Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2026-03-20 @ 3:43 PM
Study NCT ID:
NCT06477861
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Elastic Power in Predicting the Severity and Mortality in Adult Patients With ARDS Due to Pneumonia
Sponsor:
Benha University
Organization:
Study Overview
Official Title:
The Role of Elastic Power in Predicting the Severity and Mortality in Adult Patients With Acute Respiratory Distress Syndrome Secondary to Pneumonia
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
the role of elastic power in the prediction of severity and mortality in adults with ARDS secondary to pneumonia
Detailed Description:
Acute respiratory distress syndrome (ARDS) is an acute inflammatory pulmonary disease due to an acute damage of the alveoli, being the most common acute and critical illnesses in intensive critical care medicine.
The international epidemiological LUNGSAFE study shows that the incidence of ARDS in the ICU is approximately 10%, and the mortality rate is still as high as 30-50%, representing a major medical problem facing the society at present .
The Berlin criteria underwent a significant improvement in 2012, and the severity of the disease is graded according to the oxygenation index as compared with the previous ARDS American-European Consensus Conference (AECC) definition .
However, the further research on ARDS in the past ten years revealed that the Berlin standard also has some limitations .
First, investigations found that early oxygenation index (PaO2/FiO2 ratio) may not fully reflect the severity of lung disease in ARDS patients due to the different phases of ARDS progression and the distinctive responses to oxygenation strategy in diseased lung tissues.
Indeed, the disease stratification according to the early PaO2/FiO2 ratio is not effective in predicting the prognosis of patients.
Lung protective ventilation in ARDS involves a variety of respiratory mechanics, such as tidal volume, driving pressure, lung compliance, flow rate, positive end expiratory pressure (PEEP), and respiratory rate.
However, each mechanical parameter alone is too one-sided to reflect the pathogenic factors of ventilator induced lung injury (ventilator induced lung injury) and evaluate the severity of ARDS. Thus, Gattinoni in 2016 introduced the concept of mechanical power (MP) as the power exerted by the ventilator to the entire respiratory system in one minute during mechanical ventilation.
Therefore, MP is a new concept in mechanical ventilation that is being increasingly recognized and studied in the field of critical care medicine. MP consists of three parts :the energy delivered just once when PEEP is applied, the energy applied to overcome airway resistance and finally, the elastic energy delivered at each tidal breath.
Nevertheless, shortcomings also exist in the assessment and quantification of ventilator induced lung injury (VILI) and the degree of lung injury by MP. For example, the energy consumed by the airflow to overcome airway resistance is difficult to link with the alveolar damage, and the energy carried by the airflow itself does not necessarily lead to ventilator induced lung injury (VILI). Airway resistance and peak airway pressure are not significantly associated with VILI, as highlighted by classic lung protective ventilation strategies.
The combined effect of plateau pressure, driving pressure, tidal volume, and changes in lung compliance are the parameters for the prevention of VILI. Among the components of MP, the most closely related to ARDS lung injury might be elastic power (i.e., the power to overcome the elastic resistance of the respiratory system). Elastic energy refers to the energy exerted by the ventilator to overcome the elastic resistance of the respiratory system with a single ventilation and elastic power (EP) is the power exerted by the ventilator to overcome the elastic resistance of the respiratory system in one minute. The EP is comprised of two elements: the energy required to surpass the baseline stretch of the fibers and the energy necessary to overcome the elasticity of the respiratory system with every delivery of tidal volume.
The international epidemiological LUNGSAFE study shows that the incidence of ARDS in the ICU is approximately 10%, and the mortality rate is still as high as 30-50%, representing a major medical problem facing the society at present .
The Berlin criteria underwent a significant improvement in 2012, and the severity of the disease is graded according to the oxygenation index as compared with the previous ARDS American-European Consensus Conference (AECC) definition .
However, the further research on ARDS in the past ten years revealed that the Berlin standard also has some limitations .
First, investigations found that early oxygenation index (PaO2/FiO2 ratio) may not fully reflect the severity of lung disease in ARDS patients due to the different phases of ARDS progression and the distinctive responses to oxygenation strategy in diseased lung tissues.
Indeed, the disease stratification according to the early PaO2/FiO2 ratio is not effective in predicting the prognosis of patients.
Lung protective ventilation in ARDS involves a variety of respiratory mechanics, such as tidal volume, driving pressure, lung compliance, flow rate, positive end expiratory pressure (PEEP), and respiratory rate.
However, each mechanical parameter alone is too one-sided to reflect the pathogenic factors of ventilator induced lung injury (ventilator induced lung injury) and evaluate the severity of ARDS. Thus, Gattinoni in 2016 introduced the concept of mechanical power (MP) as the power exerted by the ventilator to the entire respiratory system in one minute during mechanical ventilation.
Therefore, MP is a new concept in mechanical ventilation that is being increasingly recognized and studied in the field of critical care medicine. MP consists of three parts :the energy delivered just once when PEEP is applied, the energy applied to overcome airway resistance and finally, the elastic energy delivered at each tidal breath.
Nevertheless, shortcomings also exist in the assessment and quantification of ventilator induced lung injury (VILI) and the degree of lung injury by MP. For example, the energy consumed by the airflow to overcome airway resistance is difficult to link with the alveolar damage, and the energy carried by the airflow itself does not necessarily lead to ventilator induced lung injury (VILI). Airway resistance and peak airway pressure are not significantly associated with VILI, as highlighted by classic lung protective ventilation strategies.
The combined effect of plateau pressure, driving pressure, tidal volume, and changes in lung compliance are the parameters for the prevention of VILI. Among the components of MP, the most closely related to ARDS lung injury might be elastic power (i.e., the power to overcome the elastic resistance of the respiratory system). Elastic energy refers to the energy exerted by the ventilator to overcome the elastic resistance of the respiratory system with a single ventilation and elastic power (EP) is the power exerted by the ventilator to overcome the elastic resistance of the respiratory system in one minute. The EP is comprised of two elements: the energy required to surpass the baseline stretch of the fibers and the energy necessary to overcome the elasticity of the respiratory system with every delivery of tidal volume.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: