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CTRI Number  CTRI/2018/05/013870 [Registered on: 14/05/2018] Trial Registered Retrospectively
Last Modified On: 06/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Methods of securing a definitive airway in Cervical spine injured patients 
Scientific Title of Study   Comparative evaluation of tracheal intubation using airtraq and intubating laryngeal mask airway with cervical spine immobilisation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sivaraj 
Designation  Resident 
Affiliation  Maulana Azad Medical College and Lok Nayak Hospital 
Address  Maulana Azad Medical College Department of Anaesthesiology and Intensive Care Bahadur Shah Zafar Marg New Delhi
Bahadur shah zafar marg new delhi 110002
Central
DELHI
110002
India 
Phone  9717864257  
Fax    
Email  sushilkumardtu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonia Wadhawan 
Designation  resident 
Affiliation  Maulana Azad Medical College and Associated Lok Nayak Hospital 
Address  Maulana Azad Medical College and Associated Lok Nayak Hospital Department of Anaesthesiology Blt block 3rd floor Bahadur Shah Zafar Marg New Delhi
Bahadur shah zafar marg new delhi 110002
Central
DELHI
110002
India 
Phone  9810946845  
Fax    
Email  soniawadhawan@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sivaraj 
Designation  Resident 
Affiliation  Maulana Azad Medical College and Lok Nayak Hospital 
Address  Maulana Azad Medical College and Associated Lok Nayak Hospital Department of Anaesthesiology Bahadur Shah Zafar Marg New Delhi
Bahadur shah zafar marg new delhi 110002
Central
DELHI
110001
India 
Phone  9717864257  
Fax    
Email  sushilkumardtu@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College and Associated Lok Nayak Hospital Department of Anaesthesiology Bahadur Shah Zafar Marg New Delhi  
 
Primary Sponsor  
Name  Maulana Azad Medical College and Associated Lok Nayak Hospital 
Address  Maulana Azad Medical College and Associated Lok Nayak Hospital Department of Anaesthesiology Bahadur Shah Zafar Marg New Delhi  
Type of Sponsor  Research institution and hospital 
 
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 DEEPAK KUMAR  Maulana Azad Medical College and Associated Lok Nayak Hospital  Department of Anaesthesiology Surgery, Ortho, ENT , Gynaecology operation theatre
Central
DELHI 
9717864257

deepakkumar3090@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
maulana azad medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients admitted for elective surgeries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Airtraq  Airtraq is an optical laryngoscope designed to facilitate intubation 
Comparator Agent  Intubating Laryngeal Mask Airway  It is an advanced type of LMA airway device is an anatomically curved, short, wide tube attached to mask and guiding handle, designed to facilitate tracheal intubation with an endotracheal tube 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA I and II
2. Age between 18 and 60 years
3. Undergoing elective surgery
4. Modified Mallampati grade I and II
5. BMI<30
 
 
ExclusionCriteria 
Details  1. Patients with cervical spine or oral pathology
2. Airway distortion(post burn contracture)
3. Mouth opening less than 3cm
4. Pregnant Patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Time taken for intubation was defined as time taken from holding airway device for insertion to the first square shaped capnograph   Time taken for intubation was defined as time taken from holding airway device for insertion to the first square shaped capnograph  
 
