Respiratory InsufficiencyRESPIRA-02NCT05174130
Evaluation of the Therapeutic Usability of RESPIRA ADVANCED Device in Patients Under Invasive Mechanical Ventilation
A study testing RESPIRA device.com® Advanced in people with Respiratory Insufficiency, run by Fundacion Clinic per a la Recerca Biomédica at 3 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- RESPIRA device.com® Advanced
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesSpain
- Study dates
- 1 May 2022to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitari Germans Trias y Pujol
Badalona, Barcelona, 08916
Clínica Nostra Senyora del Remei
Barcelona, 08024
Daniel Beltran Argudo, +34627988922, dbeltran@clinic.cat
Hospital Clínic de Barcelona
Barcelona, 08036
Daniel Beltran Argudo, +34627988922, dbeltran@clinic.cat
About this study
Official title: Evaluation of the Therapeutic Usability of RESPIRA ADVANCED Device in Patients Under Invasive Mechanical Ventilation in Stable Phase and in Weaning Phase
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.
- Conditions
- Respiratory Insufficiency
- Being tested
- RESPIRA device.com® Advanced
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESPIRA device.com® AdvancedDevice
Ventilation of patients with continuous monitoring of the patient's clinical parameters and the parameters that the investigational medical device shows.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing mechanical ventilation in stable phase | Experimental | 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. Receives: Device: RESPIRA device.com® Advanced |
| Patients undergoing mechanical ventilation in weaning phase | Experimental | 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. Receives: Device: RESPIRA device.com® Advanced |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: This variable will be analyzed at the end of the study (36 hours)
Secondary outcomes (47)
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
Measured: This variable will be analyzed at the end of the study (36 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
Measured: This variable will be measured and recorded at 0.33 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
Measured: This variable will be measured and recorded at 0.66 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
Measured: This variable will be measured and recorded at 2 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
Measured: This variable will be measured and recorded at 4 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
Measured: This variable will be measured and recorded at 8 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
Measured: This variable will be measured and recorded at 12 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
Measured: This variable will be measured and recorded at 16 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
Measured: This variable will be measured and recorded at 20 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
Measured: This variable will be measured and recorded at 24 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
Measured: This variable will be measured and recorded at 0.33 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
Measured: This variable will be measured and recorded at 0.66 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
Measured: This variable will be measured and recorded at 2 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
Measured: This variable will be measured and recorded at 4 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
Measured: This variable will be measured and recorded at 8 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
Measured: This variable will be measured and recorded at 12 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
Measured: This variable will be measured and recorded at 16 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
Measured: This variable will be measured and recorded at 20 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
Measured: This variable will be measured and recorded at 24 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
Measured: This variable will be measured and recorded at 0.33 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
Measured: This variable will be measured and recorded at 0.66 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
Measured: This variable will be measured and recorded at 2 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
Measured: This variable will be measured and recorded at 4 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
Measured: This variable will be measured and recorded at 8 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
Measured: This variable will be measured and recorded at 12 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
Measured: This variable will be measured and recorded at 16 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
Measured: This variable will be measured and recorded at 20 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
Measured: This variable will be measured and recorded at 24 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
Measured: This variable will be measured and recorded at 0.33 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
Measured: This variable will be measured and recorded at 0.66 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
Measured: This variable will be measured and recorded at 2 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
Measured: This variable will be measured and recorded at 4 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
Measured: This variable will be measured and recorded at 8 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
Measured: This variable will be measured and recorded at 12 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
Measured: This variable will be measured and recorded at 16 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
Measured: This variable will be measured and recorded at 20 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
Measured: This variable will be measured and recorded at 24 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
Measured: This variable will be measured and recorded at 8 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
Measured: This variable will be measured and recorded at 16 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
Measured: This variable will be measured and recorded at 24 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
Measured: This variable will be analyzed at the end of the study (36 hours)
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
Measured: This variable will be analyzed at the end of the study (36 hours)
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
Measured: This variable will be analyzed at the end of the study (36 hours)
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
Measured: This variable will be analyzed at the end of the study (36 hours)
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
Measured: This variable will be analyzed at the end of the study (36 hours)
Safety Assessment
Number of device related serious and unexpected adverse events reported during the use of the device
Measured: This variable will be analyzed at the end of the study (36 hours)
Protective Measures Assessment
Number of alarms activated by the investigational device during the ventilation procedure
