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CTRI Number  CTRI/2025/12/099492 [Registered on: 19/12/2025] Trial Registered Prospectively
Last Modified On: 18/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluating economically and clinically whether an automatic suction device can safely help prevent ventilator-associated pneumonia (VAP) in patients on ventilators in the neuro ICU: a randomized controlled study.” 
Scientific Title of Study   Economic and Clinical Impact of Automated Suction device on VAP prevention in Mechanically Ventilated Neurocritical Care Patients. A Randomized Controlled Non-Inferiority 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  Manisha J 
Designation  Senior Resident 
Affiliation  NIMHANS 
Address  Department of Neuroanesthesia and Neurocritical care, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur road

Bangalore
KARNATAKA
560029
India 
Phone  9740192886  
Fax    
Email  manishajs411@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dhritiman Chakrabarti 
Designation  Associate Professor 
Affiliation  NIMHANS 
Address  Department of Neuroanesthesia and Neurocritical care, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur road

Bangalore
KARNATAKA
560029
India 
Phone  8197781240  
Fax    
Email  dhritiman.ch@gmail.com  
 
Details of Contact Person
Public Query  
Name  Manisha J 
Designation  Senior Resident 
Affiliation  NIMHANS 
Address  Department of Neuroanesthesia and Neurocritical care, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur road

Bangalore
KARNATAKA
560029
India 
Phone  9740192886  
Fax    
Email  manishajs411@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  NIMHANS 
Address  Department of Neuroanesthesia and Neurocritical care, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur road 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
INNACCEL Technologies Pvt Ltd  5th Floor Aanad Towers, Raja Rammohan Roy Road, near Richmond Circle, Sampangiramanagar, Bangalore - 560025 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manisha J  National Institute of Mental Health and Neuro Sciences  Neurocritical care ICU, Emergency ICU, Subspecialty Block ICU, Department of Neuroanaesthesia and Neurocritical care, Hosur road, Bangalore -560029
Bangalore
KARNATAKA 		 9740192886

manishajs411@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUITIONAL ETHICS COMMITTEE NIMHANS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, (2) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Manual Suctioning  All patients will be intubated with a Portex (Smiths Medical) above-the-cuff suction-enabled endotracheal tube with an integrated subglottic secretion drainage port. Standard VAP prevention measures will be followed, including head-end elevation to 30–45°, endotracheal suctioning as per ICU protocol, and daily oral care. Ventilator circuits will be changed once every six days. Patients will receive enteral nutrition, prophylactic proton pump inhibitors for stress-ulcer prevention, and appropriate deep vein thrombosis prophylaxis. Sedation, analgesia, and ventilator weaning will be managed according to current institutional protocols. Patients will be considered part of the study throughout their entire ICU stay or until ICU discharge, death, or withdrawal from the study, whichever occurs first. 
Intervention  Automated oropharyngeal and subglottic suction device (AOPS)  The intervention consists of using an Automated Subglottic Suction Device attached to the endotracheal tube to deliver intermittent subglottic suctioning. The device automatically clears secretions accumulating above the endotracheal cuff, reducing microaspiration, and is initiated immediately after patient enrollment and maintained for the entire duration of mechanical ventilation. The system operates with a subglottic suction pressure of 45 mmHg, an oropharyngeal suction pressure of 110 mmHg, and a programmed suctioning interval of every 30 minutes. Standard ventilatory care bundles are applied in both groups, with the automated suction mechanism being the only difference in the intervention arm. Patients will be considered part of the study throughout their entire ICU stay or until ICU discharge, death, or withdrawal from the study, whichever occurs first. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients admitted to Neuro critical care ICU requiring mechanical ventilation 
 