Secondary Outcome  
Outcome  TimePoints 
Number of attempts taken
Ease of intubation with the device (Airtraq/ILMA) as graded by Likert scale.
Hemodynamic variables(HR,MAP)
Complications if any (trauma to oropharyngeal structures, blood stains on device/ETT) 
1) . In the ILMA group it was seen that the airway device was inserted in first attempt in 88% of patients while in rest of the patients (12%), a second attempt was needed. In the Airtraq group, airway of all patients (100%) was successfully secured in the first attempt
2) Likert scale of 3 was for the ILMA group while 4 was given for Airtraq group by the operator
3) Blood stain on removal of the ILMA device was seen in 2 patients as compared to none seen in the Airtraq group.  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   05/01/2017 
Date of Study Completion (India) 15/02/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="1"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   In our study we endeavoured to compare Airtraq with ILMA for tracheal intubation in simulated cervical spine injury patients with cervical spine immobilisation using MILS. Following Institutional Review Board approval and written informed consent, 100 adult patients between 18 to 60 years of age scheduled for elective surgery under general anesthesia were randomly allocated to one of the two groups (Airtraq group or ILMA group), 50 in each group. Patients with cervical spine or any oral pathology, airway distortion, mouth opening less than 3cm, pregnant patients were excluded from tthe study.

Standard anaesthesia technique was followed for all the patients. Inj. fentanyl 2 µg/kg IV was given. After 2mins, anaesthesia was induced  with Inj.propofol 2 mg/kg IV. Adequacy of ventilation was assessed and muscle relaxation was achieved with Inj. vecuronium bromide 0.1mg/Kg IV. Patient was ventilated with 100% O2 and isoflurane≤1%  for 3 mins. Subsequently the pre-checked and prepared airway device (Airtraq or ILMA) of appropriate size was inserted according to the standard technique after applying MILS. Hemodynamic parameters (HR, NIBP) was recorded just before device insertion  and then every minute till 10 mins after intubation.

The Primary outcome variable was time taken for intubation and it was taken from holding the airway device for insertion to the first square shaped capnograph (T1+T2). The number of attempts for insertion of airway device were noted. Pulse rate and mean arterial pressure were recorded after insertion of airway device in both the groups every minute for the first ten minutes. Complication like trauma to lip/tongue/oral mucosa and presence of blood on device after removal were noted. Statistical analysis of the data was done using the SSPS software version 22.0. P<0.05 was considered statistically significant.

There were no statistically significant differences in demographic characteristics between the groups. The mean time taken for the insertion of the airway device in the ILMA group was 1.43 ± 0.61 mins and in the Airtraq group was 0.21 ± 0.11 mins. The difference is statistically significant. Even though the time taken for intubation in the ILMA group is significantly longer than the Airtraq group, the uninterrupted ventilation maintained during intubation in the ILMA group ensured adequate oxygenation. In the ILMA group it was seen that airway device was inserted in first attempt in 88% patients and a second attempt was needed in the remaining 12%. In the Airtraq group, airway of all patients (100%) was successfully secured in first attempt and this difference was found to be statistically significant (p=0.027). The intubator found intubation using Airtraq easier than intubating with ILMA as graded by the Likert scale ( 4 vs 3 in Airtraq group vs ILMA group). In the hemodynamic parameters, we found that baseline values for both heart rate and MAP in both the groups were similar without any significant difference. However, when the heart rate was compared at different time frames from the insertion of the airway devices i.e. at 2, 3, 4, 5, 6, 7, 8, 9, and 10 minutes of insertion it was found that the mean difference between both the groups was statistically significant. It was observed that the heart rate in Airtraq group is more controlled and stable as compared to the ILMA group. We observed that there was immediate rise in MAP (at 1, 2 and 3 mins) in both the groups after insertion of the airway device which was more in the ILMA group as compared to the Airtraq group, though this difference was not statistically significant. This could have been due to the sympathetic stimulation seen during airway manipulation.Subsequently, when the MAP was compared at time frames of 4, 5, 6, 7, 8, 9  minutes after insertion of the airway device in both the groups, the difference was statistically significant and  the readings were found to be more controlled in the Airtraq group as compared to the ILMA group. Blood stain on the ILMA device after removal was seen in 2 patients as compared to none seen in the Airtraq group. The difference was statistically not significant.

From our study, we suggest the use of Airtraq in difficult airway scenarios with limited/ restricted neck movements. Decreased hemodynamic response to intubation using Airtraq makes it a promising device in patients with CAD and hypertension.
 
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