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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05174130
Other study ID # RESPIRA-02
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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