| CTRI Number |
CTRI/2019/05/019427 [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
|
Locating the nasogastric tube using ultrasound technology |
|
Scientific Title of Study
|
Randomized Control Trial to Compare Ultrasound guided Naso/Orogastric
Tube Placement As Compared To Standard Naso/Orogastric 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, Gujarat.
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, Gujarat.
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, Gujarat.
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 |
Department 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, First Floor, Department of Pediatrics, 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 |
The depth of the Naso/ Orogastric Tube would be calculated by calculating the distance between nose- ear and xiphoid and the insertion would be ensured by doing auscultation of left upper quadarant of abdomen while insufflating 2 cc of air. This would be followed by getting a chest Xray to confirm the Naso/Orogastric tube location and depth as per the current unit protocol.
- Ideal position will be defined as having all apertures of the Naso/ Orogastric Tube in the stomach. Misplacement would be defined as having any apertures of the Naso/ Orogastric Tube outside the stomach (either in the esophagus, pylorus, deodenum).
|
| Intervention |
Nasogastric Tube Localization Ultrasonically |
The depth of the Naso/ Orogastric Tube would be calculated by calculating the distance between nose- ear and xiphoid and the insertion would be ensured by doing auscultation of left upper quadarant of abdomen while insufflating 2 cc of air. Neonates in the intervention group would have bedside ultrasonography to ascertain Naso/ Orogastric Tube position in the stomach. This would be followed by getting a abdomen Xray to confirm the Naso/ Orogastric Tube location as per the current unit protocol. Bedside point of care ultrasound being rapid, it should not take more than few minutes to complete the intervention while we await Xray to be done by the Xray technician. If in case the Ultrasonography is not complete till the arrival of Xray technician then we will not delay the Xray procedure. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
90.00 Day(s) |
| Gender |
Both |
| Details |
24 to 42 weeks neonates |
|
| ExclusionCriteria |
|
|
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 localization of NGT 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will publish once study completed. No study published so far |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Through this study, we will ascertain whether point of care ultrasound can be a useful tool to determine correct Naso/ Orogastric Tube placement. This study may change the current practice of confirming Naso/ Orogastric Tube placement confirmation in neonates. |