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

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.

This trial will test whether the INBENTUS VERSATILE ventilator is safe and performs well in adults who need assisted or controlled invasive mechanical ventilation and short-term weaning.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 81 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Iconic Solutions By Murcia SL (Industry-sponsored)
• Locations: 1 site (Murcia)
• Trial ID: NCT07432191 on ClinicalTrials.gov

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).

Who should consider this trial

Good fit: Adults aged 18 or older who require invasive mechanical ventilation for at least 3 hours in assisted or controlled modes and who can provide informed consent, and who are hemodynamically stable, are appropriate candidates.

Not a fit: Patients who require anesthetic delivery systems, aerosol nebulizers, inhaled nitric oxide, are hemodynamically unstable, pregnant, or have life expectancy under 12 months are excluded and unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the device could provide a safe, effective ventilator option for short-term invasive ventilation and weaning, expanding available ICU equipment choices.

How similar studies have performed: Pre-market safety and performance trials of other mechanical ventilators are common and have generally shown feasibility, but clinical data specific to the INBENTUS VERSATILE are novel.

Eligibility criteria

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 this trial is running

Murcia

• Hospital Universitario Virgen de la Arrixaca — Murcia, Spain (Recruiting)

Study contacts

• Study coordinator: Mar Gomez, Clinical Operations Manager

Conditions Acute Respiratory Distress Syndrome; Pneumonia; COPD; Postoperative Respiratory Distress; Hypoventilation Syndrome; Hypoxemia; Hypercapnia