| CTRI Number |
CTRI/2019/03/018161 [Registered on: 19/03/2019] Trial Registered Prospectively |
| Last Modified On: |
18/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Measurement of middle finger length in childern in south indian population and its correlation with tube size which is used in anaestheisa |
|
Scientific Title of Study
|
Prediction of endotracheal tube size for pediatric patients
from the length of the middle finger in South Indian population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramya Lakhsmi Kamlekar |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Anaesthesiology,
Kasturba Medical College,
Manipal ,Udupi District,
Udupi
KARNATAKA
576104
India |
| Phone |
9032225503 |
| Fax |
|
| Email |
ramyakamlekar99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Malavika Kulkarni |
| Designation |
MBBS, MD |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
ASSOCIATE PROFESSOR
Department of Anaesthesiology,
Kasturba Medical College,
Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9844241620 |
| Fax |
|
| Email |
malavika.kulkarni@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DR Malavika Kulkarni |
| Designation |
MBBS, MD |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
ASSOCIATE PROFESSOR
Department of Anaesthesiology,
Kasturba Medical College,
Manipal.
Hassan
KARNATAKA
576104
India |
| Phone |
9844241620 |
| Fax |
|
| Email |
malavika.kulkarni@manipal.edu |
|
|
Source of Monetary or Material Support
|
| kasturba medical college manipal |
|
|
Primary Sponsor
|
| Name |
Ramya Lakshmi Kamlekar |
| Address |
Department of Anaesthesiology,
Kasturba Medical College,
Manipal |
| Type of Sponsor |
Other [kasturba 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 |
| RAMYA LAKSHMI KAMLEKAR |
Kasturba Medical College |
department of anaesthesiology
Udupi
KARNATAKA |
9032225503
ramyakamlekar99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital - Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
asaps 1 and 2 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Age 0-18 years
Undergoing any surgery requiring General Anaesthesia with endotracheal intubation
Use of muscle relaxants before intubation
American society of anesthesiologists physical status class 1 and 2
|
|
| ExclusionCriteria |
| Details |
American Society of Anesthesiologists physical status classification of 3 or beyond.
Patients requiring nasal intubation.
Patients with predicted difficult airway
Children with known airway or finger abnormalities
Known allergy to any anesthetic medications
In case of leak at 10cm H2O pressure (small size tube) If the attending anesthetist does not change it till leak is achieved between 10 and 25 cmH2O and uses a throat pack to seal the leak.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The child may or may not get benefit from participating in this study. This study will be helpful in creating a predictable formula for selection of appropriate size endotracheal tube which may help other patients in future |
september 2020 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| correlation and formulation of formula for endotracheal tube internal diameter size estimation in paediatric population for furture |
september 2020 |
|
|
Target Sample Size
|
Total Sample Size="325"
Sample Size from India="325"
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)
|
20/03/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Choosing​ the correct endotracheal tube size is important in paediatric anaesthesia. The subglottic diameter being the narrowest diameter of the paediatric upper airway plays an important role in appropriate ETT size selection . Thus predicting internal diameter of tracheal tube using middle finger length is clearly advantageous in emergency situation. The benefit of reduced tracheal tube exchanges multiple attempts in intubating, decreased risk of postoperative laryngospasm bronchospasm, and laryngeal edema. Decreases risk associated with a tracheal tube with smaller internal diameter such as increased airway resistance, increased risk of tracheal tube blockade by secretions. |