Medical DeviceSMART-METRONCT04668807
Technical Capabilities of the "SMART ANGEL Intra-hospital" System 's Connected Medical Device (CMD)
A study testing Connected Medical Device and Traditional transmission system in people with Medical Device, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Post-operative mortality in case of scheduled surgery is 3% in France (Lancet 2013) mainly due to cardiovascular or respiratory complications, by decompensation of pre-existing pathologies. Complications due to the medical practice are the third cause of morbidity(BMJ, 2016). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Device
- What is being tested?
- Connected Medical Device and Traditional transmission system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2020to Jun 2021
- 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
- Age ≥ 18 years
- Patients receiving a non-ambulatory surgical or interventional procedure lasting more than 2 hours
- Affiliation with a social security syste, beneficiarie or eligible people (excluding State Medical Assistance (AME))
- Written consent of the patient
Who cannot join
- Patient carrying a multi-resistant germ and placed in isolation
- Patient's known linguistic inability to understand the study
- Non-ambulatory surgical or interventional act in an emergency situation
- Patients under legal protection : curatorship or guardianship
- Known pregnancy or nursing woman
- Patients with implantable cardiac pacemakers, implantable defibrillators or neurostimulators
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
Créteil, 94 010
Jean-Louis MARTY, MD, PhD, 01 49 81 43 45 ext. + 33, jean.marty@aphp.fr
About this study
Official title: Assessment of the Technical Capabilities of the "SMART ANGEL" Intra-hospital System 's Connected Medical Device (CMD)
Post-operative mortality in case of scheduled surgery is 3% in France (Lancet 2013) mainly due to cardiovascular or respiratory complications, by decompensation of pre-existing pathologies.
Complications due to the medical practice are the third cause of morbidity(BMJ, 2016). More than half are preventable and are mainly observed in surgical patients. In conventional hospitalization, excluding intensive care, monitoring is done discontinuously for most of the patients, which does not allow early diagnosis of a vital cardiovascular or respiratory failure.
Diagnosis and late treatment do not allow good recovery. The early identification of a vital failure by the continuous monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) would allow faster management by the hospital staff and a reduction in immediate and possibly delayed postoperative mortality.
Read the detailed description
The challenge of this research is to transpose in an ordinary hospitalization unit the continuous monitoring of vital functions carried out in intensive care by the continuous measurement of simple parameters using a Connected Medical Device (CMD).
- Conditions
- Medical Device
- Being tested
- Connected Medical Device, Traditional transmission system
- Keywords
- Connected Medical Device, Device Feasibility, Post-operative mortality, "SMART ANGEL intra-hospital" system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connected Medical DeviceDevice
Monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) with a Connected Medical Device (DMC) in the operating room
Traditional transmission systemDevice
Monitoring of physiological parameters with a traditional wired transmission system between the sensor and the data processing device in the operating room
| Study group | Role | What they receive |
|---|---|---|
| Connected Medical Device | Experimental | "SMART ANGEL Intra-hospital" System 's Connected Medical Device (DMC) measuring physiological parameters in the operating room Receives: Device: Connected Medical Device |
| Traditional system | Active comparator | Traditional wired transmission system between the sensor and the data processing device in the operating room Receives: Device: Traditional transmission system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between the values measurements produced by the traditional monitoring system in the operating theater and the connected medical device of the "SMART ANGEL intra-hospital" system
Measured: at 2 hours
Secondary outcomes (4)
Evaluation of missing data due to device malfunction
Measured: at 2 hours
Nurse satisfaction (System Usability Scale)
Measured: at 2 hours
Occurrence of events during the course of the study
Measured: at 2 hours
Time needed by the nursing staff to set up the system
Measured: at 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study startDec 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical DeviceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Measurement of 3 constants (SpO2, heart rate and respiratory rate) in patients with a non-ambulatory surgical or interventional act lasting more than 2 hours whose constants are monitored by the reference device in the operating room and the Connected Medical Device.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Evolucare Technologies, InES - Innovation Electronic Software
- Responsible party
- Sponsor
- Investigators
- Jean-Louis MARTY, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668807
- Sponsor's protocol ID
- APHP190708
- Other IDs
- 2019-A02197-50
- Acronym
- SMART-METRO
- Status last verified
- Feb 2020
- First submitted
- 5 Nov 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Technical Capabilities of the "SMART ANGEL" Intra-hospital System 's Connected Medical Device (CMD)
- ClinicalTrials.gov ID
- NCT04668807
- Acronym / sponsor ID
- SMART-METRO / APHP190708
- Conditions
- Medical Device
- Keywords
- Connected Medical Device, Device Feasibility, Post-operative mortality, "SMART ANGEL intra-hospital" system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Evolucare Technologies, InES - Innovation Electronic Software
- Study start
- Dec 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 16 Dec 2020 (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.
