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CTRI Number  CTRI/2025/03/082865 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 19/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two different suction techniques in mechanically ventilated patients by evaluating the incidence of pneumonia.  
Scientific Title of Study   Incidence of ventilator associated pneumonia in open tracheal suction system versus closed tracheal suction system in mechanically ventilated children, An open label randomized controlled trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajwant Singh Gautam 
Designation  MD Resident  
Affiliation  All India Institute of Medical Sciences Jodhpur 
Address  Room no 212, postgraduate hostel, All India Institute of Medical Sciences Jodhpur Rajasthan, India,

Jodhpur
RAJASTHAN
342005
India 
Phone  8931051245  
Fax    
Email  aloksinghgautam97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Daisy Khera  
Designation  Professor 
Affiliation  All India Institute of Medical Sciences Jodhpur 
Address  Department of Pediatrics, All India Institute of Medical Sciences,Jodhpur,Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  8931051245  
Fax    
Email  daisykhera78@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rajwant Singh Gautam 
Designation  MD Resident 
Affiliation  All India Institute of Medical Sciences Jodhpur 
Address  Room no 212, postgraduate hostel, All India Institute of Medical Sciences Jodhpur Rajasthan India,

Jodhpur
RAJASTHAN
342005
India 
Phone  8931051245  
Fax    
Email  aloksinghgautam97@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Jodhpur, Rajasthan, 342005 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Jodhpur  
Address  All India Institute of Medical Sciences, Jodhpur, Rajasthan, 342005 
Type of Sponsor  Research institution and hospital 
 
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 Rajwant Singh Gautam  All India Institute of Medical Sciences, Jodhpur  All India Institute of Medical Sciences, Jodhpur, Rajasthan, 342005
Jodhpur
RAJASTHAN 
8931051245

aloksinghgautam97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences , Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 2||Placement,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Closed tracheal suction system   Patients enrolled in this study will have a closed suction unit. Whenever suction is needed, the knob will be opened, and the suction catheter will be inserted into the endotracheal tube. After suctioning is complete,the suction catheter will be removed and the knob will be closed. 
Comparator Agent  Open tracheal suction system  Patients enrolled in this study will have an open suction system. Whenever suction is required, the ventilator will be disconnected from the endotracheal tube, a new suction catheter will be inserted for suctioning, and then the endotracheal tube will be reconnected to the ventilator. 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  17.00 Year(s)
Gender  Both 
Details  1)Children between one month to 17 years receiving mechanical ventilation for ≥48 hours.
2)Parents or guardians giving informed written consent for enrollment of child into study.
 
 
ExclusionCriteria 
Details  Children who are transferred to our hospital already intubated.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of ventilator associated pneumonia after 48 hour of endotracheal intubation in pediatric patients randomly allocated to OTSS versus CTSS.
 
To compare the incidence of ventilator associated pneumonia after 48 hour of endotracheal intubation in pediatric patients randomly allocated to OTSS versus CTSS.
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the duration of mechanical ventilation   At 4 weeks, earlier/later until the child is intubated 
To compare the PICU mortality in each group  At 4 weeks, earlier/later until the child is discharged from PICU 
To compare the hospital mortality in each group  At 4 weeks, earlier/later until the child is discharged from hospital 
Length of PICU stay  At 4 weeks, earlier/later until the child is discharged from PICU 
Length of hospital stay  At 4 weeks, earlier/later until the child is discharged from hospital 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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   Phase 3 
Date of First Enrollment (India)   31/03/2025 
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="7"
Days="10" 
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  

Ventilator-associated pneumonia (VAP) emerges as a hospital-acquired infection affecting the lower respiratory tract in individuals on mechanical ventilation, typically manifesting >or = 48 hours after ventilation initiation. Its correlation with prolonged ventilator reliance, extended stays in intensive care and hospitals, increased mortality rates, and substantial financial burdens is evident.

Infants and children on artificial airways necessitate endotracheal suctioning to clear secretions and avert airway blockages. Within pediatric intensive care units (PICUs), two primary suctioning systems are used commonly: open endotracheal suctioning (OES), which requires disconnection using single-use catheters, and closed-system suctioning (CSS), utilizing multiple-use in-line catheters that permit uninterrupted mechanical ventilation during suctioning. CSS proposes potential advantages including enhanced physiological stability and reduced infection risks by eliminating environmental contamination of the catheter before its introduction into the endotracheal tube and by limiting the dispersal of infectious mucus particles. Despite these suggestions, the recommendation of CSS as a preventive measure for pediatric VAP lacks substantial supporting evidence.

Despite meta-analyses and randomized controlled trials revealing no significant disparities between OES and CSS in VAP occurrence among adults and neonates, clear evidence in the pediatric age group is presently lacking.

 
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