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

All India Institute of Medical Sciences Jodhpur0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年2月6日

试验速览

暂无简介。

•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.

•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
•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.

发起方

All India Institute of Medical Sciences Jodhpur