NCT04668807

Technical Capabilities of the "SMART ANGEL Intra-hospital" System 's Connected Medical Device (CMD)

Assessment of the Technical Capabilities of the "SMART ANGEL" Intra-hospital System 's Connected Medical Device (CMD)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (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 a Connected Medical Device (CMD).

Conditions

• Medical Device

Interventions

Type	Name	Description
DEVICE	Connected Medical Device	Monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) with a Connected Medical Device (DMC) in the operating room
DEVICE	Traditional transmission system	Monitoring of physiological parameters with a traditional wired transmission system between the sensor and the data processing device in the operating room

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2020-12-16
• Last updated: 2020-12-16

Locations

1 site across 1 country: France