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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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