| 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
|
|
|
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
|
|
|
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. |