Clinical trial NCT05174130: Evaluation of the Therapeutic Usability of RESPIRA ADVANCED Device in Patients Under Invasive Mechanical Ventilation
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
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Insufficiency
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 15 patients in stable phase and 15 patients in weaning phase
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Evaluate blood oxygen pressure (PaO2) changes of patients during the ventilation procedure compared to baseline ventilation
timeFrame: This variable will be analyzed at the end of the study (36 hours)
Secondary outcomes:
measure: Evaluate the failure of the device
timeFrame: This variable will be analyzed at the end of the study (36 hours)
measure: Evaluate the reliability and temporal consistency of the tidal volume of the device
timeFrame: This variable will be measured and recorded at 0.33 hours
measure: Evaluate the reliability and temporal consistency of the tidal volume of the device
timeFrame: This variable will be measured and recorded at 0.66 hours
measure: Evaluate the reliability and temporal consistency of the tidal volume of the device
timeFrame: This variable will be measured and recorded at 2 hours
measure: Evaluate the reliability and temporal consistency of the tidal volume of the device
timeFrame: This variable will be measured and recorded at 4 hours
measure: Evaluate the reliability and temporal consistency of the tidal volume of the device
timeFrame: This variable will be measured and recorded at 8 hours
measure: Evaluate the reliability and temporal consistency of the tidal volume of the device
timeFrame: This variable will be measured and recorded at 12 hours
measure: Evaluate the reliability and temporal consistency of the tidal volume of the device
timeFrame: This variable will be measured and recorded at 16 hours
measure: Evaluate the reliability and temporal consistency of the tidal volume of the device
timeFrame: This variable will be measured and recorded at 20 hours
measure: Evaluate the reliability and temporal consistency of the tidal volume of the device
timeFrame: This variable will be measured and recorded at 24 hours
measure: Evaluate the reliability and temporal consistency of the peak pressure of the device
timeFrame: This variable will be measured and recorded at 0.33 hours
measure: Evaluate the reliability and temporal consistency of the peak pressure of the device
timeFrame: This variable will be measured and recorded at 0.66 hours
measure: Evaluate the reliability and temporal consistency of the peak pressure of the device
timeFrame: This variable will be measured and recorded at 2 hours
measure: Evaluate the reliability and temporal consistency of the peak pressure of the device
timeFrame: This variable will be measured and recorded at 4 hours
measure: Evaluate the reliability and temporal consistency of the peak pressure of the device
timeFrame: This variable will be measured and recorded at 8 hours
measure: Evaluate the reliability and temporal consistency of the peak pressure of the device
timeFrame: This variable will be measured and recorded at 12 hours
measure: Evaluate the reliability and temporal consistency of the peak pressure of the device
timeFrame: This variable will be measured and recorded at 16 hours
measure: Evaluate the reliability and temporal consistency of the peak pressure of the device
timeFrame: This variable will be measured and recorded at 20 hours
measure: Evaluate the reliability and temporal consistency of the peak pressure of the device
timeFrame: This variable will be measured and recorded at 24 hours
measure: Evaluate the reliability and temporal consistency of the plateau pressure of the device
timeFrame: This variable will be measured and recorded at 0.33 hours
measure: Evaluate the reliability and temporal consistency of the plateau pressure of the device
timeFrame: This variable will be measured and recorded at 0.66 hours
measure: Evaluate the reliability and temporal consistency of the plateau pressure of the device
timeFrame: This variable will be measured and recorded at 2 hours
measure: Evaluate the reliability and temporal consistency of the plateau pressure of the device
timeFrame: This variable will be measured and recorded at 4 hours
measure: Evaluate the reliability and temporal consistency of the plateau pressure of the device
timeFrame: This variable will be measured and recorded at 8 hours
measure: Evaluate the reliability and temporal consistency of the plateau pressure of the device
timeFrame: This variable will be measured and recorded at 12 hours
measure: Evaluate the reliability and temporal consistency of the plateau pressure of the device
timeFrame: This variable will be measured and recorded at 16 hours
measure: Evaluate the reliability and temporal consistency of the plateau pressure of the device
timeFrame: This variable will be measured and recorded at 20 hours
measure: Evaluate the reliability and temporal consistency of the plateau pressure of the device
timeFrame: This variable will be measured and recorded at 24 hours
measure: Evaluate the reliability and temporal consistency of the breathing rate of the device
timeFrame: This variable will be measured and recorded at 0.33 hours
measure: Evaluate the reliability and temporal consistency of the breathing rate of the device
timeFrame: This variable will be measured and recorded at 0.66 hours
measure: Evaluate the reliability and temporal consistency of the breathing rate of the device
timeFrame: This variable will be measured and recorded at 2 hours
measure: Evaluate the reliability and temporal consistency of the breathing rate of the device
timeFrame: This variable will be measured and recorded at 4 hours
measure: Evaluate the reliability and temporal consistency of the breathing rate of the device
timeFrame: This variable will be measured and recorded at 8 hours
measure: Evaluate the reliability and temporal consistency of the breathing rate of the device
timeFrame: This variable will be measured and recorded at 12 hours
measure: Evaluate the reliability and temporal consistency of the breathing rate of the device
timeFrame: This variable will be measured and recorded at 16 hours
measure: Evaluate the reliability and temporal consistency of the breathing rate of the device
timeFrame: This variable will be measured and recorded at 20 hours
measure: Evaluate the reliability and temporal consistency of the breathing rate of the device
timeFrame: This variable will be measured and recorded at 24 hours
measure: Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm
timeFrame: This variable will be measured and recorded at 8 hours
measure: Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm
timeFrame: This variable will be measured and recorded at 16 hours
measure: Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm
timeFrame: This variable will be measured and recorded at 24 hours
measure: Evaluate the pH changes of patients during the ventilation procedure compared to baseline ventilation
timeFrame: This variable will be analyzed at the end of the study (36 hours)
measure: Evaluate the blood carbon dioxide pressure (PaCO2) changes of patients during the ventilation procedure compared to baseline ventilation
timeFrame: This variable will be analyzed at the end of the study (36 hours)
measure: Evaluate the oxygen saturation changes of patients during the ventilation procedure compared to baseline ventilation
timeFrame: This variable will be analyzed at the end of the study (36 hours)
measure: Evaluate the heart rate changes of patients during the ventilation procedure compared to baseline ventilation
timeFrame: This variable will be analyzed at the end of the study (36 hours)
measure: Evaluate the breathing rate changes of patients during the ventilation procedure compared to baseline ventilation
timeFrame: This variable will be analyzed at the end of the study (36 hours)
measure: Safety Assessment
timeFrame: This variable will be analyzed at the end of the study (36 hours)
measure: Protective Measures Assessment
timeFrame: This variable will be analyzed at the end of the study (36 hours)
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias y Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Clínica Nostra Senyora del Remei
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Josep María Nicolás Arfelis
role: PRINCIPAL_INVESTIGATOR
References: