Medical DeviceSMARTANGELNCT05380310
Impact on the Time to Diagnosis of Serious Postoperative Complications by a Controlled Connected Medical Device
A study testing Active "SMART ANGEL" solution and Inactive "SMART ANGEL" solution 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?
- Active "SMART ANGEL" solution and Inactive "SMART ANGEL" solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to 1 Jul 2023
- 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 scheduled non-ambulatory surgical or interventional procedure
- Affiliation to a social security scheme, beneficiary or entitled person (excluding AME)
- Patient's written consent or of the trusted person in case of physical incapacity
- ASA1 patient (without associated pathology)
- Patient with a multi-drug resistant germ in isolation
Show all 11Show fewer
- Known linguistic inability of the patient to understand the study
- Known pregnancy or breastfeeding woman
- Patients with implantable pacemakers, implantable defibrillators or neurostimulators.
- Person under legal protection or unable to give consent
- Person deprived of liberty by judicial or administrative decision
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
Créteil, 94010
Jean-Louis MARTY, MD,PHD, 01 49 81 43 45 ext. +33, jean.marty@aphp.fr
About this study
Official title: Impact on the Time to Diagnosis of Serious Post-operative Complications of Continuous, Individualised, Alert Monitoring of SpO2, Heart Rate and Respiratory Rate by a Controlled Connected Medical Device (SMART ANGEL Intra )
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 the "SMART ANGEL Intra-hospital" System's (connected medical devices and alerts).
- Conditions
- Medical Device
- Being tested
- Active "SMART ANGEL" solution, Inactive "SMART ANGEL" solution
- Keywords
- Connected Medical Device, Time to diagnosis, 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.
Active "SMART ANGEL" solutionDevice
Nurse intervention according to the alert level + traditional monitoring
Inactive "SMART ANGEL" solutionDevice
No alert + traditional monitoring + alert in case of imminent life threat
| Study group | Role | What they receive |
|---|---|---|
| Active alerts | Experimental | "SMART ANGEL Intra-hospital" System with active alerts Receives: Device: Active "SMART ANGEL" solution |
| Inactive alerts | Active comparator | "SMART ANGEL Intra-hospital" System with inactive alerts Receives: Device: Inactive "SMART ANGEL" solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in response times for nurses
Difference in response times between the two groups as measured by the difference between the exact time of occurrence of the complication and the time of caregiver intervention.
Measured: between inclusion visit and day 30
Secondary outcomes (13)
Mortality during hospitalisation
Within 30 days of the intervention
Measured: between inclusion visit and day 30
Mortality within 30 days of surgery
Measured: between inclusion visit and day 30
Percentage of transfers to intensive care unit
Measured: between inclusion visit and day 30
Length of stay
Measured: between inclusion visit and day 30
ICU length of stay
Measured: between inclusion visit and day 30
Rate of calls to the doctor on duty
Measured: between inclusion visit and day 30
Percentage of re-hospitalization within 30 days
Measured: between inclusion visit and day 30
Percentage of hospitalisations in follow-up care and rehabilitation care units
Measured: between inclusion visit and day 30
Percentage of patients managed at home
Measured: between inclusion visit and day 30
False positive rate
Alert without complication for the patient
Measured: between inclusion visit and day 30
Incremental cost-effectiveness ratio
Measured: between inclusion visit and day 30
Patient acceptability
Quantitative and qualitative assessment of the device's usability by the patient via Questionnaire and interview
Measured: between inclusion visit and day 30
Acceptability of care teams
Questionnaire and interview
Measured: between inclusion visit and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,000 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, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380310
- Sponsor's protocol ID
- APHP210932
- Other IDs
- N° IDRCB
- Acronym
- SMARTANGEL
- Status last verified
- Apr 2022
- First submitted
- 9 May 2022
- Last updated
- 18 May 2022
- 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 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on the Time to Diagnosis of Serious Post-operative Complications of Continuous, Individualised, Alert Monitoring of SpO2, Heart Rate and Respiratory Rate by a Controlled Connected Medical Device (SMART ANGEL Intra )
- ClinicalTrials.gov ID
- NCT05380310
- Acronym / sponsor ID
- SMARTANGEL / APHP210932
- Conditions
- Medical Device
- Keywords
- Connected Medical Device, Time to diagnosis, Post-operative mortality, "SMART ANGEL intra-hospital" system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Evolucare Technologies, InES - Innovation Electronic Software
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 18 May 2022 (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 the "SMART ANGEL Intra-hospital" System's (connected medical devices and alerts).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active alerts | Experimental | Device: Active "SMART ANGEL" solution"SMART ANGEL Intra-hospital" System with active alerts |
| Inactive alerts | Active comparator | Device: Inactive "SMART ANGEL" solution"SMART ANGEL Intra-hospital" System with inactive alerts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years
- Patients receiving a scheduled non-ambulatory surgical or interventional procedure
- Affiliation to a social security scheme, beneficiary or entitled person (excluding AME)
- Patient's written consent or of the trusted person in case of physical incapacity
- ASA1 patient (without associated pathology)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Active "SMART ANGEL" solutionNurse intervention according to the alert level + traditional monitoring | Device | Active alerts |
| Inactive "SMART ANGEL" solutionNo alert + traditional monitoring + alert in case of imminent life threat | Device | Inactive alerts |
Primary outcome
Difference in response times for nurses
Time frame: between inclusion visit and day 30
Difference in response times between the two groups as measured by the difference between the exact time of occurrence of the complication and the time of caregiver intervention.
13 secondary outcomes
Mortality during hospitalisation
Time frame: between inclusion visit and day 30
Mortality within 30 days of surgery
Time frame: between inclusion visit and day 30
Percentage of transfers to intensive care unit
Time frame: between inclusion visit and day 30
Length of stay
Time frame: between inclusion visit and day 30
ICU length of stay
Time frame: between inclusion visit and day 30
Rate of calls to the doctor on duty
Time frame: between inclusion visit and day 30
Percentage of re-hospitalization within 30 days
Time frame: between inclusion visit and day 30
Percentage of hospitalisations in follow-up care and rehabilitation care units
Time frame: between inclusion visit and day 30
Percentage of patients managed at home
Time frame: between inclusion visit and day 30
False positive rate
Time frame: between inclusion visit and day 30
Incremental cost-effectiveness ratio
Time frame: between inclusion visit and day 30
Patient acceptability
Time frame: between inclusion visit and day 30
Acceptability of care teams
Time frame: between inclusion visit and day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
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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 study director
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 Active "SMART ANGEL" solution and Inactive "SMART ANGEL" solution 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 11 inclusion and 0 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 18 May 2022. 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?
Difference in response times for nurses (time frame: between inclusion visit and day 30). 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 18 May 2022.