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

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiratory Insufficiency

Intervention / Treatment
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* Device: RESPIRA device.com® Advanced


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 15 patients in stable phase and 15 patients in weaning phase
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients undergoing mechanical ventilation in stable phase<br>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. | Device: RESPIRA device.com® Advanced<br>* Ventilation of patients with continuous monitoring of the patient's clinical parameters and the parameters that the investigational medical device shows.<br>|
| Experimental: Patients undergoing mechanical ventilation in weaning phase<br>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. | Device: RESPIRA device.com® Advanced<br>* Ventilation of patients with continuous monitoring of the patient's clinical parameters and the parameters that the investigational medical device shows.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate blood oxygen pressure (PaO2) changes of patients during the ventilation procedure compared to baseline ventilation | Significant changes in PaO2 during the ventilation of the patient | This variable will be analyzed at the end of the study (36 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the failure of the device | Amount of patients that required the use of the conventional ventilator due to a therapeutic failure of the investigational device | This variable will be analyzed at the end of the study (36 hours) | 
| Evaluate the reliability and temporal consistency of the tidal volume of the device | Evolution of the tidal volume during the ventilation of the patient in hours | This variable will be measured and recorded at 0.33 hours | 
| Evaluate the reliability and temporal consistency of the tidal volume of the device | Evolution of the tidal volume during the ventilation of the patient in hours | This variable will be measured and recorded at 0.66 hours | 
| Evaluate the reliability and temporal consistency of the tidal volume of the device | Evolution of the tidal volume during the ventilation of the patient in hours | This variable will be measured and recorded at 2 hours | 
| Evaluate the reliability and temporal consistency of the tidal volume of the device | Evolution of the tidal volume during the ventilation of the patient in hours | This variable will be measured and recorded at 4 hours | 
| Evaluate the reliability and temporal consistency of the tidal volume of the device | Evolution of the tidal volume during the ventilation of the patient in hours | This variable will be measured and recorded at 8 hours | 
| Evaluate the reliability and temporal consistency of the tidal volume of the device | Evolution of the tidal volume during the ventilation of the patient in hours | This variable will be measured and recorded at 12 hours | 
| Evaluate the reliability and temporal consistency of the tidal volume of the device | Evolution of the tidal volume during the ventilation of the patient in hours | This variable will be measured and recorded at 16 hours | 
| Evaluate the reliability and temporal consistency of the tidal volume of the device | Evolution of the tidal volume during the ventilation of the patient in hours | This variable will be measured and recorded at 20 hours | 
| Evaluate the reliability and temporal consistency of the tidal volume of the device | Evolution of the tidal volume during the ventilation of the patient in hours | This variable will be measured and recorded at 24 hours | 
| Evaluate the reliability and temporal consistency of the peak pressure of the device | Evolution of the peak pressure during the ventilation of the patient in hours | This variable will be measured and recorded at 0.33 hours | 
| Evaluate the reliability and temporal consistency of the peak pressure of the device | Evolution of the peak pressure during the ventilation of the patient in hours | This variable will be measured and recorded at 0.66 hours | 
| Evaluate the reliability and temporal consistency of the peak pressure of the device | Evolution of the peak pressure during the ventilation of the patient in hours | This variable will be measured and recorded at 2 hours | 
| Evaluate the reliability and temporal consistency of the peak pressure of the device | Evolution of the peak pressure during the ventilation of the patient in hours | This variable will be measured and recorded at 4 hours | 
| Evaluate the reliability and temporal consistency of the peak pressure of the device | Evolution of the peak pressure during the ventilation of the patient in hours | This variable will be measured and recorded at 8 hours | 
| Evaluate the reliability and temporal consistency of the peak pressure of the device | Evolution of the peak pressure during the ventilation of the patient in hours | This variable will be measured and recorded at 12 hours | 
| Evaluate the reliability and temporal consistency of the peak pressure of the device | Evolution of the peak pressure during the ventilation of the patient in hours | This variable will be measured and recorded at 16 hours | 
| Evaluate the reliability and temporal consistency of the peak pressure of the device | Evolution of the peak pressure during the ventilation of the patient in hours | This variable will be measured and recorded at 20 hours | 
| Evaluate the reliability and temporal consistency of the peak pressure of the device | Evolution of the peak pressure during the ventilation of the patient in hours | This variable will be measured and recorded at 24 hours | 
| Evaluate the reliability and temporal consistency of the plateau pressure of the device | Evolution of the plateau pressure during the ventilation of the patient in hours | This variable will be measured and recorded at 0.33 hours | 
| Evaluate the reliability and temporal consistency of the plateau pressure of the device | Evolution of the plateau pressure during the ventilation of the patient in hours | This variable will be measured and recorded at 0.66 hours | 
