| CTRI Number |
CTRI/2024/04/066090 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
20/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare the accuracy of different methods of endotracheal tube insertion in neonates. |
|
Scientific Title of Study
|
Calculation of Endotracheal tube insertion length in neonates-a comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshit |
| Designation |
Post graduate resident Department of Paediatrics Kasturba Hospital Manipal |
| Affiliation |
Kasturba Hospital Manipal |
| Address |
Department of Paediatrics Kasturba Hospital Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9466200001 |
| Fax |
|
| Email |
asingh838@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sheila S Mathai |
| Designation |
Professor and HOD, Department of Neonatology, Kasturba Hospital Manipal |
| Affiliation |
Kasturba Hospital Manipal |
| Address |
Department of Neonatology, Kasturba Hospital Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9930954139 |
| Fax |
|
| Email |
sheilamathai@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Leslie E. Lewis |
| Designation |
Professor and HOD, Department of Paediatrics, Kasturba Hospital, Manipal |
| Affiliation |
Kasturba Hospital Manipal |
| Address |
Department of Paediatrics, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9449208476 |
| Fax |
|
| Email |
leslie.lewis@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital Manipal, Udupi, Karnataka, India. Pin code-576104 |
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [SELF] |
|
|
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 Leslie Lewis |
Kasturba Hospital Manipal |
NICU, Department of Neonatology, Kasturba Hospital Manipal
Udupi
KARNATAKA |
9449208476
Leslie.lewis@manipal.edu |
|
|
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 |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
ALL INTUBATED NEONATES WITH POST INTUBATION XRAY ADMITTED IN NICU KASTURBA HOSPITAL MANIPAL |
|
| ExclusionCriteria |
| Details |
Hydrops Foetalis
Marked edema/ Injury to Face
Congenital anomalies of face.
Dysmorphic neonates. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the accuracy of methods of endotracheal tube insertion. |
Within 6 hrs of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine variations in accuracy of different methods with birth weight, gestational age & SGA status. |
Within 6 hours of intubation |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
02/05/2024 |
| 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 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
|
All intubated neonates with post intubation Xray will be assessed for eligibility. Tochen formula will be calculated for all neonates in study. (weight+6 to the nearest of 0.5cm), which is standard method of calculation in our unit before intubation. Consent for measurements will be taken from parents of eligible neonates. Details of case with be noted. All babies will be assessed within 6 hours of intubation. Facial measurements will be done using non stretchable disposable tapes. NTL, NsTL and CTL distances to the nearest 0.5 cm will be recorded for each neonate. Position of end of ETT (actual and optimal) will be determined from CXRay measurements. Lower end of T2 will be taken for calculation of the optimal position of the ET. Xray is standard method use to see if endotracheal tube is correctly placed. Difference between optimal and actual position will be calculated for each case in mm. Measurements will be confirmed by faculty members. If baby is intubated twice during hospital stay, each intubation will be taken as separate reading. Weight will be measured on electronic weighing scale to an accuracy of 10 grams. GA will be assessed by NBS and records. |