Evaluation of the Therapeutic Usability of RESPIRA ADVANCED Device in Patients Under Invasive Mechanical Ventilation
- Conditions
- Respiratory Insufficiency
- Interventions
- Device: RESPIRA device.com® Advanced
- Registration Number
- NCT05174130
- Lead Sponsor
- Fundacion Clinic per a la Recerca Biomédica
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients undergoing mechanical ventilation in stable phase RESPIRA device.com® Advanced 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. Patients undergoing mechanical ventilation in weaning phase RESPIRA device.com® Advanced 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.
- Primary Outcome Measures
Name Time Method Evaluate blood oxygen pressure (PaO2) changes of patients during the ventilation procedure compared to baseline ventilation This variable will be analyzed at the end of the study (36 hours) Significant changes in PaO2 during the ventilation of the patient
- Secondary Outcome Measures
Name Time Method Evaluate the reliability and temporal consistency of the tidal volume of the device This variable will be measured and recorded at 24 hours Evolution of the tidal volume during the ventilation of the patient in hours
Evaluate the reliability and temporal consistency of the breathing rate of the device This variable will be measured and recorded at 24 hours Evolution of the breathing rate during the ventilation of the patient in hours
Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm This variable will be measured and recorded at 24 hours Evolution of the inspiration-expiration ratio during the ventilation of the patient in hours
Evaluate the oxygen saturation changes of patients during the ventilation procedure compared to baseline ventilation This variable will be analyzed at the end of the study (36 hours) Significant changes of oxygen saturation during the ventilation of the patient
Safety Assessment This variable will be analyzed at the end of the study (36 hours) Number of device related serious and unexpected adverse events reported during the use of the device
Evaluate the reliability and temporal consistency of the peak pressure of the device This variable will be measured and recorded at 24 hours Evolution of the peak pressure during the ventilation of the patient in hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device This variable will be measured and recorded at 24 hours Evolution of the plateau pressure during the ventilation of the patient in hours
Evaluate the pH changes of patients during the ventilation procedure compared to baseline ventilation This variable will be analyzed at the end of the study (36 hours) Significant changes of pH during the ventilation of the patient
Evaluate the breathing rate changes of patients during the ventilation procedure compared to baseline ventilation This variable will be analyzed at the end of the study (36 hours) Significant changes of breathing during the ventilation of the patient
Protective Measures Assessment This variable will be analyzed at the end of the study (36 hours) Number of alarms activated by the investigational device during the ventilation procedure
Evaluate the failure of the device This variable will be analyzed at the end of the study (36 hours) Amount of patients that required the use of the conventional ventilator due to a therapeutic failure of the investigational device
Evaluate the blood carbon dioxide pressure (PaCO2) changes of patients during the ventilation procedure compared to baseline ventilation This variable will be analyzed at the end of the study (36 hours) Significant changes of PaCO2 during the ventilation of the patient
Evaluate the heart rate changes of patients during the ventilation procedure compared to baseline ventilation This variable will be analyzed at the end of the study (36 hours) Significant changes of heart rate during the ventilation of the patient
Trial Locations
- Locations (3)
Hospital Universitari Germans Trias y Pujol
🇪🇸Badalona, Barcelona, Spain
Clínica Nostra Senyora del Remei
🇪🇸Barcelona, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain