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

NCT ID: NCT05174130

Last Updated: 2022-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-03-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

RESPIRA device.com® Advanced

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

RESPIRA device.com® Advanced

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion Clinic per a la Recerca Biomédica

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Josep María Nicolás Arfelis

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

Hospital Universitari Germans Trias y Pujol

Badalona, Barcelona, Spain

Clínica Nostra Senyora del Remei

Barcelona, , Spain

Hospital Clínic de Barcelona

Barcelona, , Spain

Countries

Spain

Central Contacts

Daniel Beltran Argudo

Role: CONTACT

dbeltran@clinic.cat

+34627988922

Facility Contacts

Daniel Beltran Argudo

Role: primary

dbeltran@clinic.cat

+34627988922

Daniel Beltran Argudo

Role: primary

dbeltran@clinic.cat

+34627988922

Other Identifiers

RESPIRA-02

Identifier Type: -

Identifier Source: org_study_id