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CTRI Number  CTRI/2026/01/100470 [Registered on: 07/01/2026] Trial Registered Prospectively
Last Modified On: 30/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Ph.D thesis]  
Study Design  Other 
Public Title of Study   Preventing Ventilator-Associated Pneumonia in Intensive Care Patients 
Scientific Title of Study   A prospective study to evaluate the effectiveness of ventilator bundle technique in the prevention of ventilator associated Pneumonia among patients on ventilator in intensive care unit in Kanyakumari Govt Medical College Hospital Asaripallam 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Paramasivam Asari Geetha 
Designation  Phd Scholar 
Affiliation  Kanyakumari govt Medical college 
Address  Kanyakumari govt Medical college Asaripallam Department of Nursing School of Nursing Nursing Tutor 1st floor Room No 12

Kanniyakumari
TAMIL NADU
629201
India 
Phone  9442856687  
Fax    
Email  geethaparamasivam1975@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. V.R. Mohan Rao 
Designation  Professor and HOD 
Affiliation  Chettinad Hospital and Research Institute 
Address  Chetinad Academy of Research and Education. Department of General Medicine, 2nd floor Room No. 205 Chettinad Hospital and Research Institute Chennai

Chennai
TAMIL NADU
603103
India 
Phone  9841210011  
Fax    
Email  vrmohan_rao@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Paramasivam Asari Geetha 
Designation  Tutor  
Affiliation  Kanyakumari govt Medical college 
Address  Department of Nursing, school of nursing, 1st floor, room No 12 kanyakumari govt medical college kanyakumari district
Department of Nursing, school of nursing, 1st floor, room No 12 kanyakumari govt medical college kanyakumari district
Kanniyakumari
TAMIL NADU
629201
India 
Phone  9442856687  
Fax    
Email  geethaparamasivam1975@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Paramasivam Asari Geetha 
Address  Department of Nursing, school of nursing, 1st floor, room No 12 kanyakumari govt medical college kanyakumari district  
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 
DrV R Mohan Rao  Kanyakumari govt Medical College Hospital  Department-General Medicine and General Surgery, Division-Adult Critical Care Unit. Room Number: main building 1st floor.
Kanniyakumari
TAMIL NADU 		 9841210011
-
vrmohan_rao@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC KANYAKUMARI GOVT MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: J13||Pneumonia due to Streptococcus pneumoniae,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ventilator Bundle Technique  Patients allocated to the experimental group will receive the ventilator bundle technique in addition to routine ICU care. The ventilator bundle will be implemented by trained nursing personnel and comprises evidence-based practices aimed at preventing ventilator-associated pneumonia. These include maintaining the head end of the bed elevated at 30–45 degrees, conducting daily assessments for readiness to wean from mechanical ventilation, providing regular oral care as per ICU protocol, ensuring strict hand hygiene and aseptic techniques during endotracheal suctioning, maintaining appropriate endotracheal tube cuff pressure, and adopting measures to prevent aspiration during suctioning and routine nursing care. The ventilator bundle intervention will be administered for three consecutive days following patient enrollment. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients who receive mechanical ventilation.
Both male and female patients
 
 
ExclusionCriteria 
Details  Patients after 24 hours of intubation.
Patients already diagnosed with fever, pneumonia and acute respiratory distress syndrome.
Patients with cervical and spinal cord injury.
Patients already intubated from outside hospital
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Incidence and severity of ventilator-associated pulmonary infection  4th day of mechanical ventilation 
 
Secondary Outcome  
Outcome  TimePoints 
pulse rate
respiratory rate
SPo2
auscultation findings of lung fireld
Presence of respiratory discomfort
duration of intubation 		 4th day of mechanical ventilation 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/12/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  mail request to primary author

  6. For how long will this data be available start date provided 01-07-2025 and end date provided 31-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

            

The tool consists  of  Two  sections

Section A

 It consists of 6 number of items of socio demographic variables of age, sex, occupation, area of residence, history of smoking, and duration of admission in hospital.

 Section B 

Clinical variables consists of diagnosis, duration of intubation, size of the endotracheal tube, medication and history of previous hospitalization, pulse, Respiration, Spo2, Auscultation of lung fields, Presence of discomfort.

 
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