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CTRI Number  CTRI/2016/10/007390 [Registered on: 20/10/2016] Trial Registered Retrospectively
Last Modified On: 18/10/2016
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Ease of airtraq use for insertion of tube in windpipe of children 
Scientific Title of Study   An observational study of feasibility of tracheal intubation using airtraq in paediatric population 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
LTMMC/IEC/59/15 dated 30.09.2015  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Devendra Thakare 
Designation  Assistant Professor 
Affiliation  LTMMC and LTMGH  
Address  503 new RMO doctors quarters sion hospital campus SION west

Mumbai
MAHARASHTRA
400022
India 
Phone  09892954998  
Fax    
Email  devendra.thakare@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anila Malde 
Designation  Professor 
Affiliation  LTMMC and LTMGH  
Address  Department of Anaesthesia,LTMMC and LTMGH, Dr. Babasaheb Ambedkar Road, Sion West, Mumbai, Maharashtra 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9821085730  
Fax    
Email  dradmalde@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Devendra Thakare 
Designation  Assistant Professor 
Affiliation  LTMMC and LTMGH  
Address  503,new RMO doctors quarters,sion hospital campus,SION west

Mumbai
MAHARASHTRA
400022
India 
Phone  9892954998  
Fax    
Email  devendra.thakare@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal Medical College & General Hospital, Dr. Babasaheb Ambedkar Road, Sion West, Mumbai, Maharashtra - 400022  
 
Primary Sponsor  
Name  LTMMC and LTMGH 
Address  Department of Anaesthesia,LTMMC and LTMGH, Dr. Babasaheb Ambedkar Road, Sion West, Mumbai, Maharashtra 400022 
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 DEVENDRA THAKARE  Lokmanya Tilak Municipal Medical College & General Hospital  Dr. Babasaheb Ambedkar Road, Sion West, Mumbai, Maharashtra 400022
Mumbai
MAHARASHTRA 
02224049023

doasionhospital@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
LTMMC AND LTMGH STAFF AND RESEARCH SOCIETY (ESTD.1967) Bombay Public Trust Act. Reg. No. F/1669 of 21-9-1968, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Age - 3 months to 18 years Either sex ASA I and II Patients undergoing general anaesthesia with endotracheal intubation using airtraq ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  3.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. American Sosciety of Anaesthesiologists I and II
2. Patients undergoing general anaesthesia with endotracheal intubation using airtraq
 
 
ExclusionCriteria 
Details  1. Difficult airway or history of difficult intubation
2. Risk of gastric aspiration
3. Active upper or lower respiratory tract infection
4. Severely raised intracranial tension
5. Cyanotic heart disease
6. Non consenting parent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time to intubation (TTI) in seconds  Time to intubation : Time interval between blade entry past the lips and the appearance of first upstroke of the end-tidal CO2 tracing

 
 
Secondary Outcome  
Outcome  TimePoints 
1. Percentage of glottis opening (POGO) score %

2. Visual analogue scores (VAS) for field of view

3. Time to best view (TTBV)

4. Visual Analogue Scale(VAS) for ease of use 
1. Percentage of glottis opening (POGO) score % : 0 to 100

2. Visual analogue scores (VAS) for field of view : 0 to 10 -point scale.

3. Time to best view (TTBV) in seconds : Time interval between blade entry past the lips and the laryngoscopist’s verbal declaration that the best view for endotracheal intubation is achieved.

4. Visual Analogue Scale(VAS) for ease of use : 0 to 10 -point scale.  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/10/2015 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Reference. White MC, Marsh CJ, Beringer RM, Nolan JA, Choi AYS, Medlock KE, Mason DG. A randomised control trial comparing the AirtraqTM optical laryngoscope with conventional laryngoscopy in infants and children. Anaesthesia 2012; 67: 226–231 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

After approval from the ethics committee, patients in the age group of 3 months to 18 years scheduled for routine surgical procedure under general anaesthesia with endotracheal intubation using airtraq (AT) will be observed during the period of the study. Any co-existing medical disease, associated congenital anomalies and airway problems and will be noted. Written valid informed consent will be taken from the respective parent or guardian. If the child can understand the nature of procedure, he or she will be explained about the study and assent will be taken.

All children will receive general anaesthesia as per routine protocol followed in various operation theatres in LTMGH, Sion. This usually comprises of:

  • Preoperative starvation as per ASA fasting guidelines 2011
  • Establishment of monitoring like electrocardiogram, pulse oximetry, capnography and non invasive blood pressure measurement
  • Premedication in form of antisialogogue, sedatives and analgesic
  • Either Intravenous or Inhalational induction
  • Checking of adequate depth of anaesthesia
  • Confirmation of adequacy of ventilation without gastric insufflation
  • Administration of neuromuscular blockade
  • Intubation using AT laryngoscope by experienced anaesthesiologists as per manufacturer’s instructions (appendix B)
  • Sizes of AT laryngoscope used ( appendix C)
  • Confirmation of proper endotracheal intubation by observation of chest expansion, auscultation of bilateral breath sounds and square wave capnogram

 Following parameters will be assessed

 1. Percentage of glottis opening (POGO) score:  denotes visual estimation of laryngeal opening in score of 0% to 100%. (appendix A)

A POGO score of 100 = full visualisation of larynx from the interarytenoid notch to anterior commissure of the vocal cords; 0 = none of the glottis opening is seen.

 2Visual analogue scores (VAS) for field of view :  0 to 10 -point scale. 0 = poor, 10 = excellent

 3. Time to best view (TTBV):  time interval between blade entry past the lips and the laryngoscopist’s verbal declaration that the best view for endotracheal intubation is achieved.

 4. Time to intubation (TTI): time interval between blade entry past the lips and the  appearance of first upstroke of the end-tidal CO2 tracing.

 5. Visual Analogue Scale(VAS) for ease of use0 to 10 -point scale. 0 = poor, 10 = excellent

 

Failed attempts, if any will be noted.

Failed attempt is considered when:

  1. Inability to pass endotracheal tube within 60 seconds of AT blade entry past the lips
  2. Abandoning the intubation attempt due to decrease in oxygen saturation < 94%
  3. Change of premounted endotracheal tube

In our set up more than two intubation attempts with any device are not allowed.

 

Failed intubation is considered when successful intubation with airtraq is not possible.

 

Difficulties encountered e.g. anterior or posterior impingement of ET tube; loss of visualization due to “fogging” or “red-out” will be noted.

 

Optimization manoeuvres required (if any) will be noted.

  Commonly used optimization manoeuvres are:

·         repositioning the head or the need for a second assistant to aid tracheal intubation

·         use of external laryngeal manipulation

 

Complications associated with laryngoscopy-intubation, if any will be noted

 

STATISTICAL ANALYSIS

Data which are normally distributed will be presented as means ± standard deviation (M ± SD) for continuous variables. Data which is not normally distributed will be presented as median with interquartile range (median with IQR).

A subgroup analysis will be done depending on the size of the AT used. Any difference between the parameters will be studied using ANOVA test. Any significant difference in the parameters in individual group will be compared using unpaired t test. Categorical data like failed attempts, difficulties encountered in each subgroup will be studied by using Chi square test or Fisher’s exact test.                     

 
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