Back to resultsEvaluation of the Therapeutic Usability of RESPIRA ADVANCED Device in Patients Under Invasive Mechanical Ventilation (RESPIRA-02)
Primary Purpose
Respiratory Insufficiency
Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
RESPIRA device.com® Advanced
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Insufficiency
Eligibility Criteria
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
Sites / Locations
- Hospital Universitari Germans Trias y Pujol
- Clínica Nostra Senyora del Remei
- Hospital Clínic de Barcelona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patients undergoing mechanical ventilation in stable phase
Patients undergoing mechanical ventilation in weaning phase
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Evaluate the pH changes of patients during the ventilation procedure compared to baseline ventilation
Significant changes of pH during the ventilation of the patient
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
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
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
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
Safety Assessment
Number of device related serious and unexpected adverse events reported during the use of the device
Protective Measures Assessment
Number of alarms activated by the investigational device during the ventilation procedure
Full Information
NCT ID
NCT05174130
First Posted
November 8, 2021
Last Updated
March 30, 2022
Sponsor
Fundacion Clinic per a la Recerca Biomédica
1. Study Identification
Unique Protocol Identification Number
NCT05174130
Brief Title
Evaluation of the Therapeutic Usability of RESPIRA ADVANCED Device in Patients Under Invasive Mechanical Ventilation
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion Clinic per a la Recerca Biomédica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
15 patients in stable phase and 15 patients in weaning phase
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients undergoing mechanical ventilation in stable phase
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients undergoing mechanical ventilation in weaning phase
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
RESPIRA device.com® Advanced
Intervention Description
Ventilation of patients with continuous monitoring of the patient's clinical parameters and the parameters that the investigational medical device shows.
Primary Outcome Measure Information:
Title
Evaluate blood oxygen pressure (PaO2) changes of patients during the ventilation procedure compared to baseline ventilation
Description
Significant changes in PaO2 during the ventilation of the patient
Time Frame
This variable will be analyzed at the end of the study (36 hours)
Secondary Outcome Measure Information:
Title
Evaluate the failure of the device
Description
Amount of patients that required the use of the conventional ventilator due to a therapeutic failure of the investigational device
Time Frame
This variable will be analyzed at the end of the study (36 hours)
Title
Evaluate the reliability and temporal consistency of the tidal volume of the device
Description
Evolution of the tidal volume during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 0.33 hours
Title
Evaluate the reliability and temporal consistency of the tidal volume of the device
Description
Evolution of the tidal volume during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 0.66 hours
Title
Evaluate the reliability and temporal consistency of the tidal volume of the device
Description
Evolution of the tidal volume during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 2 hours
Title
Evaluate the reliability and temporal consistency of the tidal volume of the device
Description
Evolution of the tidal volume during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 4 hours
Title
Evaluate the reliability and temporal consistency of the tidal volume of the device
Description
Evolution of the tidal volume during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 8 hours
Title
Evaluate the reliability and temporal consistency of the tidal volume of the device
Description
Evolution of the tidal volume during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 12 hours
Title
Evaluate the reliability and temporal consistency of the tidal volume of the device
Description
Evolution of the tidal volume during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 16 hours
Title
Evaluate the reliability and temporal consistency of the tidal volume of the device
Description
Evolution of the tidal volume during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 20 hours
Title
Evaluate the reliability and temporal consistency of the tidal volume of the device
Description
Evolution of the tidal volume during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 24 hours
Title
Evaluate the reliability and temporal consistency of the peak pressure of the device
Description
Evolution of the peak pressure during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 0.33 hours
Title
Evaluate the reliability and temporal consistency of the peak pressure of the device
Description
Evolution of the peak pressure during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 0.66 hours
Title
Evaluate the reliability and temporal consistency of the peak pressure of the device
Description
Evolution of the peak pressure during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 2 hours
Title
Evaluate the reliability and temporal consistency of the peak pressure of the device
Description
Evolution of the peak pressure during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 4 hours
Title
Evaluate the reliability and temporal consistency of the peak pressure of the device
Description
Evolution of the peak pressure during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 8 hours
Title
Evaluate the reliability and temporal consistency of the peak pressure of the device
Description
Evolution of the peak pressure during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 12 hours
Title
Evaluate the reliability and temporal consistency of the peak pressure of the device
Description
Evolution of the peak pressure during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 16 hours
Title
Evaluate the reliability and temporal consistency of the peak pressure of the device
Description
Evolution of the peak pressure during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 20 hours
Title
Evaluate the reliability and temporal consistency of the peak pressure of the device
Description
Evolution of the peak pressure during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 24 hours
