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CTRI Number  CTRI/2024/11/077174 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 07/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Scanning the neck to measure the size of the airway tube in children undergoing general anaesthesia for surgery 
Scientific Title of Study   An Observational study of endotracheal tube size estimation with ultrasound guided subglottic diameter measurement in paediatric patients undergoing surgery under general anaesthesia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R Pavithra 
Designation  Junior Resident in Anaesthesiology 
Affiliation  Sree Balaji Medical College and Hospital 
Address  Department of Anaesthesiology Sree Balaji Medical College and Hospital CLC works road Chrompet Chennai

Chennai
TAMIL NADU
600044
India 
Phone  9003867560  
Fax    
Email  pavithravi76@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yogaraj 
Designation  Professor of Anaesthesiology 
Affiliation  Sree Balaji Medical College and Hospital 
Address  Department of Anaesthesiology Sree Balaji Medical College and Hospital CLC Works road Chrompet Chennai

Chennai
TAMIL NADU
600044
India 
Phone  9884678869  
Fax    
Email  yogaraj1986@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Yogaraj 
Designation  Professor of Anaesthesiology 
Affiliation  Sree Balaji Medical College and Hospital 
Address  Department of Anaesthesiology Sree Balaji Medical College and Hospital CLC Works road Chrompet Chennai

Chennai
TAMIL NADU
600044
India 
Phone  9884678869  
Fax    
Email  yogaraj1986@yahoo.co.in  
 
Source of Monetary or Material Support  
Sree Balaji Medical College, No 7, CLC Works road, Chrompet, Chennai-600044 
 
Primary Sponsor  
Name  Sree Balaji Medical College and Hospital 
Address  Department of Anaesthesiology Sree Balaji Medical College and Hospital Department of Anaesthesiology No 7 CLC Works road Chrompet Chennai 44  
Type of Sponsor  Private 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 Pavithra  Sree Balaji Medical College   Sree Balaji Medical College and Hospital Department of Anaesthesiology No 7 CLC Works road Chrompet Chennai 44
Chennai
TAMIL NADU 
9003867560

pavithravi76@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SREE BALAJI MEDICAL COLLEGE AND HOSPITAL INSTITUTIONAL HUMAN ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R688||Other general symptoms and signs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  ASA I and II
Patient undergoing elective surgery with ET intubation under GA 
 
ExclusionCriteria 
Details  ASA III and IV 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Successful first pass intubation using endotracheal tube size (OD) matched with USG measurement of subglottic diameter  successful or failed first pass intubation 
 
Secondary Outcome  
Outcome  TimePoints 
Time to decide the ET tube size from the time of scanning to matching the ODs  in seconds 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   02/12/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

After doing routine pre-anaesthetic evaluation ,Paediatric patients undergoing surgery under general anaesthesia with ET Tube intubation will be enrolled. Patient will be kept NPO for solids 8hrs, liquids 2hrs prior to surgery. General anaesthesia will be initiated by the attending anaesthesiologist. After loss of  consciousness, bag and mask ventilation will be confirmed and weight based dose of long acting muscle relaxant will be given. The patient will be ventilated for 4minutes while performing the sonography.GE LOGIQ P7 machine with high resolution linear probe (4.5-13 MHz) in B mode will be used for scanning.  With head in extension and neck flexed (sniffing position) initial scanning will be done in sagittal section in the midline immediately above supra-sternal notch upwards. This is to identify the tracheal rings, and cricoid cartilage. At the level of cricoid cartilage, the probe will be rotated transversely with marker pointing towards right side. The  vocal cords are identified in transverse section  by moving the probe upwards. The probe is then moved again downwards to identify the sub glottis immediately below the vocal cords.  Transverse air column diameter will be measured at the cephalic half of cricoid cartilage taken as subglottic diameter. This is the outer diameter of the ETT that can be used for the patient.

Cuffed ETT OD = Subglottic diameter – 1mm

Uncuffed ETT OD = Subglottic diameter

The ETT will be chosen by matching the measured OD with manufacturers OD. Time taken to decide the size of the ETT from the time of scanning till matching the OD will be noted. Successful first pass of the ETT will be observed. After intubation, cuff pressure will be inflated to 15-20 cmH2O and audible air leak with stethoscope will be noted. Leak occurring at <10cmH2O ETT will be exchanged with 0.5mm smaller size ETT, Leak occurring at >20cm H20 will be exchanged with 0.5mm larger size ETT.

 Similarly, circuit pressure equilibration will be checked. Closed circuit will be connected to the ETT and flow rate will be  set to 6L/min with a closed adjustable pressure limiting valve closed to 30cmH2O allowing the circuit to fill up and pressurize to a circuit pressure of 30cm H2O. Then the flow meter will be closed fully and fall in pressure will be noted for 10 seconds , when the pressure equilibrates to a new value at the end of 10 seconds .If it equilibrates to 10 to 20 cm H2O after 10secs ETT will be considered appropriate. ETT will be considered large if the circuit pressure equilibrates at >20 cm H20 and ETT size will be considered small if the circuit pressure equilibrates to <10 cm H20 after 10 secs and will be changed accordingly by 0.5mm smaller or larger respectively. Adequate ventilation will be confirmed. The final size of the ETT will be compared with age based formula.

 

 
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