| CTRI Number |
CTRI/2020/10/028203 [Registered on: 01/10/2020] Trial Registered Prospectively |
| Last Modified On: |
26/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Ultrasonography For Endotracheal Tube position In Neonates |
|
Scientific Title of Study
|
Role Of Point Of Care Ultrasonography For Endotracheal Tube Placement In Neonates : A Randomized Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranaya Kumar Mall |
| Designation |
Senior Resident (Academic DM) |
| Affiliation |
ABVIMS And Dr. RML hospital |
| Address |
Department Of Neonatology, ABVIMS And Dr RML Hospital New Delhi
New Delhi
DELHI
110008
India |
| Phone |
8423839069 |
| Fax |
|
| Email |
pranayamall2011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Arti Maria |
| Designation |
Head Of Department, Department Of Neonatology |
| Affiliation |
ABVIMS And Dr. RML hospital |
| Address |
Department Of Neonatology, ABVIMS And Dr RML Hospital New Delhi
New Delhi
DELHI
110008
India |
| Phone |
9818618586 |
| Fax |
|
| Email |
artimaria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pranaya Kumar Mall |
| Designation |
Senior Resident (Academic DM) |
| Affiliation |
ABVIMS And Dr. RML hospital |
| Address |
Department Of Neonatology, ABVIMS And Dr RML Hospital New Delhi
New Delhi
DELHI
110008
India |
| Phone |
8423839069 |
| Fax |
|
| Email |
pranayamall2011@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS And RML Hospital New Delhi |
|
|
Primary Sponsor
|
| Name |
ABVIMS And RML Hospital New Delhi |
| Address |
ABVIMS And Dr RML Hospital
New Delhi
110001 |
| Type of Sponsor |
Government 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 Pranaya Kumar Mall |
department of neonatology |
ABVIMS and DrRML hospital
new delhi
New Delhi
DELHI |
8423839069
pranayamall2011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ABVIMS And Dr RML Hospital New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J962||Acute and chronic respiratory failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Method (Tochens Formula Or Weight Based Intubation Follwed By Xray Chest) |
In Conventional Method Initial Intubation Is Based On Tochens Formula That Is Weight Based Decision Of Initial Insertion Depth Of Endotracheal Tube Followed By Xray Chest To Confirm Final Tip Position.
X Ray Will Be Done Once Per Intubation. |
| Intervention |
Conventional Plus Ultrasonography Method For Endotracheal Tube Placement In Neonates |
in Neonates Requiring Invasive Mode Of Mechanical Ventilation In Our NICU Will Be Subjected To Ultrasonography Method To Complement Conventional Method For Confirmation Of Endotracheal Tube Tip Position In Neonates.
It Will Be Done Only Once Per Intubation Period Immediately After Intubation. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonates Requiring Intubation And Mechanical Ventilation As Per Clinical Indication. |
|
| ExclusionCriteria |
| Details |
Neonates With Major Upper Airway Congenital Malformation Precluding Intubation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Malposition Rate Of Endotracheal Tube In “Conventional Method†As Compared To “Conventional Plus Ultrasonography Method†Among Neonate Requiring Mechanical Ventilation. |
Till Xray Chest Post Intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| difference in turnaround time between intubation and USG and intubation and X ray |
till Xray chest post intubation |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
06/10/2020 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
optimal Position Of Endotracheal Tube Is necessary For Safe And Effective Ventilation. Initial Estimation Of Endotracheal Tube Depth To Be Inserted Is Based Upon Various Methods That Are Weight Based, Gestation Based , Vocal Cord Guide Based, Nasotragal Length Based And Suprasternal Notch Palpation Method Based. All These Methods Are Crude Estimation Methods And Frequently Needs Manipulation Of Endotracheal Tube After Getting X-ray Chest. Often These Methods Place Endotracheal Tube At Sub-optimal Position Leading To Life Threatening Complications Such As Hypoxia, Hypercarbia, Lung Collapse, Pneumothorax. Ultrasonography To Detect Endotracheal Tube Position Has Shown Very Good Correlation With X-ray Chest in Various Previous Studies. Our Present Study Will Assess The Role Of Ultrasonography To Complement Our Conventional Method (Tochen’s Plus X-ray Chest ) In Placing Endotracheal Tube At Optimal Position In Neonates Requiring Mechanical Ventilation In Our NICU. |