To test a device which can split the air flow coming from one ventilator into two air columns through which two patients can be benefitted simulateously without harming the original ventilator or the patients.

Phase 1

• Conditions: Health Condition 1: J22- Unspecified acute lower respiratory infection

• Registration Number: CTRI/2023/01/049042
• Lead Sponsor: All India Institute of Medical Sciences Jodhpur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

a.Provision of signed and dated informed consent form by patient or healthcare proxy.

b.At least one RT-PCR assay for SARS-CoV2 with negative result in the last 7 days.

c.Currently requiring stable mechanical ventilation with no plan to extubate or change ventilation settings for the next 48 hours.

d.Greater than or equal to 18 years of age.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

a.Suspected or laboratory-confirmed SARS-CoV-2.

b.Patients deemed unsafe to transition ventilators.

c.Severe hypoxemia requiring mechanical ventilation with FiO2 > 80%, PEEP > 15 cmH2O or prone positioning.

d.Severe cardiac valvular disease

e.Severe pulmonary hypertension or right heart failure

f.Receiving intravenous: epoprostenol, milrinone, dobutamine, dopamine or epinephrine

g.Receiving high intravenous infusions of norepinephrine ( >20 mcg/min), vasopressin ( >0.04 u/min) or phenylephrine ( >150 mcg/min)

h.Receiving inhaled: epoprostenol or nitric oxide

i.Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, extracorporeal membrane oxygenation)

j.Congenital heart disease

k.Known or suspected elevated intracranial pressure

l.Pregnant

m.Patients currently (or within 30 days) participating in clinical trial with investigational drug or device

n.Any other medical condition, which in the opinion of the investigator, would place the patient at undue risk from participating.

Study & Design

• Study Type: Interventional
• Study Design: Not specified