Status:
COMPLETED
Pilot Clinical Investigation to Evaluate a Prototype of Sensor Measuring Ventilator-derived Parameters
Lead Sponsor:
Archeon
Conditions:
Mechanically Ventilated Patients
Eligibility:
All Genders
18+ years
Phase:
NA
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 accel...
Eligibility Criteria
Inclusion
- Male or female patient aged 18 years or above
- 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
- Sedated patient with or without NBA (Neuromuscular Blocking Agent)
- Patient with a positive end-expiratory pressure (PEEP) ≤ 10 cm H2O
- Patient stable without recent (less than one hour) or planned intervention (such a bronchoscopy, prone positioning, physiotherapy)
- The primary attending physician approves use of the protocol on the patient
- Anticipated length of intubation \> 2 hours per patient
- 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
- Patient affiliated to the French social security regimen
- Procedure will be performed at least 30 minutes after inhaled treatment (eg salbutamol)
Exclusion
- 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%)
- 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)
- Patient with a significant lower airway obstruction (asthma…), confirmed by ventilator spirometry.
- Inability to maintain the airway intubation
- Patient with a recent history of cardiac and/or respiratory arrest
- Patient with multiple-organ system failure
- Patient with hemodynamic instability (tachycardia, rapid change of vasopressor)
- Pregnancy
- Participation in another clinical investigation at the same time as the present clinical investigation
- Nitric oxide use
Key Trial Info
Start Date :
September 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2024
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT06054503
Start Date
September 26 2023
End Date
June 6 2024
Last Update
July 16 2024
Active Locations (1)
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1
CHU de Besançon
Besançon, France, 25000