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CTRI Number  CTRI/2025/07/090260 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 04/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two methods for estimating endotracheal tube insertion depth in newborn. 
Scientific Title of Study   Nasal septum tragal length versus weight based formula to predict optimal endotracheal tube insertion depth in neonates: an open-label randomised controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gaurav Bindukumar Pandey 
Designation  Junior resident 
Affiliation  Government medical college and hospital chhatrapati sambhaji nagar 
Address  Pediatric ward 24,surgical building,second floor,ghati hospital,government medical college and hospital chhatrapati sambhaji nagar university road jubilee park Aurangabad 431004

Aurangabad
MAHARASHTRA
431004
India 
Phone  7977438293  
Fax    
Email  gauravpandey2506@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Trupti Gujarati Joshi 
Designation  Associate Professor 
Affiliation  Government medical college and hospital chhatrapati sambhaji nagar 
Address  Pediatric ward 24,surgical building,second floor,ghati hospital,government medical college and hospital chhatrapati sambhaji nagar university road jubilee park Aurangabad 431004

Aurangabad
MAHARASHTRA
431004
India 
Phone  9823900642  
Fax    
Email  drtruptijoshi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Gaurav Bindukumar Pandey 
Designation  Junior resident 
Affiliation  Government medical college and hospital chhatrapati sambhaji nagar 
Address  Pediatric ward 24,surgical building,second floor,ghati hospital,government medical college and hospital chhatrapati sambhaji nagar university road jubilee park Aurangabad 431004

Aurangabad
MAHARASHTRA
431004
India 
Phone  7977438293  
Fax    
Email  gauravpandey2506@gmail.com  
 
Source of Monetary or Material Support  
Government medical college and hospital chhatrapati sambhaji nagar aurangabad 
 
Primary Sponsor  
Name  Gaurav Bindukumar Pandey 
Address  Pediatric ward 24,second floor ,surgical building,ghati hospital,Government medical college and hospital chhatrapati sambhaji nagar ,university road,jubilee park,Aurangabad 431004 
Type of Sponsor  Other [SELF] 
 
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 Gaurav Bindukumar Pandey  Government medical college and hospital chhatrapati sambhaji nagar   HOD office,pediatric ward 24,second floor,casualty building,government medical college and hospital chhatrapati sambhaji nagar,university road,jubilee park,aurangabad 431004
Aurangabad
MAHARASHTRA 		 7977438293

gauravpandey2506@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics commitee government medical college aurangabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J96-J99||Other diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nasal septum tragal length  NTL Group: Endotracheal tube depth for insertion will be measured using NasoTragal Length(NTL):measured with a measuring tape from the collumellar base of the nose to the ear tragus, on left side for uniformity Insertion depth will be calculated as (NTL +1) cm, rounded off to the nearest 0.5cm. total duration of this intervention will be 24 months. 
Comparator Agent  Weight based formula  WBF Group : Endotracheal tube depth for insertion will be measured using Weight-based Formula: 1) Calculated as (6+weight in kg) cm 2)If current weight is birth weight, birth weight will be considered 3)If weight is less than 750g, fixation is done at 6cm 4)The calculated value will be rounded off to the nearest 0.5cm 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Neonates(28 to 40weeks) requiring Endotracheal tube placement 
 
ExclusionCriteria 
Details  1.Congenital anomalies of the airway (e.g., tracheoesophageal fistula,
congenital diaphragmatic hernia, laryngeal or tracheal stenosis)
2.Major craniofacial anomalies ((e.g., Pierre Robin sequence, cleft palate)
3.Severe chest wall deformities (e.g., pectus excavatum) may affect measurement methods like nasotragal length.
4.Vertebral abnormalities
5.Neonates already intubated prior to admission
(outborn)
6.Hemodynamic instability precluding safe transport for chest XrayParental refusal for consent
7.Parental refusal for consent. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare endotracheal tube depth prediction methods using nasotragal length and weight based formula in neonatesto determine optimal endotracheal tube position using chest xray and point care of ultrasound  after every endotracheal tube fixation techniques chest xray will be done to locate the tip of endotracheal tube. Enotracheal tube Position
Above T1, Between
T1&T2, Below T2 
 
Secondary Outcome  
Outcome  TimePoints 
chest xray
ultrasonography
number of reposition needed as per position of Endotracheal tube determined by chest xray and point of care utrasonography 		 After every endotracheal tube fixation techniques Chest X-RAY will be done
to locate the tip of endotracheal tube.
Given that the first thoracic vertebra (T1) corresponds to the tracheal
midpoint and T4 corresponds to the carina, a position between T1 and T2
represents an acceptable standard for the position of the ETT tip on chest
radiographs.
And Point of care ultrasound will be done to locate the tip of endotracheal
tube with respect to Aortic arch 
 
Target Sample Size   Total Sample Size="340"
Sample Size from India="340" 
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)   21/07/2025 
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 Yet Recruiting 
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   Endotracheal intubation is a critical and often lifesaving intervention in neonatal intensive care units (NICU), particularly for premature or critically ill newborns requiring respiratory support. Accurate determination of endotracheal tube insertion depth is crucial in neonates to prevent complications such as tube misplacement, which can lead to inadequate ventilation or injury. However, determining the optimal insertion depth for Endotracheal tube in neonates remains challenging due to their small size and anatomical variations.Hence we plan to conduct this procedure and we will compare two methods by checking the position of endotracheal tube using chest xray and point of care ultrasonography. 
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