| CTRI Number |
CTRI/2025/03/083163 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the Accuracy of Little Finger Diameter and Ultrasound Measured Subglottic Diameter for Estimating Uncuffed Endotracheal Tube Size in Children |
|
Scientific Title of Study
|
Comparitive Study of Little Finger Diameter Measurement with Ultrasonography Subglottic Diameter Measurement to Estimate the Size of the Uncuffed Endotracheal Tube in Pediatric patients
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUBRAMANI PREETHY |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Anaesthesia Department, Ground Floor, Sapthagiri Institute Of Medical Sciences And Research Centre, Navy Layout, Hesarghatta Main Road, Chikkabanavara, Bangalore,Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
9566864945 |
| Fax |
|
| Email |
pree0207@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NARENDRA BABU MC |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Anaesthesia Department, Ground Floor, Sapthagiri Institute Of Medical Sciences And Research Centre, Navy Layout, Hesarghatta Main Road, Chikkabanavara, Bangalore,Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
9900214064 |
| Fax |
|
| Email |
narendrababuchanappa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NARENDRA BABU MC |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Anaesthesia Department, Ground Floor, Sapthagiri Institute Of Medical Sciences And Research Centre, Navy Layout, Hesarghatta Main Road, Chikkabanavara, Bangalore,Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
9900214064 |
| Fax |
|
| Email |
narendrababuchanappa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri Institute Of Medical Sciences And Research Centre, Department of Anaesthesiology Ground Floor OT Complex, Navy Layout, Hesaraghatta Main Road, Chikkabanavara, Bangalore , Karnataka ,560090 ,INDIA |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute Of Medical Sciences and Research Centre |
| Address |
Sapthagiri Institute of Medical Sciences and Research Centre , 15, Hesarghatta Rd, Navy Layout, Chikkasandra, Chikkabanavara, Bengaluru, Karnataka 560090 |
| Type of Sponsor |
Private medical college |
|
|
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 Subramani Preethy |
Sapthagiri Institute Of Medical Sciences And Research Centre |
Department Of Anaesthesiology Ground Floor OT Complex, #15 Hesaraghatta Main Road, Chikkabanavara, Bangalore-560090 , Karnataka INDIA
Bangalore
KARNATAKA |
9566864945
pree0207@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute Of Medical Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pediatric population undergoing surgeries under General Anaesthesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NIL |
| Intervention |
NIL |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 physical status
2x8 years of both gender
Elective Surgeries under General Anaesthesia
Parents of children willing to give written informed consent for the study |
|
| ExclusionCriteria |
| Details |
Anomalies of face, head , neck and spine region
Children with birth history of Prematurity or low birth weight
Emergency surgeries
Obvious scars/mass/ ulcers in neck |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the correlation between little finger diameter with ultrasonographic subglottic diameter for selection of appropriate sized uncuffed Endotracheal tube as measured by Audible leak test |
5 minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
06/04/2025 |
| 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="6"
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
|
Pediatric population aged between 2-8 years fulfilling the inclusion criteria scheduled for elective surgical procedures under General anaesthesia will be considered for the study.Considering ultrasound guided subglottic diameter as the standard method for selection of Endotracheal tube size, a senior Anaesthesiologist will perform intubation and use the tube as measured by ultrasound followed by performing a leak test. Any changes made in the Endotracheal tube size and final appropriate size used will be noted.Size to side diameter of left little finger distal digit of the patient is measured using a vernier caliber. Hemodynamic parameters HR, NIBP systolic and diastolic, spo2 and EtCo2 will be compared at different times. |