| CTRI Number |
CTRI/2024/08/072170 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Using a multimodal method to predict the results of weaning in children on breathing machine |
|
Scientific Title of Study
|
Predicting weaning outcomes in mechanically ventilated children- a multimodal approach |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddhartha Shankar Pati |
| Designation |
DrNB student |
| Affiliation |
St johns medical college hospital |
| Address |
Department of paediatric intensive care
St Johns medical college hospital
John Nagar, Koramangala, Bengaluru
Bangalore KARNATAKA 560034 India |
| Phone |
0809383745 |
| Fax |
|
| Email |
siddharthashankarpati@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Lalitha A V |
| Designation |
Professor and Head Of The Department |
| Affiliation |
St Johns medical college hospital |
| Address |
Department of paediatric intensive care
St Johns medical college Hospital
John Nagar, Koramangala, Bengaluru
Bangalore KARNATAKA 560034 India |
| Phone |
9448461673 |
| Fax |
|
| Email |
drlalitha03@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Siddhartha Shankar Pati |
| Designation |
DrNB student |
| Affiliation |
St Johns medical college hospital |
| Address |
Department of paediatric intensive care
St Johns medical college Hospital
John Nagar, Koramangala, Bengaluru
Bangalore KARNATAKA 560034 India |
| Phone |
0809383745 |
| Fax |
|
| Email |
siddharthashankarpati@gmail.com |
|
|
Source of Monetary or Material Support
|
| St Johns medical college hospital
Bangalore
Karnataka
India
Pin 560034 |
|
|
Primary Sponsor
|
| Name |
Siddhartha Shankar Pati |
| Address |
Department of paediatric intensive care
St Johns medical college hospital
Bangalore, 560034
Karnataka
India |
| 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 Siddhartaha Shankar Pati |
St Johns medical college hospital, koramangala |
Department of pediatric intensive care Bangalore KARNATAKA |
8093836745
siddharthashankarpati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, ST JOHNS MEDICAL COLLEGE, BANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.All children requiring mechanical ventilation for a minimum of 48 hours
2. Children aged more than 30 days of age to 18 years of age |
|
| ExclusionCriteria |
| Details |
1.Patients with neuromuscular disease or diaphragmatic paralysis
2.Patients with tracheostomy
3.Patients who undergone surgical operations especially abdominal and thoracic operation
4.Patients with pneumothorax, pneumomediastinum, thoracostomy, chest tube or chest injuries that prevent ultrasound
5.Patients with pleural lesions or pleurodesis
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To predict weaning outcomes in mechanically ventilated children using a multimodal approach |
Prior to extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the utility of trans thoracic ultrasonography & weaning indices in predicting post extubation distress/failure in mechanically ventilated children
2. To compare between lung aeration score, diaphragmatic indices, cardiovascular dysfunction, & CROP index/RSBI as predictors of weaning from mechanical ventilation
|
Prior to extubation |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/08/2024 |
| Date of Study Completion (India) |
15/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This Prospective Observational study will be performed at St John’s medical college hospital. The children from 1 months of age to 18 years of age meeting the inclusion criteria will be enrolled in the study after taking informed consent from surrogate. Variables like Demographic details, clinical details, diagnosis for all patients at admission to PICU. Clinical and laboratory data, details of mechanical ventilation and ventilator setting will be recorded daily in patient proforma forms while the participant is in the PICU. The enrolled children satisfying eligibility criteria will undergo spontaneous breathing trial (SBT) daily. Those who met eligibility criteria for performing SBT are subjected to SBT by changing the ventilator mode to pressure support ventilation (PSV) or by T-piece trial. During SBT, lung ultrasonography (all areas of lungs), diaphragm ultrasonography (Diaphragm thickening fraction, Diaphragmatic excursion), echocardiography (left ventricular systolic function, left ventricular end-diastolic pressure estimation) will be done. Observation and data collection of criteria for SBT, failure of SBT, criteria for post extubation respiratory failure, criteria for reintubation will be done. Patients were monitored during this period for any signs of failure of SBT. Weaning will be continued irrespective of USG results. If failure of SBT, MV will be continued and checking for the eligibility criteria for performing SBT will be done after 24 hours. Patients will be monitored for extubation failure for 48 hours. |