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CTRI Number  CTRI/2025/03/082978 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 12/05/2026
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   Comparison of Two Blades (C-MAC Miller and Macintosh) for Intubation in Preterm Infants and Neonates 
Scientific Title of Study   Comparison of C-MAC Miller Size 0 Blade and C-MAC Macintosh Size 0 Blade for Intubation in Preterm Infants & Neonates: A Randomised Controlled 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  Renu Sinha 
Designation  professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, Room No.- 376, Dr Rajendra Prasad Centre for Ophthalmic Sciences, Aiims, New Delhi

New Delhi
DELHI
110029
India 
Phone  9810305156  
Fax    
Email  renusinha@aiims.edu  
 
Details of Contact Person
Scientific Query  
Name  Renu Sinha 
Designation  professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, Room No.- 376, Dr Rajendra Prasad Centre for Ophthalmic Sciences, Aiims, New Delhi

New Delhi
DELHI
110029
India 
Phone  9810305156  
Fax    
Email  renusinha@aiims.edu  
 
Details of Contact Person
Public Query  
Name  Renu Sinha 
Designation  professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, Room No.- 376, Dr Rajendra Prasad Centre for Ophthalmic Sciences, Aiims, New Delhi

New Delhi
DELHI
110029
India 
Phone  9810305156  
Fax    
Email  renusinha@aiims.edu  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, India, Pin-110029 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Renu Sinha  AIIMS, New Delhi  RPC OT, Department of Anesthesiology, Pain Medicine and Critical Care, New Delhi
South
DELHI 		 9810305156

renusinha@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committe, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H351||Retinopathy of prematurity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  C-MAC Macintosh  Intubation with C-MAC Macintosh size 0 blade in preterm infants and Neonates 
Comparator Agent  C-MAC Miller  Intubation with C-MAC Miller size 0 blade in preterm infants and Neonates 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Month(s)
Gender  Both 
Details  Preterm infants & neonates [from birth till 60 weeks post conceptional age (PCA) or 1 month of age]. 
 
ExclusionCriteria 
Details  1. Neonates with known craniofacial abnormalities or congenital airway malformations.
2. History of difficult intubation.
3. Hemodynamic instability or conditions contraindicating elective intubation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time to Intubation (TTI): Time from insertion of the blade in the mouth to the passage of the endotracheal tube through the vocal cords.  From the time of induction of anaesthesia till endotracheal intubation is completed. (usually 5-10 minutes from start of anaesthesia induction) 
 
Secondary Outcome  
Outcome  TimePoints 
1.Time to Best Glottic View (TTGV): Time from insertion of the blade in the mouth to achieving the best possible glottic view.
2.Time to Procedure (TTP): Time from insertion of the blade in the mouth till square shaped etCO2 tracing is seen in the monitor.
3.Percentage of glottic opening (POGO) score: Graded on a scale of 0–100% based on visualized glottis.
4.Number of intubation attempts required.
5.Ease of blade insertion, ease of ETT insertion, ease of intubation, graded on a scale of 1 (easy) to 5 (very difficult).
6.Adverse events, including desaturation , mucosal trauma, or bradycardia .
 		 From the starting time of induction of anaesthesia till completion of endotracheal intubation. (usually takes 5-10 minutes from start of induction of anaesthesia) 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/04/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

Neonatal airway management presents unique challenges due to the anatomical and physiological differences in preterm infants and neonates, such as a proportionally larger tongue, anterior larynx, and narrower airway. These features make intubation technically demanding and necessitate specialized tools. The C-MAC video laryngoscope, with its Miller and Macintosh blades, has been extensively used in adult and pediatric airway management. However, there is limited evidence comparing these blades for intubation in preterm infants and neonates. This randomised controlled study aims to evaluate and compare the effectiveness of the C-MAC Miller size 0 blade with the C-MAC Macintosh size 0 blade for endotracheal intubation in this population. After performing a pre-anesthetic check-up and obtaining consent, eligible participants will be randomised into two groups: Group Miller: Intubation with the C-MAC Miller size 0 blade and Group Macintosh: Intubation with the C-MAC Macintosh size 0 blade. In the operation theatre, routine monitors (ECG, SpOâ‚‚, NIBP) will be applied, and general anesthesia will be induced with sevoflurane. After adequate depth of anesthesia is achieved, atracurium (0.5 mg/kg) will be administered, and manual ventilation will be provided. Intubation will then be performed using the allocated blade by an experienced paediatric anaesthesiologist, following standardized techniques. The primary outcome will be the time to intubation (TTI) and secondary outcomes will include: Total time for the procedure (TTP), Glottic visualization quality (POGO score), Intubation attempts, Ease of blade, and ETT insertion and adverse events, such as desaturation (SpOâ‚‚ < 90%) or bradycardia. All intubations will be video-recorded to ensure objectivity during outcome analysis. If intubation fails after two attempts, an alternative blade will be used, and the event will be documented as a failure. This study aims to identify the optimal blade design for preterm neonatal intubation by analysing efficiency, ease of use, and safety parameters, contributing to improved clinical practices in neonatal airway management.

 
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