Evaluation of the Therapeutic Usability of RESPIRA ADVANCED Device in Patients Under Invasive Mechanical Ventilation (RESPIRA-02)

Fundacion Clinic per a la Recerca Biomédica

Status: Unknown

Conditions: Respiratory Insufficiency

Treatments: Device: RESPIRA device.com® Advanced

Study type: Interventional

Funder types: Other

Identifiers

NCT05174130

RESPIRA-02

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Patients undergoing mechanical ventilation in stable phase

Experimental group

Description:

15 Patients will be changed from a basal reference ventilator to the RESPIRA ADVANCED device. The patient will be ventilated for the next 24 hours with the investigational medical device or until one withdrawal criteria is met according to clinical investigation plan. After 24 hours of ventilation with the investigational medical device, the patient will be changed to the previous conventional ventilation device.

Treatment:

Device: RESPIRA device.com® Advanced

Patients undergoing mechanical ventilation in weaning phase

Experimental group

Description:

15 Patients will be changed from a basal reference ventilator to the RESPIRA ADVANCED device. The patient will be ventilated for the next 24 hours with the investigational medical device or until one withdrawal criteria is met according to clinical investigation plan. After 24 hours of ventilation with the investigational medical device, the patient will be changed to the previous conventional ventilation device.

Treatment:

Device: RESPIRA device.com® Advanced