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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013291
Enrollment
50
Registered
2018-04-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Orotracheally intubated patients on the ventilator.

Interventions

Intervention1: 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 pat

Sponsors

Coeo Labs private Limited
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 clearanceTimepoint: 1. After 6 months 2. After 1 year—

Secondary

MeasureTime frame
To demonstrate the safety of the device (VAPCare).Timepoint: After 6 Months of the study initiation.;To record the final patient outcomes.Timepoint: Dual: After 1 year of the study.—

Countries

India

Contacts

Public ContactVimal Kishore Kakani

Coeo Labs Private Limited

vimal@coeo.in8867378155

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026