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

NCT05174130 | Unknown

• 1 other identifier: RESPIRA-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (47)

• Evaluate the failure of the 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

  This variable will be measured and recorded at 0.33 hours

• Evaluate the reliability and temporal consistency of the tidal volume of the device

  This variable will be measured and recorded at 0.66 hours

• Evaluate the reliability and temporal consistency of the tidal volume of the device

  This variable will be measured and recorded at 2 hours

• Evaluate the reliability and temporal consistency of the tidal volume of the device

  This variable will be measured and recorded at 4 hours

Study Arms (2)

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.

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.

Device: RESPIRA device.com® Advanced

Interventions

RESPIRA device.com® Advanced DEVICE

Ventilation of patients with continuous monitoring of the patient's clinical parameters and the parameters that the investigational medical device shows.

Patients undergoing mechanical ventilation in stable phase; Patients undergoing mechanical ventilation in weaning phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (3)

Hospital Universitari Germans Trias y Pujol

Badalona, Barcelona, 08916, Spain

Location

Clínica Nostra Senyora del Remei

Barcelona, 08024, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Josep María Nicolás Arfelis

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Beltran Argudo

CONTACT

+34627988922; dbeltran@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 15 patients in stable phase and 15 patients in weaning phase

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 30, 2021
• Study Start: May 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)