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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: INBENTUS VERSATILE Ventilation.
- Who it may be relevant to
- Registry conditions: Acute Respiratory Distress Syndrome (ARDS), Pneumonia, COPD (Chronic Obstructive Pulmonary Disease), Postoperative Respiratory Distress. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Pre-market clinical trial on 81 aldults participants to evidence safety and performance of the non-CE-marked medical device INBENTUS VERSATILE ventilator. The 81 aldult participants are ventilated between 3 and 48 hours with invasive mechanical ventilation (IMV) in assisted/controlled mode and weaning under partial pressure support or volume support, followed by monitoring period until ICU discharge, hospital discharge or 30 days. The study design differentiates between a Validation Cohort (up to 20 participants) for device validation and a Study Cohort (up to 61 participants) for safety and performance confirmation. Serious Adverse Events related to study device and/or its procedure is defined as the primary safety endpoint, whereas technical failure rate is defined as the primary performance endpoint.
Interventions
- Device INBENTUS VERSATILE Ventilation
INBENTUS VERSATILE ventilation according to protocol specifications and clinical needs
Primary outcome measures
- Primary Safety Endpoint [Time frame: From 3 to 48 hours of mechanical ventilation under the study device]
- Primary Performance Endpoint [Time frame: From 3 to 48 hours of mechanical ventilation under the study device]
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
- Participants requiring anesthetic delivery systems or aerosol nebulizer systems.
- Participants requiring modifications to the ventilator circuit, such as those treated with nitric oxide (iNO).
- Any participant determined by the research team to be hemodynamically unstable, defined as:
- MAP < 65 mmHg despite vasoactive drugs.
- Systolic Blood Pressure > 180 mmHg.
- Diastolic Blood Pressure > 110 mmHg.
- Severe volume loss (>30% of blood volume) with persistent signs of hypoperfusion.
- Life expectancy of less than 12 months.
- Pregnant women at the time of informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Spain · 1 center
- Hospital Universitario Virgen de la Arrixaca — Murcia
Identifiers
NCT: NCT07432191 · IMIB-VTL-2023-01