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CTRI Number  CTRI/2025/09/094428 [Registered on: 09/09/2025] Trial Registered Prospectively
Last Modified On: 29/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study comparing two different scoring systems namely Fremantle score and Modified Intubation Difficulty score for assessing ease of placing breathing tubes in children for surgeries under general anesthesia 
Scientific Title of Study   AN OBSERVATIONAL STUDY COMPARING FREMANTLE SCORE AND MODIFIED INTUBATION DIFFICULTY SCORE FOR EASE OF INTUBATION ON VIDEOLARYNGOSCOPY IN PEDIATRIC PATIENTS UNDERGOING SURGERIES UNDER GENERAL ANESTHESIA WITH ENDOTRACHEAL INTUBATION 
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. Visakh K Mohan 
Designation  Junior Resident 
Affiliation  BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY MEDICAL COLLEGE 
Address  Department of Anesthesiology, Third floor, BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY MEDICAL COLLEGE, PUNE-SATARA ROAD, DHANKAWADI, PUNE, MAHARASHTRA, PIN-411043, INDIA

Pune
MAHARASHTRA
411043
India 
Phone  9980315117  
Fax    
Email  kmohan.visakh001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sarita Swami 
Designation  PROFESSOR 
Affiliation  BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY MEDICAL COLLEGE 
Address  Department of Anesthesiology, Third floor, BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY MEDICAL COLLEGE, PUNE-SATARA ROAD, DHANKAWADI, PUNE, MAHARASHTRA, PIN-411043, INDIA

Pune
MAHARASHTRA
411043
India 
Phone  9822846369  
Fax    
Email  drswamisarita@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  DR VISAKH K MOHAN 
Designation  RESIDENT 
Affiliation  BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY MEDICAL COLLEGE 
Address  Department of Anesthesiology, Third floor, BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY MEDICAL COLLEGE, PUNE-SATARA ROAD, DHANKAWADI, PUNE, MAHARASHTRA, PIN-411043, INDIA

Pune
MAHARASHTRA
411043
India 
Phone  9980315117  
Fax    
Email  kmohan.visakh001@gmail.com  
 
Source of Monetary or Material Support  
BHARATI HOSPITAL AND RESEARCH CENTRE 
 
Primary Sponsor  
Name  BHARATI HOSPITAL AND RESEARCH CENTRE 
Address  BHARATI HOSPITAL AND RESEARCH CENTRE, DHANKAWADI, PUNE, 411043 
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 SARITA SWAMI  BHARATI HOSPITAL AND RESEARCH CENTRE  Department of Anesthesiology, Third Floor, BHARATI HOSPITAL AND RESEARCH CENTRE, DHANKAWADI, PUNE, 411043
Pune
MAHARASHTRA 
9822846369

drswamisarita@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BHARATI VIDYAPEETH INSTITUITIONAL ETHICAL COMMITTEE  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  Nil  Nil 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1)Patients aged between 2-8 years of age with American Society of Anaesthesiologists(ASA) Grade I & II of both sexes. 2) Patients undergoing elective surgeries under general anaesthesia  
 
ExclusionCriteria 
Details  Patients having anticipated difficult airway will be excludued like, 1)Patient having multiple facial trauma, 2) Patients having oral or nasal cavity masses, 3) Patients having midline neck swellings, 4) Patients having tracheal pathology like tracheal stenosis, tracheo esophageal fistula, tracheomalacia etc, 5) if intra operative position of patient is prone, 6) parents refusal to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare Fremantle score and modified intubation difficulty score for ease intubation on videolaryngoscopy in pediatric patients undergoing surgeries under general anesthesia with endotracheal intubation  3-5 minutes from the time of videolaryngoscopy. . 
 
Secondary Outcome  
Outcome  TimePoints 
To compare success rate of intubation in first attempt with Fremantle score & modified intubation difficulty score.  3-5 minutes from the time of videolaryngoscopy  
 
Target Sample Size   Total Sample Size="182"
Sample Size from India="182" 
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)   10/09/2025 
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="0"
Months="6"
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 obtaining approval from institutional ethical committee and informed consent from the parents ,total number of 182 patients between the age group of 2-8 years undergoing elective surgeries under general anesthesia  will be included in the study • Risk identification with detailed preoperative evaluation will be done. They will be explained the general procedure of intubation. All the patients will be kept nil by mouth for 6 hours prior to surgery. On the day of surgery patients will be brought to the operation theatre. A peripheral IV catheter was placed before entering the operating room with patients. Before induction of anaesthesia, 3 lead ECG, baseline blood pressure, mean arterial blood pressure, saturation, heart rate will be recorded in each patient. Standard monitoring of pulse rate, systolic, diastolic and mean blood pressure and saturation will be done intra-operatively. Standard protocol of General Anaesthesia will be followed in all patients as follows: 1)Pre anaesthesia check-up as per the proforma I 2) Pre-op counseling 3) General Anaesthesia induction- Premedication – Injection Glycopyrrolate 0.004mg/kg i.v, Injection Midazolam 0.05mg/kg iv. Followed by, Injection Ketamine 2mg/kg iv, Injection Fentanyl 2mcg/kg i.v and Injection Propofol 2mg/kg iv. The drugs will be diluted and given slowly. Patient will be given Inj. ATRACURIUM 0.5mg/kg , IPPV and then video-laryngoscopy will be performed. During video-laryngoscopy, Modified Intubation difficulty Score (mIDS) and Fremantle score will be noted. Also Time taken for intubation (in seconds) will a be noted. It is the time from introduction of the laryngoscope blade into the mouth to the visual appearance of capnography trace on the monitor.  Patient will be then intubated with portex(uncuffed/microcuffed/cuffed)  ETT according to calculated size. The intubation will be done by trained anaesthesiologists (after 1 year of training). Maintainance – Inj. ATRACURIUM 0.5mg/kg + IPPV close circuit + Sevoflurane. After conclusion of surgery, Patient will be reversed by Neostigmine 0.05mg/kg + Glycopyrrolate0.01mg/kg and extubation of endotracheal tube from tracheal will be performed after thorough oropharyngeal suctioning and after confirmation of spontaneous adequate regular respiration.

 
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