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Effect of VAPcare device in prevention of ventilator associated events in patients on ventilator

Efficacy and safety of automated antiseptic lavage and suctioning of oral, oro-pharyngeal and subglottic secretions (VAPCare) among ventilated patients with COVID 19 in developing ventilator associated events during hospitalization- a prospective randomised open blind end point study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035429
Enrollment
100
Registered
2021-08-05
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: B97- Viral agents as the cause of diseases classified elsewhere

Interventions

Intervention1: Intervention group: VAPCare medical device with a disposable lumen (VAPLumen) that rides over the ET tube with ports in the oral and oropharyngeal area for suctioning secretions. Oral,

Sponsors

Dr Vimal Bhardwaj
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.all the patients aged more than or equal to 18 years, both genders in the emergency and medical/ surgical intensive care units who require artificial ventilation for more than 48 hours 2.the patient/ legally authorized representative/ patient relative, provide written informed consent to participate in the study. 3.Patient should be confirmed having COVID 19 infection by RTPCR/Antigen/CT Scan or any other approved method 4.The patient is intubated within 24 Hours of vapcare device initiation

Exclusion criteria

Exclusion criteria: 1.A regular ET tube other than ETT above the cuff suction enabled endotracheal tube 2.A previous diagnosis of a.Pulmonary tuberculosis b.HIV c.Ventricular fibrillation d.Cardiac arrest e.Bleeding disorders f.Pregnancy g.Severe Head/ neck/ facial injuries 3.Tracheostomy at the time of admission 4.Patients enrolled for another clinical study

Design outcomes

Primary

MeasureTime frame
1.Incidence of VAE from date of intubation till 2 days post extubation/tracheostomyTimepoint: From intubation till 2 days post extubation

Secondary

MeasureTime frame
Antibiotic usageTimepoint: From intubation till 2 days post extubation;Duration of mechanical ventilationTimepoint: From intubation till 2 days post extubation;Mortality Timepoint: From intubation till 2 days post extubation;Volume of secretions collectedTimepoint: From intubation till 2 days post extubation

Countries

India

Contacts

Public ContactDr Vimal Bhardwaj

Mazumdar Shaw Medical Center, Narayana Health city

vimal.bhardwaj.dr@narayanahealth.org9686124830

Outcome results

None listed

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