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CTRI Number  CTRI/2018/04/013291 [Registered on: 16/04/2018] Trial Registered Prospectively
Last Modified On: 05/04/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   A clinical study for safety and efficacy of a device automatically remove saliva and other fluid and other secretions from the airway ans also does mouthwash for the intubated patients. 
Scientific Title of Study   Preliminary study to assess the performance of a device designed to perform automatic suctioning of oropharyngeal and subglottic secretions and perform automated oral lavage in orotracheally intubated ICU patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chinthamani Nagaraj 
Designation  HOD, Anaesthesia and Critical Care Department. 
Affiliation  Omni Hospitals 
Address  Department of Anesthesia,OT complex, 3rd floor,, Plot No.W-11,B-9, Sy. No.9/1/A, Near SVC Cinema Theatre, Opp. PVT Market, Kothapet, Dilsukhnagar, Hyderabad, Telangana

Hyderabad
ANDHRA PRADESH
500036
India 
Phone  9849009559  
Fax    
Email  nagaraj.chintamani@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Vimal Kishore Kakani 
Designation  Director-Clinical innovations 
Affiliation  Coeo Labs Private Limited 
Address  Department of design and development, room number 3, 5th floor,#4,aanand tower, raja ram mohan roy road, sampangirama nagara, Bangalore

Bangalore
KARNATAKA
560025
India 
Phone  8867378155  
Fax    
Email  vimal@coeo.in  
 
Details of Contact Person
Public Query  
Name  Vimal Kishore Kakani 
Designation  Director-Clinical innovations 
Affiliation  Coeo Labs Private Limited 
Address  Departmen of design and development, room number 3, 5th floor#4,aanand tower, raja ram mohan roy road, sampangirama nagara, Bangalore

Bangalore
KARNATAKA
560025
India 
Phone  8867378155  
Fax    
Email  vimal@coeo.in  
 
Source of Monetary or Material Support  
Coeo Labs Private Limited, #4, Northwing,Aanand Tower, Raja Ram Mohan Roy Road, Samapangi Rama Nagar, Bangalore -560025 
 
Primary Sponsor  
Name  Coeo Labs private Limited 
Address  #4, Aanand Tower,Rajaram Mohan Roy, Sampangi Rama Nagara, Bangalore, India-560025 
Type of Sponsor  Other [Medical Device Company India] 
 
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 
Chintamani Nagaraj  Omni Hospital  Department of Anesthesia and Critical Care, OT Complex, 3rd Floor,Plot No.W-11,B-9, Sy. No.9/1/A, Near SVC Cinema Theatre, Opp. PVT Market, Kothapet, Dilsukhnagar, Hyderabad, Telangana 500036
Hyderabad
ANDHRA PRADESH 		 04067369999

nagaraj.chintamani@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Divine Ethics Committee Omni Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Orotracheally intubated patients on the ventilator.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  secretion and oral hygiene management system  The patient population under the study will be on the a secretions and oral hygiene management system for the orotracheally intubated patients. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Patients requiring mechanical ventilation for 48 hrs or more
2. Patients must be between 18 - 75 years of age (Male or Female).
3. Patient must have been intubated with Portex (Smiths Medical) a CASS ET Tube.
4. A physician is able to place the suction lumen appropriately and fix it in position
5. Patient or a legal representative of the patient must be able to give written consent for the study. 
 
ExclusionCriteria 
Details  1. Patient intubated for more than 12 hours
2. Patient admitted for cardiac surgery/post cardiac surgery
3. Patient admitted with tracheostomy
4. Patient with bleeding disorders
5. Patient on oral anticoagulants
6. Patient with head, neck or facial injury
7. Patient is pregnant
8. Patient with/post cardiac arrest
9. Patient has pre-existing pneumonia at time of admission
10. Patient has COPD requiring life-long antibiotic therapy
11. Patient in post-lung transplant state 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary objective of the study is to demonstrate the performance of the device (VAPCare)
The performance will be measured by the following endpoints:
1. Volume of secretions collected
2. Visual confirmation of lavage and suction cycles
3. Visual confirmation of secretion clearance 		 1. After 6 months
2. After 1 year
 
 
Secondary Outcome  
Outcome  TimePoints 
To demonstrate the safety of the device (VAPCare).  After 6 Months of the study initiation. 
To record the final patient outcomes.  Dual: After 1 year of the study. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/05/2018 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not applicable. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Oral hygiene management, through suctioning secretions and anti-microbial mouth lavage, is a key procedure for intubated and ventilated patients- as it has been shown to be very effective in reducing the incidence of pneumonia (VAP) in such long-term intubated patients.
Currently, this procedure is performed manually by the ICU nurse, with highly variable effectiveness. This is because factors such as user training, workload, hand hygiene practices, among others can vary widely across institutions. Consequently, poor oral hygiene management is considered a key reason for the high rates of VAP seen in India.
VAPCare is a system that can provide a consistent and effective secretion removal and oral hygiene management to ventilated ICU patients. This study is needed to evaluate the safety and efficacy of this system in the real-world setting.
 
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