Medical Device Clinical Trial Without CE Marking to Evidence Safety and Performance of the INBENTUS VERSATILE Ventilator in Patients Requiring Assisted/Controlled Mechanical Ventilation and Weaning.
Participants ≥ 18 years of age at the time of consent.
Participants requiring invasive mechanical ventilation for a period of ≥3 hours.
Participants must provide written informed consent.
You may not be if
1. Participants requiring anesthetic delivery systems or aerosol nebulizer systems.
2. Participants requiring modifications to the ventilator circuit, such as those treated with nitric oxide (iNO).
3. Any participant determined by the research team to be hemodynamically unstable, defined as:
1. MAP \< 65 mmHg despite vasoactive drugs.
2. Systolic Blood Pressure \> 180 mmHg.
3. Diastolic Blood Pressure \> 110 mmHg.
4. Severe volume loss (\>30% of blood volume) with persistent signs of hypoperfusion.
4. Life expectancy of less than 12 months.
5. Pregnant women at the time of informed consent.
Clareo Health | Medical Device Clinical Trial Without CE Marking to Evidence Safety and Performance of the INBENTUS VERSATILE Ventilator in Patients Requiring Assisted/Controlled Mechanical Ventilation and Weaning.
