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CTRI Number  CTRI/2023/08/056319 [Registered on: 09/08/2023] Trial Registered Prospectively
Last Modified On: 08/08/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Observational non interventional 
Study Design  Single Arm Study 
Public Title of Study   Study of influence of ventilatory parameters on the clinical outcome in children on respiratory support (mechanical ventilation).  
Scientific Title of Study   Prospective observational study to find association of DP and mechanical power measured in first 36-hours of intubation with 28-day ventilator-free days in a heterogeneous group of mechanically ventilated children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Farhan Shaikh 
Designation  Consultant Pediatric Intensivist 
Affiliation  Rainbow Childrens hospital, Road no 2, Banjara Hills, Hyderabad 
Address  Pediatric Intensive Care Unit II Floor Rainbow Childrens hospital, Road no2, Banjara Hills Hyderabad TELANGANA 500034 India

Hyderabad
TELANGANA
500034
India 
Phone  9866007602  
Fax    
Email  farhanshaikh74@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Farhan Shaikh 
Designation  Consultant Pediatric Intensivist 
Affiliation  Rainbow Childrens hospital, Road no 2, Banjara Hills, Hyderabad 
Address  Pediatric Intensive Care Unit II Floor Rainbow Childrens hospital, Road no2, Banjara Hills Hyderabad TELANGANA 500034 India

Hyderabad
TELANGANA
500034
India 
Phone  9866007602  
Fax    
Email  farhanshaikh74@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Farhan Shaikh 
Designation  Consultant Pediatric Intensivist 
Affiliation  Rainbow Childrens hospital, Road no 2, Banjara Hills, Hyderabad 
Address  Pediatric Intensive Care Unit II Floor Rainbow Childrens hospital, Road no2, Banjara Hills Hyderabad TELANGANA 500034 India

Hyderabad
TELANGANA
500034
India 
Phone  9866007602  
Fax    
Email  farhanshaikh74@gmail.com  
 
Source of Monetary or Material Support  
Rainbow Childrens Hospital, Road#2, Banjara Hills, Hyderabad 
 
Primary Sponsor  
Name  Dr Farhan Shaikh 
Address  Rainbow Childrens hospital,Road no2, Banjara Hills Hyderabad TELANGANA 500034 
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 Farhan Shaikh Dr Mounika  Rainbow Childrens Hospital, road no 2, Bnajara Hills  Rainbow Childrens Hospital, road no 2, Banjara Hills
Hyderabad
TELANGANA 		 9866007602

farhanshaikh74@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rainbow Children s Hospital EC for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  All patients intubated for respiratory failure and ventilated on Pressure-control mode of ventilation shall be included in the study from 1-month age till 18-years age. 
 
ExclusionCriteria 
Details  1. Children with neuromuscular diseases,
2. Those who got extubated within 24-hours of intubation.
3. Those who needed HFOV or ECMO within first 36 hours of admission
4. Those who got intubated and ventilated in outside hospitals for more than 12 hours
5. Children with immunodeficiency
6. Post operative children following Liver or Renal Transplants
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Driving pressure and Mechanical Power measured in first 36-hours of intubation with 28-day ventilator-free days in a heterogeneous group of mechanically ventilated children  Driving pressure and Mechanical Power measured in first 36-hours of intubation with 28-day ventilator-free days. 
 
Secondary Outcome  
Outcome  TimePoints 
calculate Mechanical Power Normalized to body weight (NorMP) and Mechanical Energy and their association with 28-days ventilator free days.
Association with other outcome parameters like PICU length of stay and mortality will be studied.
Sub group analysis amongst different disease categories (normal lung, restrictive lung disease, obstructive lung disease, mixed disease) will also be performed
 		 at 12 and 24 hours 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   21/08/2023 
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   not yet pubished 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

•      Children included in the study shall be ventilated on PC mode and sedated as per unit policy.

•      Consent shall be taken

•      Paralysis will be as per unit policy and treating clinician’s discretion

•      The PEEP setting shall be as per the underlying lung condition and treating consultant’s discretion.

•      Setting of Tidal Volume (Vt), PIP, Respiratory Rate (RR), Inspiratory Time (Ti) etc will eb as per the Pediatric Mechanical Ventilation Consensus Conference (PEMVECC)6 guidelines and for pARDS patients as per the PALICC guidelines.

•      The mechanical ventilators used will be GE CARESCAPE R860. Software version 10 (infant Pediatric and adult), Manufacturer: Datex Ohmeda Inc. Made in USA. And MAQUET (GETINGE Group) SERVO-i v8.0 (infant and Pediatric) (Manufacturer. Maquet critical care AB. Sweden).

•      In both GE CARESCAPE R860 and MAQUET Servo-I and Servo-S ventilators, circuit compliance, resistance and leak are measured and compensated each time at the initiation of the ventilation. In both the ventilators the inspiratory tidal volume (VTi) is measured by the inspiratory sensor and displayed on the screen of the ventilators. In both the ventilators the inspiratory flow sensors are automatically zeroed each time when the ventilator is started.

•      Also, whenever possible, using the E –sCOVX module, End Expiratory Lung (EELV) Volume and Functional Residual Capacity (FRC) estimation will be done and strain shall be calculated at 12 hrs and 24-36 hours of ventilation.

In our unit all the ventilators undergo preventive maintenance and calibrations once every year as per the manufacturer recommendations


 
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