ExclusionCriteria 
Details  Patients with tracheostomy, latex allergy, oropharyngeal bleeding or bleeding disorders, faciomaxillary or cervical spine injuries
Patients admitted with primary lung pathology.
Severe immune dysfunction
Non provision of consent for participation in the study by self or relatives.
Vulnerable populations such as patients with mental illness, physical disabilities, elderly individuals, pregnant or lactating women, patients with chronic neurological disorders and terminally ill patients will be excluded from study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the average per day total direct costs of ICU stay between automated and manual suction strategies.  Patients will be included at baseline (Day 0), defined as ICU admission following surgery or intervention. Outcome and clinical variables will be assessed once daily (Day 1 onwards) throughout the ICU stay. Final assessment will occur at ICU discharge, death, or study withdrawal, whichever occurs first. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the economic burden of equipment,consumable, drugs,investigations,human resource utilization between the two groups during ICU stay, under the following headers:
1.Medications
2.Diagnostic Investigations (Cultures, Imaging)
3.Intervention charges (Surgical, Radiology)
4.Consumables (RT, ET tube, foleys, arterial line, IV cannula, central line, Suction bottle, Tubing’s, AOPS consumables)
5.ICU Stay,ICU bed, Ventilator, AOPS device, Monitoring (Multiparameter monitor, EEG, TCD, arterial, ICP, Ultrasound)
6.ICU Stay & Admission charges
7.Human resources (Doctor, Nursing, Physiotherapy, Dietician etc) 		 Patients will be included at baseline (Day 0), defined as ICU admission following surgery or intervention. Outcome & clinical variables will be assessed once daily (Day 1 onwards) throughout the ICU stay. Final assessment will occur at ICU discharge, death, or study withdrawal, whichever occurs first. 
To compare the duration of mechanical ventilation between AOPS & standard care groups  Patients will be included at baseline (Day 0), defined as ICU admission following surgery or intervention. Outcome & clinical variables will be assessed once daily (Day 1 onwards) throughout the ICU stay. Final assessment will occur at ICU discharge, death, or study withdrawal, whichever occurs first. 
To quantify antibiotic consumption in patients managed between automated & manual suction strategies.  Patients will be included at baseline (Day 0), defined as ICU admission following surgery or intervention. Outcome & clinical variables will be assessed once daily (Day 1 onwards) throughout the ICU stay. Final assessment will occur at ICU discharge, death, or study withdrawal, whichever occurs first. 
To evaluate the impact on the need for reserve antibiotics & escalation/de-escalation patterns between two groups.  Patients will be included at baseline (Day 0), defined as ICU admission following surgery or intervention. Outcome & clinical variables will be assessed once daily (Day 1 onwards) throughout the ICU stay. Final assessment will occur at ICU discharge, death, or study withdrawal, whichever occurs first.
 
To compare length of ICU stay between AOPS & standard care groups  Patients will be included at baseline (Day 0), defined as ICU admission following surgery or intervention. Outcome & clinical variables will be assessed once daily (Day 1 onwards) throughout the ICU stay. Final assessment will occur at ICU discharge, death, or study withdrawal, whichever occurs first. 
To compare the frequency of Investigations (including cultures) between AOPS & standard care groups.  Patients will be included at baseline (Day 0), defined as ICU admission following surgery or intervention. Outcome & clinical variables will be assessed once daily (Day 1 onwards) throughout the ICU stay. Final assessment will occur at ICU discharge, death, or study withdrawal, whichever occurs first. 
To determine safety variables: Tissue injury (abrasion or laceration)  Patients will be included at baseline (Day 0), defined as ICU admission following surgery or intervention. Outcome & clinical variables will be assessed once daily (Day 1 onwards) throughout the ICU stay. Final assessment will occur at ICU discharge, death, or study withdrawal, whichever occurs first. 
To compare the patient-borne indirect costs—specifically lost wages/salary of the patient during hospitalization.  Patients will be included at baseline (Day 0), defined as ICU admission following surgery or intervention. Outcome & clinical variables will be assessed once daily (Day 1 onwards) throughout the ICU stay. Final assessment will occur at ICU discharge, death, or study withdrawal, whichever occurs first. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   30/12/2025 
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="0"
Months="10"
Days="0" 
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 is a common and preventable hospital acquired infection among mechanically ventilated patients and leads to prolonged ICU stay increased antibiotic use and higher healthcare costs. Neurocritical care patients are at particularly high risk because they require longer ventilation and intensive monitoring resulting in a greater economic burden. Although standard ventilator associated pneumonia prevention bundles are effective adherence is variable and manual suctioning increases nursing workload. Automated airway management systems such as Automated Oropharyngeal and Subglottic Suction AOPS may improve secretion clearance reduce ventilator associated pneumonia incidence shorten ventilation duration lessen antibiotic requirements and lower ICU costs. However evidence on their economic impact in neurocritical care is limited.

This single centre open label prospective randomized non inferiority study will be conducted in the ICU at NIMHANS Bangalore. Adult neurointerventional and neurosurgical patients requiring mechanical ventilation will be randomized to automated suctioning or conventional manual suctioning. All patients will receive standard ventilator associated pneumonia prevention measures. The study will compare average per day direct ICU costs as the primary outcome. Secondary outcomes include costs of medications diagnostics consumables equipment human resource utilization duration of ventilation antibiotic use escalation patterns ICU stay investigation frequency and safety outcomes. Indirect patient costs such as loss of wages will also be assessed.

 
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