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.

Pilot study to evaluate safety and usability of the Individualized System for Augmenting Ventilator Efficacy (iSAVE) ventilator splitter in mechanically ventilated patients - iSAVE

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/049042

Enrollment

Registered

2023-01-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: J22- Unspecified acute lower respiratory infection

Interventions

Intervention1: iSAVE: a ventilator splitter device.: It is a ventilator splitter device which splits the air supplied by a ventilator into two parts which can be given to two patients simultaneously.

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1) Improvement in Oxygenation status in terms of P/F ratio after 12 hours of iSAVE (splitter device) use. 2) Blood carbondioxide value as detected by arterial blood gas sampling while the patient is on iSAVE (splitter device).Timepoint: 12 hours	—

Secondary

Measure	Time frame
1) Effect of suctioning of one patient on the other patient connected through iSAVE device. 2) Effect of coughing of one patient on the flow distribution on the other patient.Timepoint: 0 hour, 2 hour, 4 hour, 6 hour, 8 hour, 10 hours and 12 hours.	—

Countries

India

Contacts

Public ContactNikhil Kothari

All India Institue of Medical Sciences (AIIMS), Jodhpur

drnikhilkothari@gmail.com8003996948

Outcome results

None listed

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