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.

Not yet recruiting

• Conditions: Orotracheally intubated patients on the ventilator.

• Registration Number: CTRI/2018/04/013291
• Lead Sponsor: Coeo Labs private Limited

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-05-04
• Study Start: 2018-05-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 has pre-existing pneumonia at time of admission 10.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to demonstrate the performance of the device (VAPCare)	1. After 6 months | 2. After 1 year
The performance will be measured by the following endpoints:	1. After 6 months | 2. After 1 year
1. Volume of secretions collected	1. After 6 months | 2. After 1 year
2. Visual confirmation of lavage and suction cycles	1. After 6 months | 2. After 1 year
3. Visual confirmation of secretion clearance	1. After 6 months | 2. After 1 year

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Omni Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Omni Hospital

🇮🇳Hyderabad, ANDHRA PRADESH, India

Chintamani Nagaraj

Principal investigator

04067369999

nagaraj.chintamani@yahoo.com