Technical Capabilities of the "SMART ANGEL Intra-hospital" System 's Connected Medical Device (CMD) (SMART-METRO)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Créteil, Frankrike, 94 010
- Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Enhetens genomförbarhet
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Connected Medical Device
"SMART ANGEL Intra-hospital" System 's Connected Medical Device (DMC) measuring physiological parameters in the operating room
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Monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) with a Connected Medical Device (DMC) in the operating room
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Aktiv komparator: Traditional system
Traditional wired transmission system between the sensor and the data processing device in the operating room
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Monitoring of physiological parameters with a traditional wired transmission system between the sensor and the data processing device in the operating room
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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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
Tidsram: at 2 hours
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at 2 hours
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Evaluation of missing data due to device malfunction
Tidsram: at 2 hours
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at 2 hours
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Nurse satisfaction (System Usability Scale)
Tidsram: at 2 hours
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at 2 hours
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Occurrence of events during the course of the study
Tidsram: at 2 hours
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at 2 hours
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Time needed by the nursing staff to set up the system
Tidsram: at 2 hours
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at 2 hours
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Jean-Louis MARTY, MD, PhD, Assistance Publique - Hôpitaux de Paris
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- APHP190708
- 2019-A02197-50 (Annan identifierare: N° IDRCB)
Läkemedels- och apparatinformation, studiedokument
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