| 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.
|
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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.
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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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 |
|
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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.
|