Title
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Description
Evolution of the plateau pressure during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 0.33 hours
Title
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Description
Evolution of the plateau pressure during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 0.66 hours
Title
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Description
Evolution of the plateau pressure during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 2 hours
Title
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Description
Evolution of the plateau pressure during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 4 hours
Title
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Description
Evolution of the plateau pressure during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 8 hours
Title
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Description
Evolution of the plateau pressure during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 12 hours
Title
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Description
Evolution of the plateau pressure during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 16 hours
Title
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Description
Evolution of the plateau pressure during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 20 hours
Title
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Description
Evolution of the plateau pressure during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 24 hours
Title
Evaluate the reliability and temporal consistency of the breathing rate of the device
Description
Evolution of the breathing rate during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 0.33 hours
Title
Evaluate the reliability and temporal consistency of the breathing rate of the device
Description
Evolution of the breathing rate during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 0.66 hours
Title
Evaluate the reliability and temporal consistency of the breathing rate of the device
Description
Evolution of the breathing rate during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 2 hours
Title
Evaluate the reliability and temporal consistency of the breathing rate of the device
Description
Evolution of the breathing rate during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 4 hours
Title
Evaluate the reliability and temporal consistency of the breathing rate of the device
Description
Evolution of the breathing rate during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 8 hours
Title
Evaluate the reliability and temporal consistency of the breathing rate of the device
Description
Evolution of the breathing rate during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 12 hours
Title
Evaluate the reliability and temporal consistency of the breathing rate of the device
Description
Evolution of the breathing rate during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 16 hours
Title
Evaluate the reliability and temporal consistency of the breathing rate of the device
Description
Evolution of the breathing rate during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 20 hours
Title
Evaluate the reliability and temporal consistency of the breathing rate of the device
Description
Evolution of the breathing rate during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 24 hours
Title
Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm
Description
Evolution of the inspiration-expiration ratio during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 8 hours
Title
Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm
Description
Evolution of the inspiration-expiration ratio during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 16 hours
Title
Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm
Description
Evolution of the inspiration-expiration ratio during the ventilation of the patient in hours
Time Frame
This variable will be measured and recorded at 24 hours
Title
Evaluate the pH changes of patients during the ventilation procedure compared to baseline ventilation
Description
Significant changes of pH during the ventilation of the patient
Time Frame
This variable will be analyzed at the end of the study (36 hours)
Title
Evaluate the blood carbon dioxide pressure (PaCO2) changes of patients during the ventilation procedure compared to baseline ventilation
Description
Significant changes of PaCO2 during the ventilation of the patient
Time Frame
This variable will be analyzed at the end of the study (36 hours)
Title
Evaluate the oxygen saturation changes of patients during the ventilation procedure compared to baseline ventilation
Description
Significant changes of oxygen saturation during the ventilation of the patient
Time Frame
This variable will be analyzed at the end of the study (36 hours)
Title
Evaluate the heart rate changes of patients during the ventilation procedure compared to baseline ventilation
Description
Significant changes of heart rate during the ventilation of the patient
Time Frame
This variable will be analyzed at the end of the study (36 hours)
Title
Evaluate the breathing rate changes of patients during the ventilation procedure compared to baseline ventilation
Description
Significant changes of breathing during the ventilation of the patient
Time Frame
This variable will be analyzed at the end of the study (36 hours)
Title
Safety Assessment
Description
Number of device related serious and unexpected adverse events reported during the use of the device
Time Frame
This variable will be analyzed at the end of the study (36 hours)
Title
Protective Measures Assessment
Description
Number of alarms activated by the investigational device during the ventilation procedure
Time Frame
This variable will be analyzed at the end of the study (36 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Beltran Argudo
Phone
+34627988922
Email
dbeltran@clinic.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep María Nicolás Arfelis
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Germans Trias y Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Clínica Nostra Senyora del Remei
City
Barcelona
ZIP/Postal Code
08024
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Beltran Argudo
Phone
+34627988922
Email
dbeltran@clinic.cat
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Beltran Argudo
Phone
+34627988922
Email
dbeltran@clinic.cat
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Therapeutic Usability of RESPIRA ADVANCED Device in Patients Under Invasive Mechanical Ventilation
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