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

NCT05174130 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-04-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Fundacion Clinic per a la Recerca Biomédica

    lead OTHER

Principal Investigators

  • Josep María Nicolás Arfelis · Hospital Clinic of Barcelona

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Spain

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 NCT05174130 on ClinicalTrials.gov