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

Respiratory Insufficiency Clinical Trial

— RESPIRA-02  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05174130
• Other study ID #: RESPIRA-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: March 2023

Study information

• Verified date: March 2022
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: Daniel Beltran Argudo
• Phone: +34627988922
• Email: dbeltran[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Device:
• RESPIRA device.com® Advanced
Ventilation of patients with continuous monitoring of the patient's clinical parameters and the parameters that the investigational medical device shows.

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias y Pujol	Badalona	Barcelona
Spain	Clínica Nostra Senyora del Remei	Barcelona
Spain	Hospital Clínic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)