Mechanically Ventilated PatientsNCT06054503
Pilot Clinical Investigation to Evaluate a Prototype of Sensor Measuring Ventilator-derived Parameters
A study testing prototype of sensor in people with Mechanically Ventilated Patients, run by Archeon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanically Ventilated Patients
- What is being tested?
- prototype of sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2023to 6 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- prototype of sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prototype of sensorDevice
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
| Study group | Role | What they receive |
|---|---|---|
| prototype of sensor | Experimental | The patient is his own control Receives: Device: prototype of sensor |
| ventilator | Active comparator | The patient is his own control Receives: Device: prototype of sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of patients for whom the insufflated volume measured by the sensor prototype is equivalent to the one measured by the ventilatory monito
Measured: 2 hours
Secondary outcomes (16)
Number and proportion of patients for whom the exhaled volume measured by the sensor prototype are equivalent to the one measured by the ventilatory monitor
Measured: 2 hours
Number and proportion of patients for whom the pressure measured by the sensor prototype are equivalent to the one measured by the ventilatory monitor
Measured: 2 hours
Number and proportion of patients for whom the flow rate measured by the sensor prototype are equivalent to the one measured by the ventilatory monitor
Measured: 2 hours
Precision range of the insufflated volume between the sensor prototype and the one measured by the reference ventilator
Measured: 2 hours
Number and proportion of patients for whom the leak percentage calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Measured: 2 hours
Number and proportion of patients for whom the insiratory time calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Measured: 2 hours
Number and proportion of patients for whom the expiratory time calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Measured: 2 hours
Number and proportion of patients for whom the pause time calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Measured: 2 hours
Number and proportion of patients for whom the plateau time calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Measured: 2 hours
Number and proportion of patients for whom the respiratory rate calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Measured: 2 hours
Number and proportion of patients for whom the mechanical power calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Measured: 2 hours
Number and proportion of patients for whom the lung resistance calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Measured: 2 hours
Number and proportion of patients for whom the lung compliance calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Measured: 2 hours
Number and proportion of patients for whom the lung elastance calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Measured: 2 hours
Number and frequency of device deficiencies
Measured: 2 hours 30 minutes
Number and frequency of adverse events
Measured: 2 hours 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start26 Sep 2023
- Primary completion6 Jun 2024
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanically Ventilated PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The patient is his own control
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Archeon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054503
- Sponsor's protocol ID
- H03
- Status last verified
- Sep 2023
- First submitted
- 12 Jul 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06054503
- Acronym / sponsor ID
- H03
- Conditions
- Mechanically Ventilated Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- ArcheonIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patient is his own control
| Arm | Type | Receives |
|---|---|---|
| prototype of sensor | Experimental | Device: prototype of sensorThe patient is his own control |
| ventilator | Active comparator | Device: prototype of sensorThe patient is his own control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prototype of sensorThe 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 | Device | prototype of sensor, ventilator |
Primary outcome
Number and proportion of patients for whom the insufflated volume measured by the sensor prototype is equivalent to the one measured by the ventilatory monito
Time frame: 2 hours
16 secondary outcomes
Number and proportion of patients for whom the exhaled volume measured by the sensor prototype are equivalent to the one measured by the ventilatory monitor
Time frame: 2 hours
Number and proportion of patients for whom the pressure measured by the sensor prototype are equivalent to the one measured by the ventilatory monitor
Time frame: 2 hours
Number and proportion of patients for whom the flow rate measured by the sensor prototype are equivalent to the one measured by the ventilatory monitor
Time frame: 2 hours
Precision range of the insufflated volume between the sensor prototype and the one measured by the reference ventilator
Time frame: 2 hours
Number and proportion of patients for whom the leak percentage calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Time frame: 2 hours
Number and proportion of patients for whom the insiratory time calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Time frame: 2 hours
Number and proportion of patients for whom the expiratory time calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Time frame: 2 hours
Number and proportion of patients for whom the pause time calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Time frame: 2 hours
Number and proportion of patients for whom the plateau time calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Time frame: 2 hours
Number and proportion of patients for whom the respiratory rate calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Time frame: 2 hours
Number and proportion of patients for whom the mechanical power calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Time frame: 2 hours
Number and proportion of patients for whom the lung resistance calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Time frame: 2 hours
Number and proportion of patients for whom the lung compliance calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Time frame: 2 hours
Number and proportion of patients for whom the lung elastance calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator
Time frame: 2 hours
Number and frequency of device deficiencies
Time frame: 2 hours 30 minutes
Number and frequency of adverse events
Time frame: 2 hours 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prototype of sensor in people with Mechanically Ventilated Patients, run by Archeon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and proportion of patients for whom the insufflated volume measured by the sensor prototype is equivalent to the one measured by the ventilatory monito (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.