited number of studies and these studies have contradictory results.

Aim–To compare Airtraq and King Vision Videolaryngoscopes for tracheal intubation.

Objectives: - To compare Airtraq and King Vision channelled Videolaryngoscopes in terms of-

PRIMARY OBJECTIVE- Time to successful endotracheal intubation

SECONDARY OBJECTIVES-

1.    Intubating conditions-

·         Time to view the vocal cords

·         Time to advance the tube

·         Intubation difficulty score

·         Number and type of manoeuvres used during intubation

·         First attempt success rate

·         Number of attempts 

·         Overall success rate

·         Incidence of failed intubation

2.    Laryngoscopic  view-

·         Cormack- Lehane grading

·         Percentage of glottic opening(POGO) score

3.    Hemodynamic responses-

·         Changes in Systolic, Diastolic and Mean Arterial blood pressure

·         Changes in heart rate

·         Changes in SpO2

4.    Complications if any-Blood staining of the device / Hoarseness/Sore throat/any other

Place of study Department of Anaesthesiology, Critical Care & Pain MedicineUniversity College of Medical Sciences (University of Delhi) and Guru Teg Bahadur Hospital, Delhi

Study period: November 2019 to April 2021.

Study design: After obtaining approval from the Institutional Ethics Committee, this prospective, randomized analytical study will be undertaken after taking written informed consent from all the participants.

Sample size: – 25 patients for each group is required. Therefore, a total number of 50 patients will be included in the study.

 

PATIENT SELECTION:

Inclusion criteria

1.    Age- 20-60 years

2.    Weight – 40-70 kg

3.    ASA Grade I and II

4.    Mallampatti grade I and II

5.    Patient scheduled for elective surgery requiring endotracheal intubation

 

Exclusion criteria

1.    Patients with risk of aspiration

2.    Difficult intubation

3.    Patients with mouth opening less than 18mm in males and 16mm in females

4.    Patients not giving consent to participate in the study

5.    Patients with cardiovascular diseases

6.    Patients with oral pathology

7.    Patients with neck flexion deformity

 

Randomization and group allocation: -Using a computer generated random number table, the patients will be randomly allocated to one of the two groups-

Group A - patients undergoing intubation by Airtraq

Group K - patients undergoing intubation by King Vision.

 

MATERIALS AND METHODS

Patient fulfilling the above mentioned inclusion criteria and willing to become a part of the study will be selected.A pre-anaesthetic evaluation will be done one day prior to surgery. A written informed consent will be taken. Tablet Alprazolam 0.25mg and Ranitidine 150mg shall be administered on the night before and morning of surgery. In the operating room, monitors will be attached and patient’s vitals will be recorded. (ECG, NIBP, heart rate).Intravenous line will be secured.Standard general anaesthesia technique will be started. After confirmation of adequate bag and mask ventilation, neuromuscular relaxation will be instituted using Inj. Vecuronium 0.1mg/kg i.v. Videolaryngoscopy will be performed after at least 3 min of muscle relaxation with the laryngoscope as per group allocation. After obtaining glottic view C-L grading and POGO scoring will be done.In cases with any difficulty in obtaining the glottic view manoeuvres will be applied.Intubation will then be performed with an appropriately sized endotracheal tube.

The following parameters will be noted-

1.Time to view the vocal cords

2. Time to advance the tube

3.  Intubation Difficulty Score

4.  Any manoeuvre used

5.  Heart rate

6.  Systolic blood pressure

7.  Diastolic blood pressure

 8.  Mean arterial blood pressure

Parameters will be recorded at following intervals-.Baseline, T1, T2, T3, T4, T5, T6, T7, T8. Thereafter the readings will be taken 1, 3, 5, 10, 15 minutes after intubation.

 

Outcome measures

1.    Time to successful endotracheal intubation

2.    Time to view the vocal cords

3.    Time to advance the tube

4.    Intubation Difficulty Score

5.    First attempt success rate

6.    Number of attempts of laryngoscopy and intubation

7.    Any manoeuvres required

8.    Overall success rate

9.    Incidence of failed intubation

10. Laryngoscopic view: POGO Score,Cormack & Lehane Grading

11. Hemodynamic responses

12. Complications

 

Statistical analysis

 All statistical analysis will be carried out in SPSS version 20.0. One time measured quantitative measures will be compared by Unpaired t-test/ Mann Whitney U test depending on the nature of data. Repeatedly measured quantitative measures will be compared by repeated measure ANOVA followed by Dunnett’s test. Qualitative parameter will be compared by Chi Square/ Fischer exact test. P value <0.05 will be considered significant.

 
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