NCT05380310

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

May 18, 2022

Status Verified

April 1, 2022

Enrollment Period

1.1 years

First QC Date

May 9, 2022

Last Update Submit

May 12, 2022

Conditions

Medical Device

Keywords

Connected Medical DeviceTime to diagnosisPost-operative mortality"SMART ANGEL intra-hospital" system

Outcome Measures

Primary Outcomes (1)

  • 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.

    between inclusion visit and day 30

Secondary Outcomes (13)

  • Mortality during hospitalisation

    between inclusion visit and day 30

  • Mortality within 30 days of surgery

    between inclusion visit and day 30

  • Percentage of transfers to intensive care unit

    between inclusion visit and day 30

  • Length of stay

    between inclusion visit and day 30

  • ICU length of stay

    between inclusion visit and day 30

  • +8 more secondary outcomes

Study Arms (2)

Active alerts

EXPERIMENTAL

"SMART ANGEL Intra-hospital" System with active alerts

Device: Active "SMART ANGEL" solution

Inactive alerts

ACTIVE COMPARATOR

"SMART ANGEL Intra-hospital" System with inactive alerts

Device: Inactive "SMART ANGEL" solution

Interventions

Active "SMART ANGEL" solutionDEVICE

Nurse intervention according to the alert level + traditional monitoring

Active alerts
Inactive "SMART ANGEL" solutionDEVICE

No alert + traditional monitoring + alert in case of imminent life threat

Inactive alerts

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • ASA1 patient (without associated pathology)
  • Patient with a multi-drug resistant germ in isolation
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU Henri Mondor

Créteil, 94010, France

Location

Study Officials

  • Jean-Louis MARTY, MD,PHD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Central Study Contacts

Jean-Louis MARTY, MD,PHD

CONTACT

01 49 81 43 45jean.marty@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2022

First Posted

May 18, 2022

Study Start

June 1, 2022

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

May 18, 2022

Record last verified: 2022-04

Locations

FR(1)