Measured: This variable will be analyzed at the end of the study (36 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start1 May 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 15 patients in stable phase and 15 patients in weaning phase
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josep María Nicolás Arfelis, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174130
- Sponsor's protocol ID
- RESPIRA-02
- Acronym
- RESPIRA-02
- Status last verified
- Mar 2022
- First submitted
- 8 Nov 2021
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Therapeutic Usability of RESPIRA ADVANCED Device in Patients Under Invasive Mechanical Ventilation in Stable Phase and in Weaning Phase
- ClinicalTrials.gov ID
- NCT05174130
- Acronym / sponsor ID
- RESPIRA-02 / RESPIRA-02
- Conditions
- Respiratory Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 15 patients in stable phase and 15 patients in weaning phase
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing mechanical ventilation in stable phase | Experimental | Device: RESPIRA device.com® Advanced15 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 | Experimental | Device: RESPIRA device.com® Advanced15 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESPIRA device.com® AdvancedVentilation of patients with continuous monitoring of the patient's clinical parameters and the parameters that the investigational medical device shows. | Device | Patients undergoing mechanical ventilation in stable phase, Patients undergoing mechanical ventilation in weaning phase |
Primary outcome
Evaluate blood oxygen pressure (PaO2) changes of patients during the ventilation procedure compared to baseline ventilation
Time frame: This variable will be analyzed at the end of the study (36 hours)
Significant changes in PaO2 during the ventilation of the patient
47 secondary outcomes
Evaluate the failure of the device
Time frame: This variable will be analyzed at the end of the study (36 hours)
Evaluate the reliability and temporal consistency of the tidal volume of the device
Time frame: This variable will be measured and recorded at 0.33 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device
Time frame: This variable will be measured and recorded at 0.66 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device
Time frame: This variable will be measured and recorded at 2 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device
Time frame: This variable will be measured and recorded at 4 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device
Time frame: This variable will be measured and recorded at 8 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device
Time frame: This variable will be measured and recorded at 12 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device
Time frame: This variable will be measured and recorded at 16 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device
Time frame: This variable will be measured and recorded at 20 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device
Time frame: This variable will be measured and recorded at 24 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device
Time frame: This variable will be measured and recorded at 0.33 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device
Time frame: This variable will be measured and recorded at 0.66 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device
Time frame: This variable will be measured and recorded at 2 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device
Time frame: This variable will be measured and recorded at 4 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device
Time frame: This variable will be measured and recorded at 8 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device
Time frame: This variable will be measured and recorded at 12 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device
Time frame: This variable will be measured and recorded at 16 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device
Time frame: This variable will be measured and recorded at 20 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device
Time frame: This variable will be measured and recorded at 24 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Time frame: This variable will be measured and recorded at 0.33 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Time frame: This variable will be measured and recorded at 0.66 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Time frame: This variable will be measured and recorded at 2 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Time frame: This variable will be measured and recorded at 4 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Time frame: This variable will be measured and recorded at 8 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Time frame: This variable will be measured and recorded at 12 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Time frame: This variable will be measured and recorded at 16 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Time frame: This variable will be measured and recorded at 20 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Time frame: This variable will be measured and recorded at 24 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device
Time frame: This variable will be measured and recorded at 0.33 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device
Time frame: This variable will be measured and recorded at 0.66 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device
Time frame: This variable will be measured and recorded at 2 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device
Time frame: This variable will be measured and recorded at 4 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device
Time frame: This variable will be measured and recorded at 8 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device
Time frame: This variable will be measured and recorded at 12 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device
Time frame: This variable will be measured and recorded at 16 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device
Time frame: This variable will be measured and recorded at 20 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device
Time frame: This variable will be measured and recorded at 24 hours
Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm
Time frame: This variable will be measured and recorded at 8 hours
Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm
Time frame: This variable will be measured and recorded at 16 hours
Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm
Time frame: This variable will be measured and recorded at 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep María Nicolás Arfelis principal investigator
Hospital Clinic of Barcelona
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESPIRA device.com® Advanced in people with Respiratory Insufficiency, run by Fundacion Clinic per a la Recerca Biomédica at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Beltran Argudo (+34627988922, dbeltran@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate blood oxygen pressure (PaO2) changes of patients during the ventilation procedure compared to baseline ventilation (time frame: This variable will be analyzed at the end of the study (36 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.