Post-operative mortality in case of scheduled surgery is 3% in France (Lancet 2013) mainly due to cardiovascular or respiratory complications, by decompensation of pre-existing pathologies.
Complications due to the medical practice are the third cause of morbidity(BMJ, 2016). More than half are preventable and are mainly observed in surgical patients. In conventional hospitalization, excluding intensive care, monitoring is done discontinuously for most of the patients, which does not allow early diagnosis of a vital cardiovascular or respiratory failure.
Diagnosis and late treatment do not allow good recovery. The early identification of a vital failure by the continuous monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) would allow faster management by the hospital staff and a reduction in immediate and possibly delayed postoperative mortality.
Detailed description
The challenge of this research is to transpose in an ordinary hospitalization unit the continuous monitoring of vital functions carried out in intensive care by the continuous measurement of simple parameters using a Connected Medical Device (CMD).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Measurement of 3 constants (SpO2, heart rate and respiratory rate) in patients with a non-ambulatory surgical or interventional act lasting more than 2 hours whose constants are monitored by the reference device in the operating room and the Connected Medical Device.
| Arm | Type | Receives |
|---|---|---|
| Connected Medical Device | Experimental | Device: Connected Medical Device"SMART ANGEL Intra-hospital" System 's Connected Medical Device (DMC) measuring physiological parameters in the operating room |
| Traditional system | Active comparator | Device: Traditional transmission systemTraditional wired transmission system between the sensor and the data processing device in the operating room |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Patients receiving a non-ambulatory surgical or interventional procedure lasting more than 2 hours
- Affiliation with a social security syste, beneficiarie or eligible people (excluding State Medical Assistance (AME))
- Written consent of the patient
Key exclusion criteria (6 listed)
- Patient carrying a multi-resistant germ and placed in isolation
- Patient's known linguistic inability to understand the study
- Non-ambulatory surgical or interventional act in an emergency situation
- Patients under legal protection : curatorship or guardianship
- Known pregnancy or nursing woman
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 |
|---|---|---|
| Connected Medical DeviceMonitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) with a Connected Medical Device (DMC) in the operating room | Device | Connected Medical Device |
| Traditional transmission systemMonitoring of physiological parameters with a traditional wired transmission system between the sensor and the data processing device in the operating room | Device | Traditional system |
Primary outcome
Agreement between the values measurements produced by the traditional monitoring system in the operating theater and the connected medical device of the "SMART ANGEL intra-hospital" system
Time frame: at 2 hours
4 secondary outcomes
Evaluation of missing data due to device malfunction
Time frame: at 2 hours
Nurse satisfaction (System Usability Scale)
Time frame: at 2 hours
Occurrence of events during the course of the study
Time frame: at 2 hours
Time needed by the nursing staff to set up the system
Time frame: at 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
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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.
Jean-Louis MARTY, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connected Medical Device and Traditional transmission system in people with Medical Device, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Louis MARTY, MD, PhD (01 49 81 43 45 ext. +33, jean.marty@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between the values measurements produced by the traditional monitoring system in the operating theater and the connected medical device of the "SMART ANGEL intra-hospital" system (time frame: at 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 Dec 2020.