| CTRI Number |
CTRI/2019/05/019429 [Registered on: 29/05/2019] Trial Registered Prospectively |
| Last Modified On: |
29/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Placement of tube in the windpipe and locating its position using ultrasound technology. |
|
Scientific Title of Study
|
Randomized Control Trial To Compare Ultrasound localization of Endo-Tracheal Tube Placement As Compared To Standard Endo-Tracheal Tube Placement in Neonates |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Somashekhar Nimbalkar |
| Designation |
Professor of Pediatrics |
| Affiliation |
Pramukhswami Medical College |
| Address |
Department Of Pediatrics, Pramukhswami Medical College, Karamsad, Anand.
Gokalnagar, Karamsad, Anand
Anand
GUJARAT
388325
India |
| Phone |
9825087842 |
| Fax |
|
| Email |
somu_somu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Somashekhar Nimbalkar |
| Designation |
Professor of Pediatrics |
| Affiliation |
Pramukhswami Medical College |
| Address |
Department Of Pediatrics, Pramukhswami Medical College, Karamsad, Anand.
Gokalnagar, Karamsad, Anand
GUJARAT
388325
India |
| Phone |
9825087842 |
| Fax |
|
| Email |
somu_somu@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Somashekhar Nimbalkar |
| Designation |
Professor of Pediatrics |
| Affiliation |
Pramukhswami Medical College |
| Address |
Department Of Pediatrics, Pramukhswami Medical College, Karamsad, Anand.
Gokalnagar, Karamsad, Anand
GUJARAT
388325
India |
| Phone |
9825087842 |
| Fax |
|
| Email |
somu_somu@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Pramukhswami Medical College |
|
|
Primary Sponsor
|
| Name |
Pramukhswami Medical College |
| Address |
Deparment Of Pediatrics, Pramukhswami medical College, Karamsad,Anand, Gujarat |
| 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 |
| Dipen Patel |
Pramukhswami Medical College |
NICU, Shree Krishna Hospital and Pramukhswami Medical College, Karamsad, Anand, Gujarat
Anand
GUJARAT |
9825331453
dipen_patel258@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE - 2 H M PATEL CENTRE FOR MEDICAL CARE AND EDUCATION, KARAMSAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
In the control group Endo-Tracheal Tube would be placed as per the current protocol. Saturations and heart rate will be continuously monitored and in case of doubt regarding the correct ETT insertion/ positioning the ETT will be removed followed by bag & mask to improve oxygenation/vitals and reattempt of ETT placement by senior physician/ fellow. Following this as is done by protocol X ray will be done to confirm localisation.
|
| Intervention |
Endotracheal Tube localisation Ultrasonographically |
Endotracheal Intubation would be followed by auscultation and confirmation of equal breath sounds in both groups. Saturations and heart rate will be continuously monitored and in case of doubt regarding the correct ETT insertion/ positioning the ETT will be removed followed by bag & mask to improve oxygenation/vitals and reattempt of ETT placement by senior physician/ fellow. Neonates would have bedside ultrasonography to ascertain Endo-Tracheal Tube position in the trachea (below vocal cord, at T2-T3) and the depth after auscultation and confirmation of equal breath sounds. Sonosite MicroMaxx portable US machine with probe of 5 to 8 MHz frequency will be used to identify the ET tip level. Pre-warmed gel will be applied on the probe and kept on baby using high parasternal view. Arch of aorta will be visualized and subsequently ET tip will be identified after producing a gentle motion of less than 0.5 cm ensuring that the ET was not displaced. Distance of the ET tip from superior border of aortic arch will be measured and noted. The videos of measurement done on machine will be recorded and stored in flashcard of US machine. Time taken to confirm ET position by US after intubation will be noted. A chest X ray to confirm the Endo-Tracheal Tube location would be done in both groups as per the current unit protocol |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
90.00 Day(s) |
| Gender |
Both |
| Details |
24 to 42 weeks of neonates |
|
| ExclusionCriteria |
|
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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 |
| accurate localisation of ETT by Ultrasonography |
end of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| time to localise |
end of procedure |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
28/06/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
will publish once study is completed.no study is published so far. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
When a neonate requires intubation , we confirm that tube inserted is in its proper place by using xray method. A lots of time is spent in confirmation by X ray Method. By This research we want to compare the ability of USG in confirming postition of tube as compared to X ray method. By Doing so we may able to design better methods of tube confirmation in Future.Same time in confirming tube position prevent complication of ill positioning of tube.
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