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ClinicalTrials.gov ID

NCT05174130

Lead Sponsor

Fundacion Clinic per a la Recerca BiomédicaOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

30Estimated

Last Update Posted

Apr 8, 2022Actual

Start Date

May 1, 2022Estimated

Primary Completion Date

Mar 2023Estimated

Completion Date

Mar 2023Estimated

Official Title

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

Brief 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.

• Respiratory Insufficiency

• RESPIRA device.com® Advanced

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Age equal to or greater than 18 years
• Availability of a family member or legal representative capable of understanding and signing the informed consent
• Patient admitted to the intensive care unit requiring invasive mechanical ventilation, who shows:
• Hemodynamic stability: MAP ≥ 65 mmHg and norepinephrine requirements ≤ 0.5 µg / kg / min, and
• Respiratory stability: PaO2 / Fraction of Inspired Oxygen (FiO2)> 100 and stable oxygen requirements in the previous 6 hours.
• In case is considered to start phase of "weaning" or awakening, the level of sedation should allow adequate triggering of the inspiratory trigger, in a patient with improvement of respiratory failure and / or radiological image.

Exclusion Criteria:

• Age under 18 years
• Weight less than 50 kg
• Body weight greater than 120 kg
• Height greater than 1,90 m
• Presence of barotrauma (pneumothorax) or pleural fistula
• Hemodynamic instability (MAP < 65 mmHg or norepinephrine requirements > 0,5 µg /kg / min)
• Neurocritical patient
• Obstetric patient

Primary Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Fundacion Clinic per a la Recerca BiomédicaOTHER

dbeltran@clinic.cat+34627988922