NCT06054503

Pilot Clinical Investigation to Evaluate a Prototype of Sensor Measuring Ventilator-derived Parameters

A French Monocenter, Interventional Pilot Clinical Investigation to Evaluate the Technical Performance and Safety of a Prototype of Sensor to Measure Ventilator-derived Parameters in Intubated and Mechanically Ventilated Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Archeon · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Recently, the threat of viral pandemics (Covid-19, severe acute respiratory syndrome, avian flu H5N1, and H1N1), which might result in thousands of patients requiring mechanical ventilation, has accelerated the need for mechanical ventilation equipment. Disaster may create thousands of critically ill patients requiring mechanical ventilation and may force difficult allocation decisions when demand greatly exceeds supply. Creating a new monitor will only add one more product to the one already used and create confusion for the user. Therefore, the aim is now to develop an independent ventilation module, compatible with the already existing cardiac monitors, which integrates advanced ventilation monitoring functions (mechanical ventilation and RCP). This module could be used by the teams already equipped with multiparametric monitors and be a real added value as the monitoring of the ventilation is critical, especially in emergency situations. Then, it could answer to the clinical need and massively equip every hospital care center in the event of mass casualty incident or viral pandemic. Moreover, this device could be used by emergency teams during daily operations. The aim of this study is to validate a prototype of sensor intended to monitor ventilator parameters of ventilated patients and guide healthcare professionals to provide safe ventilation.

Conditions

• Mechanically Ventilated Patients

Interventions

Type	Name	Description
DEVICE	prototype of sensor	The investigational device is composed of a sensor placed on the respiratory line of the ventilated patients and connected to a ventilation measure unit which records the ventilation parameters

Timeline

• Start date: 2023-09-26
• Primary completion: 2024-06-06
• Completion: 2024-06-06
• First posted: 2023-09-26
• Last updated: 2024-07-16

Locations

1 site across 1 country: France