NCT05174130

Evaluation of the Therapeutic Usability of RESPIRA ADVANCED Device in Patients Under Invasive Mechanical Ventilation

Evaluation of the Therapeutic Usability of RESPIRA ADVANCED Device in Patients Under Invasive Mechanical Ventilation in Stable Phase and in Weaning Phase

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fundacion Clinic per a la Recerca Biomédica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the clinical investigation presented is to guarantee the safety and usability of the RESPIRA ADVANCED medical device in patients undergoing mechanical ventilation in the ICU, both stable patients and in the weaning phase. Through the clinical investigation, the reliability and durability of the device, the adequacy of the ventilatory parameters and their consistency over time, and the response of the patients wills be checked. During the entire course of the patient's participation in the study, the patient will be closely monitored following the protocol specifications, to guarantee safety and evaluate the effectiveness of the device.

Conditions

• Respiratory Insufficiency

Interventions

Type	Name	Description
DEVICE	RESPIRA device.com® Advanced	Ventilation of patients with continuous monitoring of the patient's clinical parameters and the parameters that the investigational medical device shows.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2021-12-30
• Last updated: 2022-04-08

Locations

3 sites across 1 country: Spain