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

July 15, 2024 updated by: Archeon

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Besançon, France, 25000
        • CHU de Besançon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: prototype of sensor
The patient is his own control
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
Active Comparator: ventilator
The patient is his own control
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
2 hours
Precision range of the insufflated volume between the sensor prototype and the one measured by the reference ventilator
Time Frame: 2 hours
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
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
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
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
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
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
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
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
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
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
2 hours
Number and frequency of device deficiencies
Time Frame: 2 hours 30 minutes
2 hours 30 minutes
Number and frequency of adverse events
Time Frame: 2 hours 30 minutes
2 hours 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Archeon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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