CTRI/2023/01/049042
Not Yet Recruiting
Phase 1
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 sites0 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- All India Institute of Medical Sciences Jodhpur
- Status
- Not Yet Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not Yet Recruiting
N/A
Assessment of safety, accuracy and ease of use of the Tournicare blood pressure (BP) monitor compared with a clinically validated BP monitor based on multiple measurements on up to 30 participants.Blood PressureACTRN12618001028291Tournicare Pty Ltd30
Completed
N/A
Pilot study into the validity and usability of the DynMetrics gait analysis system.Stroke10007963NL-OMON46512Revalidatiecentrum Het Roessingh15
Recruiting
Phase 1
A study to evaluate safety and feasibility of zoledronic acid to prevent joint complication (osteonecrosis) following chemotherapy for acute lymphoblastic leukemia or lymphoma in children and adolescents.Acute lymphoblastic leukemiaLymphoblastic lymphomaOsteonecrosisCancer - Leukaemia - Acute leukaemiaCancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphomaMusculoskeletal - Other muscular and skeletal disordersACTRN12613000512729Sydney Children's Hospital Network10
Active, Not Recruiting
Phase 1
Pilot study to evaluate the efficacy and safety of mefloquine as prophylaxis in people exposed to the disease caused by the new SARS-CoV-2 coronavirus (COVID-19)COVID-19 infection is being spread around the world with more than 400.000 cases. The spred of the disease is being a world health problem.Therapeutic area: Diseases [C] - Virus Diseases [C02]EUCTR2020-001194-69-ESFélix Gutiérrez Rodero200
Recruiting
N/A
Pilot study to evaluate the efficacy and safety of MegaNuovo in Pressure sore patients : single center, comparative, investigator-initiated pilot studyDiseases of the skin and subcutaneous tissueKCT0006745Yonsei University, Wonju Severance Christian Hospital30