Respiratory Insufficiency
Conditions
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.
Interventions
DEVICERESPIRA 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
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
15 patients in stable phase and 15 patients in weaning phase
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the reliability and temporal consistency of the tidal volume of the device | This variable will be measured and recorded at 0.33 hours | Evolution of the tidal volume during the ventilation of the patient in hours |
| Evaluate the reliability and temporal consistency of the peak pressure of the device | This variable will be measured and recorded at 0.33 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 0.33 hours | Evolution of the plateau pressure 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 0.33 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 8 hours | Evolution of the inspiration-expiration ratio 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 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 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 |
| 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 |
| 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 |
| 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 |
| 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 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 |
Countries
Spain
Contacts
Primary ContactDaniel Beltran Argudo
Outcome results
None listed