COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57195

Dr Vimal Bhardwaj

vimal.bhardwaj.dr@narayanahealth.org

2021-08-05

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

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 <br/ >2.the patient/ legally authorized representative/ patient relative, provide written informed consent to participate in the study. <br/ >3.Patient should be confirmed having COVID 19 infection by RTPCR/Antigen/CT Scan or any other approved method <br/ >4.The patient is intubated within 24 Hours of vapcare device initiation <br/ >

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

2

Dr Vimal Bhardwaj

18

99

India

Critical disease at enrollment

8: Critical disease at enrollment

100

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

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 1889, "treatment_name": "Vapcare", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]