NCT05380310

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

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 )

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2022-05-18
• Last updated: 2022-05-18

Locations

1 site across 1 country: France