| CTRI Number |
CTRI/2024/10/075443 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To know the proper length of airway securing tube by measuring kids anatomical parameters like tragus length,foot length, sternum length, thyromental distance and so on. |
|
Scientific Title of Study
|
Association of Oro-tracheal tube inserted depth with anatomi-cal parameters among infants |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pappu Kumar Mahato |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
department of anaesthesia, Dhanvanthri Nagar,Puducherry jipmer hostel complex , harvey house 2,room no. 211, jipmer, pondycherry Pondicherry PONDICHERRY 605006 India |
| Phone |
8797654097 |
| Fax |
|
| Email |
dr.mahato111@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Lenin Babu Elakkumaran |
| Designation |
Proffesor and Head |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of anaethesia, Dhanvanthri Nagar,Puducherry
Pondicherry PONDICHERRY 605006 India |
| Phone |
9487981140 |
| Fax |
|
| Email |
dr.lenin@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Pappu Kumar Mahato |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
department of anaesthesia, Dhanvanthri Nagar,Puducherry
Pondicherry PONDICHERRY 605006 India |
| Phone |
8797654097 |
| Fax |
|
| Email |
dr.mahato111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal institute of post graduate medical education and research |
|
|
Primary Sponsor
|
| Name |
Jawaharlal institute of post graduate medical education and research |
| Address |
jawaharlal institute of post graduate medical education and research,(JIPMER), pondicherry, puducherry |
| 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 Pappu Kumar Mahato |
JIPMER HOSPITAL |
NICU, PICU ,Pediatrics surgery OT, Emergency surgery OT; Pediatrics department ; Infantology devision,
jipmer Hospital Pondicherry PONDICHERRY |
8797654097
dr.mahato111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR OBSERVATIONAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J969||Respiratory failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
Neonates and infants who undergoes an elective / emergency orotracheal intubation with tip of the ET tube in clinically effective position based on ET tube depth marker at the level of glottis. |
|
| ExclusionCriteria |
| Details |
Infants with congenital anomalies of head and neck that complicate the ET tube intubation procedure are excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the inserted depth of ET tube, nasotragal length, sternal length, foot length, thyromental length and manubriosternal junction to mental length and find out appropriate formulae for estimating the insertion depth of endotracheal tube using those parameters. |
30 minutes to 1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to develop a regression model to predict ET tube insertional depth using the anatomical parameters |
at the time of intubation |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
25/10/2024 |
| 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 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
|
:
Endotracheal intubation is a common procedure done in infants and
neonates requiring respiratory support. More often this procedure is done in
emergency setting, where predicting data such as weight of the patient may not
be easy. After intubation, it is a standard medical practice to confirm the
clinically effective position of the tip of the ET tube initially by chest
auscultation and later by EtCO2. Optimal Endotracheal (ET) tube positioning is
important, and the ideal position is halfway between vocal cord and carina. If
an ET tube is placed too high accidental extubation may occur, if placed too low then endobronchial intubation, poor
ventilation, atelectasis or pneumothorax may occur. The initial clinical assessment of
the appropriate intubation depth is to auscultate equal air entry to the bilateral lungs. Nevertheless,
it lacks a quantitative or qualitative change of breathing sound detected on
auscultation, despite 1cm downward displacement of the ET tube tip into the
main bronchus; one study indicated that up to 60% of endobronchial intubations
were by equal breath sound auscultation. Thus, several methods have
been reported to determine the proper ET tube depth for intubation and the accurate ET tube tip
position, such as the well-known 7-8-9 Rule, body parameters as a predictor,
the manufacturer’s markings on the tube tip and sonogram. Also, a number of
nomograms are available to predict this depth from external body measurements
such as weight, head circumference, crown-heel or crown-rump length. However,
many of these studies have their limitations. |