Safety and performance of the INBENTUS VERSATILE ventilator in adults on invasive mechanical ventilation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pre-market clinical trial of a non-CE-marked INBENTUS VERSATILE ventilator enrolling 81 adult participants. Participants will receive invasive mechanical ventilation in assisted/controlled modes for between 3 and 48 hours, followed by weaning under partial pressure support or volume support and monitoring until ICU discharge, hospital discharge, or 30 days. The study includes a Validation Cohort (up to 20 participants) for initial device validation and a Study Cohort (up to 61 participants) to confirm safety and performance. Primary endpoints are device- or procedure-related serious adverse events (safety) and the technical failure rate (performance).

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

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.

Where it's running

• Hospital Universitario Virgen de la Arrixaca
  Murcia, Spain Recruiting

Study contacts

• Study coordinator: Mar Gomez, Clinical Operations Manager
• Email: mar.gomez@inbentus.com
• Phone: +34 868965272

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.