| CTRI Number |
CTRI/2025/01/079264 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to predict extubation success using diaphragm ultrasound |
|
Scientific Title of Study
|
A prospective observational study to determine the ultrasonographic assessment of diaphragm function as a predictor of extubation success in ventilated neonates in the NICU |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anurag Sanjeev Pikle |
| Designation |
Senior Resident |
| Affiliation |
Bharati Vidyapeeth, Pune |
| Address |
NICU, Bharati Hospital, Dhanakavadi, Katraj, Pune
Pune
MAHARASHTRA
411046
India |
| Phone |
9731631701 |
| Fax |
|
| Email |
pikle.anurag94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeep Suryawanshi |
| Designation |
Professor and Head |
| Affiliation |
Bharati Vidyapeeth, Pune |
| Address |
NICU, Bharati Hospital, Dhanakavadi, Katraj, Pune
MAHARASHTRA
411046
India |
| Phone |
9731631701 |
| Fax |
|
| Email |
drpradeepsuryawanshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anurag Sanjeev Pikle |
| Designation |
Senior Resident |
| Affiliation |
Bharati Vidyapeeth, Pune |
| Address |
NICU, Bharati Hospital, Dhanakavadi, Katraj, Pune
MAHARASHTRA
411046
India |
| Phone |
9731631701 |
| Fax |
|
| Email |
pikle.anurag94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed University Medical College, Dhanakavadi, Pune, PIN 411043, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Deemed University Medical College Pune |
| Address |
Bharati Vidyapeeth Deemed University Medical College, Dhanakavadi, Pune, PIN 411043, Maharashtra, India. |
| 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 |
| Dr Anurag Sanjeev Pikle |
Bharati Vidyapeeth Deemed University Medical College |
NICU, Department of Neonatology, Bharati Vidyapeeth Deemed University Medical College, Dhanakavadi, Pune, PIN 411043, Maharashtra, India.
Pune
MAHARASHTRA |
9731631701
pikle.anurag94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P229||Respiratory distress of newborn, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All neonates admitted to NICU requiring mechanical ventilation for at least 48 hours of life, and planned for extubation as determined by the clinical team |
|
| ExclusionCriteria |
| Details |
1. Major life- threatening congenital malformations, major chromosomal anomalies
2. Major congenital heart diseases or lung disorders
3. Congenital anomalies related to the diaphragm as diaphragmatic hernias, and diaphragmatic paralysis
4. Pleural effusion or Pneumothorax with or without an intercostal drain in situ
5. Neonatal encephalopathy
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the ultrasonographic assessment of diaphragm function as a predictor of extubation success in ventilated neonates in the NICU |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the predictive accuracy of ultrasonographic assessment of diaphragm function and ultrasound assessment of the lung (lung score) for successful extubation
2. To develop a prediction model for determining successful extubation based on diaphragm function, lung ultrasound score and ratio of Oxygen Saturation to fraction of inspired Oxygen (SpO2:FiO2). |
48 hours after extubation |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
11/11/2025 |
| 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="6"
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
|
We hypothesize that assessment of diaphragmatic
dimensions and excursion, before planned extubation in neonates, may be helpful
in predicting successful extubation of infants from mechanical ventilation. We
further hypothesize that a combination of diaphragmatic function assessment, in
association with lung sonography and the ratio of Oxygen Saturation to fraction
of inspired Oxygen (SpO2:FiO2) would be a good predictor
to success of extubation. We aim to evaluate
the diaphragmatic dimensions and excursion in ventilated neonates prior to
extubation, and create a prediction model for extubation success, based on
diaphragm function, lung score and SF ratio as a predictor for success of
extubation |