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

NCT06054503 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2024-07-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Archeon

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-26
Primary Completion
2024-06-06
Completion
2024-06-06

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06054503 on ClinicalTrials.gov