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Impact on the Time to Diagnosis of Serious Postoperative Complications by a Controlled Connected Medical Device

NCT05380310 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2022-05-18

No results posted yet for this study

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.

Conditions

  • Medical Device

Interventions

DEVICE

Active "SMART ANGEL" solution

Nurse intervention according to the alert level + traditional monitoring

DEVICE

Inactive "SMART ANGEL" solution

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

Sponsors & Collaborators

  • Evolucare Technologies

    collaborator INDUSTRY

  • InES - Innovation Electronic Software

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jean-Louis MARTY, MD,PHD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-07-01
Completion
2023-07-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05380310 on ClinicalTrials.gov