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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Créteil, Frankrike, 94 010
- Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Enhetens gjennomførbarhet
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Connected Medical Device
"SMART ANGEL Intra-hospital" System 's Connected Medical Device (DMC) measuring physiological parameters in the operating room
|
Monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) with a Connected Medical Device (DMC) in the operating room
|
|
Aktiv komparator: Traditional system
Traditional wired transmission system between the sensor and the data processing device in the operating room
|
Monitoring of physiological parameters with a traditional wired transmission system between the sensor and the data processing device in the operating room
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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
Tidsramme: at 2 hours
|
at 2 hours
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Evaluation of missing data due to device malfunction
Tidsramme: at 2 hours
|
at 2 hours
|
|
Nurse satisfaction (System Usability Scale)
Tidsramme: at 2 hours
|
at 2 hours
|
|
Occurrence of events during the course of the study
Tidsramme: at 2 hours
|
at 2 hours
|
|
Time needed by the nursing staff to set up the system
Tidsramme: at 2 hours
|
at 2 hours
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Jean-Louis MARTY, MD, PhD, Assistance Publique - Hôpitaux de Paris
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- APHP190708
- 2019-A02197-50 (Annen identifikator: N° IDRCB)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .