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CTRI Number  CTRI/2024/02/062295 [Registered on: 05/02/2024] Trial Registered Prospectively
Last Modified On: 26/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To measure breathing tube size with Ultrasound and compare to age related formula in children who undergo surgeries under general anesthesia. 
Scientific Title of Study   The accuracy of ultrasound to predict endotracheal tube diameter in pediatric population undergoing general anaesthesia when compared to traditional age based formulae. A Prospective Randomized Comparative study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anish Waghray 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences , Bibinagar. 
Address  Dept. Of Anaesthesiology , All India Institute of Medical Sciences Bibinagar . Hyderabad . Telangana India

Hyderabad
TELANGANA
508126
India 
Phone  9966883424  
Fax    
Email  anishwaghray@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ayya Syama Sundar 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences , Bibinagar. 
Address  Dept. Of Anaesthesiology , All India Institute of Medical Sciences Bibinagar . Hyderabad . Telangana India

Hyderabad
TELANGANA
508126
India 
Phone  8179309677  
Fax    
Email  sasyasyama@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ayya Syama Sundar 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences , Bibinagar. 
Address  Dept. Of Anaesthesiology , All India Institute of Medical Sciences Bibinagar . Hyderabad . Telangana India


TELANGANA
508126
India 
Phone  8179309677  
Fax    
Email  sasyasyama@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences , Bibinagar. 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences , Bibinagar. 
Address  All India Institute of Medical Sciences , Bibinagar. Hyderabad 508126 . Telangana 
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 Anish Waghray  All India Institute of Medical Sciences , Bibinagar.  Department of Anaesthesiology , Room no 49 , A Block ,Ground Floor .All India Institute of Medical Sciences , Bibinagar. 508126
Hyderabad
TELANGANA 
9966883424

anishwaghray@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS IEC BBN  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q381||Ankyloglossia, (2) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (3) ICD-10 Condition: Z412||Encounter for routine and ritual male circumcision, (4) ICD-10 Condition: N602||Fibroadenosis of breast, (5) ICD-10 Condition: N433||Hydrocele, unspecified, (6) ICD-10 Condition: Q181||Preauricular sinus and cyst, (7) ICD-10 Condition: Q531||Undescended testicle, unilateral, (8) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  age related formula   age related formula for endo tracheal tube size is used in one group of pediatric patients undergoing general anaesthesia.These calculations will be done at baseline. 
Intervention  ultrasound to predict endotracheal diameter  using ultrasound to measure sub glottic diameter to predict endo tracheal tube size in pediatric patients undergoing general anesthesia. These calculations will be done at baseline .  
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Age between 6 months to 12 years.
2.Elective surgery requiring General Anaesthesia
3.ASA 1 and 2
 
 
ExclusionCriteria 
Details  1.Patients with development anomalies of face/skull
2.Patients with surgeries for tracheal / laryngeal pathology
3.Emergency surgery
4.Recent Upper Respiratory Tract Infection
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Intubation by
1 Age related formula
2 usg measurement

 
Baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
1 number of endotraceal tubes used / wasted  post laryngoscopy 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/02/2024 
Date of Study Completion (India) 29/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="20" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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  

A formula to predict the correct size of the endotracheal tube (ETT) to be used in the paediatric patient was first proposed by Cole in 1957 and this is the most commonly used formula even today. Due to the wide variations in the size of children and the frequent inaccuracy of the calculated ETT size, other complex formulae using multiple variables such as age, height and weight were proposed, but did not gain wide use in clinical practice. Intubation of paediatric patients with an ETT that is too small may result in insufficient ventilation, poor reliability of end-tidal gas monitoring, leakage of anaesthetic gases into the operating room environment, and an enhanced risk of aspiration. In contrast, an ETT that is too large can cause upper airway damage (e.g., laryngeal oedema, stridor, local ischaemia, ulceration, granulation, scar formation) and potential for subsequent subglottic stenosis. Repeated laryngoscopies and reintubations may be needed to identify the appropriately sized tube. Some recent reports suggest that the diameter of the subglottic upper airway can be determined by ultrasound in young adults and paediatric patients. ETT size in paediatric population is traditionally determined by age related formulae. Altogether 22 formulae to estimate appropriate endotracheal tube size for paediatric patients (age 0-12 years) were identified: 12 age-based formulas for tubes without a cuff, 4 height-based formulas for tubes without a cuff, 2 weight-based formulas for tubes without a cuff and one multivariate formula for tubes without a cuff as well as 3 age-based formulas for cuffed endotracheal tubes.

Ultrasound has been used in adults to verify accurate placement of ETT but minimally used in paediatric population. Ultrasound can reliably measure the sub glottic diameter which corresponds to maximum outer diameter of ET tube that can be secured. This will also help in reducing wastage of ET tubes, eventually helping with reducing the economic burden and being environmentally friendly.

 
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