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

NCT ID: NCT06054503

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-26
• Study Completion Date: 2024-06-06

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

prototype of sensor

The patient is his own control

Group Type: EXPERIMENTAL

prototype of sensor

Intervention Type: DEVICE

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

ventilator

The patient is his own control

Group Type: ACTIVE_COMPARATOR

prototype of sensor

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female patient aged 18 years or above

2. Patient ventilated with the reference ventilators: Servo U - Maquet Critical Care AB, Röntgenvägen 2, 171 54 Solna, Sweden for intensive care unit or Perseus - Drägerwerk AG & Co. KGaA, Moislinger Allee 53-55, 23542 Lübeck, Germany for operating room

3. Sedated patient with or without NBA (Neuromuscular Blocking Agent)

4. Patient with a positive end-expiratory pressure (PEEP) ≤ 10 cm H2O

5. Patient stable without recent (less than one hour) or planned intervention (such a bronchoscopy, prone positioning, physiotherapy)

6. The primary attending physician approves use of the protocol on the patient

7. Anticipated length of intubation > 2 hours per patient

8. The patient or legally authorized representative has signed and dated a written Informed Consent Form (ICF) prior to the initiation of any clinical investigation procedures

9. Patient affiliated to the French social security regimen

10. Procedure will be performed at least 30 minutes after inhaled treatment (eg salbutamol)

Exclusion Criteria

1. Patient with a serious disease, for which the ventilation unplugging during a few seconds could have a serious impact (particularly patients with PaO2/Fi02 < 150 with pH < 7,30, with PEEP > 10 cm H20, or with Fi02 > 50%)

2. Patient with disease judged by the investigator to be incompatible with the conduct of the clinical investigation procedures or the interpretation of the clinical investigation results (example: IG-bronchopleural fistula)

3. Patient with a significant lower airway obstruction (asthma…), confirmed by ventilator spirometry.

4. Inability to maintain the airway intubation

5. Patient with a recent history of cardiac and/or respiratory arrest

6. Patient with multiple-organ system failure

7. Patient with hemodynamic instability (tachycardia, rapid change of vasopressor)

8. Pregnancy

9. Participation in another clinical investigation at the same time as the present clinical investigation

10. Nitric oxide use

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Archeon

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Besançon

Besançon, , France

Countries

France

Other Identifiers

H03

Identifier Type: -

Identifier Source: org_study_id