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CTRI Number  CTRI/2026/03/106466 [Registered on: 18/03/2026] Trial Registered Prospectively
Last Modified On: 12/07/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two methods of inserting a breathing device in children during anaesthesia: standard digital method versus Macintosh laryngoscope guided method for better placement. 
Scientific Title of Study   Comparison between standard digital insertion and Macintosh direct laryngoscope guided technique of ProSeal laryngeal mask airway insertion in children: a double blind randomized 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  Harshikha Goel  
Designation  Post Graduate Trainee 
Affiliation  Institute of Post Graduate Medical Education and Research and SSKM Hospital 
Address  Department Of Anaesthesiology, 244 A J C Bose Road, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  9830087515  
Fax    
Email  harshikhagoel96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohanchandra Mandal 
Designation  Professor 
Affiliation  Institute Of Post Graduate Medical Education And Research And SSKM Hospital 
Address  SSKM Hospital Department of Anaesthesiology 244 A J C Bose Road Kolkata 700020

Kolkata
WEST BENGAL
700020
India 
Phone  9433072820  
Fax    
Email  drmcmandal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mohanchandra Mandal 
Designation  Professor 
Affiliation  Institute Of Post Graduate Medical Education And Research And SSKM Hospital 
Address  SSKM Hospital Department of Anaesthesiology 244 A J C Bose Road Kolkata 700020

Kolkata
WEST BENGAL
700020
India 
Phone  9433072820  
Fax    
Email  drmcmandal@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Institute of Post Graduate Medical Education and Research and SSKM Hospital 
Address  Department Of Anaesthesiology Institute Of Post Graduate Medical Education And Research and SSKM Hospital 244 A J C Bose Road Kolkata West Bengal 700020 India 
Type of Sponsor  Government 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 
Harshikha Goel  Institute Of Post Graduate Medical Education And Research And SSKM Hospital  Department Of Anaesthesiology Institute Of Post Graduate Medical Education And Research And SSKM Hospital, 244 A J C Bose Road, Kolkata, 700020
Kolkata
WEST BENGAL 		 9830087515

harshikhagoel96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGME and R Research Oversight Committee Institutional Ethics Committee Kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Macintosh Direct Laryngoscope Guided ProSeal Laryngeal Mask Airway Insertion  Insertion of ProSeal Laryngeal Mask Airway using Macintosh direct laryngoscope guided technique in paediatric patients undergoing elective surgery under general anaesthesia in order to compare its effectiveness with the standard digital insertion technique with respect to ease of insertion, number of attempts required, insertion time and airway sealing pressure. Total duration of intervention is approximately One to Two minutes during induction of general anaesthesia. 
Comparator Agent  Standard Digital ProSeal Laryngeal Mask Airway Insertion  Insertion of ProSeal Laryngeal Mask Airway using the standard digital insertion technique in paediatric patients undergoing elective surgery under general anaesthesia for comparison of ease of insertion, number of attempts required, insertion time and airway sealing pressure with the Macintosh direct laryngoscope guided technique. Total duration of intervention is approximately One to Two minutes during induction of general anaesthesia. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. ASA physical status 1 and 2
2. Aged between 2 to 12 years of age of either sex
3. Patients undergoing urethroplasty, orchidopexy, hernia repair, circumcision, cystoscopy with fulguration of posterior urethral valve and any other superficial abdominal surgery such as excision of umbilical granuloma, excision of sebaceous cyst or lipoma under general anaesthesia
4. Anticipated duration of surgery should be less than 2 hours 
 
ExclusionCriteria 
Details  1. Refusal to consent
2. Known case of difficult airway
3. History of allergy to study drugs
4. Patients having cardiorespiratory disease or oropharyngeal pathology
5. Diseases related to cervical spine
6. Aspiration risk
7. If patients require ventilator support postoperatively
8. Surgery with anticipated duration of more than 2 hours will be excluded from the study 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of children with optimal placement of ProSeal Laryngeal Mask Airway in standard digital blind insertion method versus Macintosh direct laryngoscope guided technique  Immediately after insertion of ProSeal Laryngeal Mask Airway 
 
Secondary Outcome  
Outcome  TimePoints 
Procedure time, number of insertion attempts, oropharyngeal leak pressure, ease of gastric tube placement & adverse events, if any, such as blood stain over LMA on removal; hoarseness, cough at 1 hour in the postoperative period.  During insertion of ProSeal Laryngeal Mask Airway, immediately after placement & at 1 hour postoperative period. 
 
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)   01/05/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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   ProSeal Laryngeal Mask Airway is commonly used for airway management during general anesthesia in children. However insertion using the standard digital blind technique may sometimes result in suboptimal positioning due to the bulky tip and soft cuff of the device. Direct visualization using a Macintosh laryngoscope may help improve placement of the device. This randomized double blind interventional study aims to compare the success rate of correct placement of ProSeal Laryngeal Mask Airway between the standard digital blind insertion technique and the Macintosh direct laryngoscope guided technique in pediatric patients undergoing elective surgery under general anesthesia. Secondary outcomes include procedure time number of insertion attempts oropharyngeal leak pressure ease of gastric tube placement and adverse events in the postoperative period. The study hypothesizes that the laryngoscope guided technique will result in a higher proportion of correct placement compared with the standard digital insertion technique. 
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