| Evaluate the reliability and temporal consistency of the plateau pressure of the device | Evolution of the plateau pressure during the ventilation of the patient in hours | This variable will be measured and recorded at 2 hours | 
| Evaluate the reliability and temporal consistency of the plateau pressure of the device | Evolution of the plateau pressure during the ventilation of the patient in hours | This variable will be measured and recorded at 4 hours | 
| Evaluate the reliability and temporal consistency of the plateau pressure of the device | Evolution of the plateau pressure during the ventilation of the patient in hours | This variable will be measured and recorded at 8 hours | 
| Evaluate the reliability and temporal consistency of the plateau pressure of the device | Evolution of the plateau pressure during the ventilation of the patient in hours | This variable will be measured and recorded at 12 hours | 
| Evaluate the reliability and temporal consistency of the plateau pressure of the device | Evolution of the plateau pressure during the ventilation of the patient in hours | This variable will be measured and recorded at 16 hours | 
| Evaluate the reliability and temporal consistency of the plateau pressure of the device | Evolution of the plateau pressure during the ventilation of the patient in hours | This variable will be measured and recorded at 20 hours | 
| Evaluate the reliability and temporal consistency of the plateau pressure of the device | Evolution of the plateau pressure during the ventilation of the patient in hours | This variable will be measured and recorded at 24 hours | 
| Evaluate the reliability and temporal consistency of the breathing rate of the device | Evolution of the breathing rate during the ventilation of the patient in hours | This variable will be measured and recorded at 0.33 hours | 
| Evaluate the reliability and temporal consistency of the breathing rate of the device | Evolution of the breathing rate during the ventilation of the patient in hours | This variable will be measured and recorded at 0.66 hours | 
| Evaluate the reliability and temporal consistency of the breathing rate of the device | Evolution of the breathing rate during the ventilation of the patient in hours | This variable will be measured and recorded at 2 hours | 
| Evaluate the reliability and temporal consistency of the breathing rate of the device | Evolution of the breathing rate during the ventilation of the patient in hours | This variable will be measured and recorded at 4 hours | 
| Evaluate the reliability and temporal consistency of the breathing rate of the device | Evolution of the breathing rate during the ventilation of the patient in hours | This variable will be measured and recorded at 8 hours | 
| Evaluate the reliability and temporal consistency of the breathing rate of the device | Evolution of the breathing rate during the ventilation of the patient in hours | This variable will be measured and recorded at 12 hours | 
| Evaluate the reliability and temporal consistency of the breathing rate of the device | Evolution of the breathing rate during the ventilation of the patient in hours | This variable will be measured and recorded at 16 hours | 
| Evaluate the reliability and temporal consistency of the breathing rate of the device | Evolution of the breathing rate during the ventilation of the patient in hours | This variable will be measured and recorded at 20 hours | 
| Evaluate the reliability and temporal consistency of the breathing rate of the device | Evolution of the breathing rate during the ventilation of the patient in hours | This variable will be measured and recorded at 24 hours | 
| Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm | Evolution of the inspiration-expiration ratio during the ventilation of the patient in hours | This variable will be measured and recorded at 8 hours | 
| Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm | Evolution of the inspiration-expiration ratio during the ventilation of the patient in hours | This variable will be measured and recorded at 16 hours | 
| Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm | Evolution of the inspiration-expiration ratio during the ventilation of the patient in hours | This variable will be measured and recorded at 24 hours | 
| Evaluate the pH changes of patients during the ventilation procedure compared to baseline ventilation | Significant changes of pH during the ventilation of the patient | This variable will be analyzed at the end of the study (36 hours) | 
| Evaluate the blood carbon dioxide pressure (PaCO2) changes of patients during the ventilation procedure compared to baseline ventilation | Significant changes of PaCO2 during the ventilation of the patient | This variable will be analyzed at the end of the study (36 hours) | 
| Evaluate the oxygen saturation changes of patients during the ventilation procedure compared to baseline ventilation | Significant changes of oxygen saturation during the ventilation of the patient | This variable will be analyzed at the end of the study (36 hours) | 
| Evaluate the heart rate changes of patients during the ventilation procedure compared to baseline ventilation | Significant changes of heart rate during the ventilation of the patient | This variable will be analyzed at the end of the study (36 hours) | 
| Evaluate the breathing rate changes of patients during the ventilation procedure compared to baseline ventilation | Significant changes of breathing during the ventilation of the patient | This variable will be analyzed at the end of the study (36 hours) | 
| Safety Assessment | Number of device related serious and unexpected adverse events reported during the use of the device | This variable will be analyzed at the end of the study (36 hours) | 
| Protective Measures Assessment | Number of alarms activated by the investigational device during the ventilation procedure | This variable will be analyzed at the end of the study (36 hours) |