Evaluation of the Therapeutic Usability of RESPIRA ADVANCED Device in Patients Under Invasive Mechanical Ventilation (RESPIRA-02)

March 30, 2022 updated by: Fundacion Clinic per a la Recerca Biomédica

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
        • Contact:
      • Barcelona, Spain, 08024
        • Clínica Nostra Senyora del Remei
        • Contact:
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias y Pujol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Patients undergoing mechanical ventilation in stable phase
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.
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.
EXPERIMENTAL: Patients undergoing mechanical ventilation in weaning phase
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
This variable will be analyzed at the end of the study (36 hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate the failure of the device
Time Frame: 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
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
Evolution of the tidal volume during the ventilation of the patient in hours
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
Evolution of the tidal volume during the ventilation of the patient in hours
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
Evolution of the tidal volume during the ventilation of the patient in hours
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
Evolution of the tidal volume during the ventilation of the patient in hours
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
Evolution of the tidal volume during the ventilation of the patient in hours
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
Evolution of the tidal volume during the ventilation of the patient in hours
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
Evolution of the tidal volume during the ventilation of the patient in hours
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
Evolution of the tidal volume during the ventilation of the patient in hours
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
Evolution of the tidal volume during the ventilation of the patient in hours
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
Evolution of the peak pressure during the ventilation of the patient in hours
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
Evolution of the peak pressure during the ventilation of the patient in hours
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
Evolution of the peak pressure during the ventilation of the patient in hours
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
Evolution of the peak pressure during the ventilation of the patient in hours
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
Evolution of the peak pressure during the ventilation of the patient in hours
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
Evolution of the peak pressure during the ventilation of the patient in hours
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
Evolution of the peak pressure during the ventilation of the patient in hours
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
Evolution of the peak pressure during the ventilation of the patient in hours
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
Evolution of the peak pressure during the ventilation of the patient in hours
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
Evolution of the plateau pressure during the ventilation of the patient in hours
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
Evolution of the plateau pressure during the ventilation of the patient in hours
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
Evolution of the plateau pressure during the ventilation of the patient in hours
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
Evolution of the plateau pressure during the ventilation of the patient in hours
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
Evolution of the plateau pressure during the ventilation of the patient in hours
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
Evolution of the plateau pressure during the ventilation of the patient in hours
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
Evolution of the plateau pressure during the ventilation of the patient in hours
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
Evolution of the plateau pressure during the ventilation of the patient in hours
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
Evolution of the plateau pressure during the ventilation of the patient in hours
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
Evolution of the breathing rate during the ventilation of the patient in hours
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
Evolution of the breathing rate during the ventilation of the patient in hours
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
Evolution of the breathing rate during the ventilation of the patient in hours
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
Evolution of the breathing rate during the ventilation of the patient in hours
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
Evolution of the breathing rate during the ventilation of the patient in hours
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
Evolution of the breathing rate during the ventilation of the patient in hours
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
Evolution of the breathing rate during the ventilation of the patient in hours
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
Evolution of the breathing rate during the ventilation of the patient in hours
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
Evolution of the breathing rate during the ventilation of the patient in hours
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
Evolution of the inspiration-expiration ratio during the ventilation of the patient in hours
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
Evolution of the inspiration-expiration ratio during the ventilation of the patient in hours
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
Evolution of the inspiration-expiration ratio during the ventilation of the patient in hours
This variable will be measured and recorded at 24 hours
Evaluate the pH 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 of pH during the ventilation of the patient
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
Time Frame: This variable will be analyzed at the end of the study (36 hours)
Significant changes of PaCO2 during the ventilation of the patient
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
Time Frame: This variable will be analyzed at the end of the study (36 hours)
Significant changes of oxygen saturation during the ventilation of the patient
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
Time Frame: This variable will be analyzed at the end of the study (36 hours)
Significant changes of heart rate during the ventilation of the patient
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
Time Frame: This variable will be analyzed at the end of the study (36 hours)
Significant changes of breathing during the ventilation of the patient
This variable will be analyzed at the end of the study (36 hours)
Safety Assessment
Time Frame: 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
This variable will be analyzed at the end of the study (36 hours)
Protective Measures Assessment
Time Frame: 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
This variable will be analyzed at the end of the study (36 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacion Clinic per a la Recerca Biomédica

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Josep María Nicolás Arfelis, Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RESPIRA-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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