Acute Respiratory Distress SyndromeNCT06477861
The Role of Elastic Power in Predicting the Severity and Mortality in Adult Patients With ARDS Due to Pneumonia
An observational study of Acute Respiratory Distress Syndrome, run by Benha University at 1 site in Egypt.
Trial summary
the role of elastic power in the prediction of severity and mortality in adults with ARDS secondary to pneumonia Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- calculation of the elastic power of the lung in case of the ARDS and corolating with the severity index of Berline definition of ARDS in respect to mortality and severity
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jan 2024to 24 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It's the population from which sample size will be non randomly selected. The study will be on ARDS patients who will be admitted to ICU of Benha University hospitals . a) Sample size : The sample size was calculated using G*power software based on a previous study by Xie , who investigated the elastic power as a predictor of ARDS severity. They reported a large effect size of elastic power between mild to moderate and moderate to severe ARDS patients. The minimum sample size needed to detect a large effect size (d = 0.8) between such groups is 70 patients (at least 20 with mild to moderate disease and 50 with severe disease). Alpha and power levels were adjusted at 0.05 and 0.8, respectively
Who may be able to join
- Age from 18 to 65 years (male or female). Patients fulfilling criteria of ARDS as per Berline definition who will be admitted to ICU , intubated and MV more than 48 hours will be included in this study.
- Fulfillment of Criteria of readiness for ARDS as per Berline definition :
- an acute onset (<1 week of a known clinical insult or new or worsening respiratory symptoms),
- respiratory failure not primarily due to hydrostatic edema,
- bilateral opacities on a chest radiograph (not fully explained by effusions, lobar or lung collapse, or nodules), and
- <300 mmHg of the ratio of arterial partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) (PaO2/FiO2) with 5 cm H2O of positive end-expiratory pressure (PEEP) or continuous positive airway pressure. To facilitate the estimation of the ARDS prognosis, the Berline definition classifies the severity of ARDS into 3 categories: mild (200 mmHg < PaO2/FiO2 < 300 mmHg), moderate (100 mm Hg < PaO2/FiO2 <200 mmHg), and severe (PaO2/FiO2 < 100 mmHg).
Who cannot join
- Non intubated ICU admissions
- Non-invasive ventilated patients.
- Age less than 18 years or more than 65 years of age
- Open chest wall trauma.
- Patient requiring Extra Corporal Membrane Oxygenator
- Patients with increased intrabdominal pressure interfering with mechanical ventilator parameters measurements
Trial locations and contacts
1 site in 1 country.
Samar R Mohamed contact
Egypt1 site, 1 recruiting
- Recruiting
Banha University Hospital
Banhā, Al Qalubeyah
Samar R Mohammed, lecturer, +201287793991
Samar R Mohamed, 01287793991
About this study
Official title: The Role of Elastic Power in Predicting the Severity and Mortality in Adult Patients With Acute Respiratory Distress Syndrome Secondary to Pneumonia
the role of elastic power in the prediction of severity and mortality in adults with ARDS secondary to pneumonia
Read the 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.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- calculation of the elastic power of the lung in case of the ARDS and corolating with the severity index of Berline definition of ARDS in respect to mortality and severity
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calculation of the elastic power of the lung in case of the ARDS and corolating with the severity index of Berline definition of ARDS in respect to mortality and severityOther
calculation of variables of the elastic power of the lung from the lung pressures on the ventilator : Elastic power = 0.098 * tidal volume * respiratory rate * 1/2(PEEP+Pplat)
| Study group | Role | What they receive |
|---|---|---|
| mild to moderate ARDS | 100 =< PO2/FiO2 ratio < 300 Receives: Other: calculation of the elastic power of the lung in case of the ARDS and corolating with the severity index of Berline definition of ARDS in respect to mortality and severity | |
| severe ARDS | 100 < PO2/FiO2 ratio Receives: Other: calculation of the elastic power of the lung in case of the ARDS and corolating with the severity index of Berline definition of ARDS in respect to mortality and severity |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 day mortality
- survivors are defined as patients who are discharged from ICU or survive beyond 28 days
Measured: 28 days
Secondary outcomes (1)
elastic power normalized to compliance
investigators will compare the results of the elastic power and the elastic power normalized to compliance with the current criteria of Berlin definition of the severity of ARDS depending on the PO2/FiO2 ratio and the expected mortality to determine which is more accurate in prediction of severity and mortality. Investigators will compare the predicted values of Berline definition in regards to mortality with the values obtained from the elastic power and the elastic power corrected to compliance equations to investigate which was more reliable and accurate.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start24 Jan 2024
- Primary completion24 Sep 2024 (estimated)
- Study completion24 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hossameldin Ahmed Awad, Benha University
- Investigators
- Samar R Mohammed, Study director, lecturer of anaesthesia and critical care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477861
- Sponsor's protocol ID
- MD.11.12.2023
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Elastic Power in Predicting the Severity and Mortality in Adult Patients With Acute Respiratory Distress Syndrome Secondary to Pneumonia
- ClinicalTrials.gov ID
- NCT06477861
- Acronym / sponsor ID
- MD.11.12.2023
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 24 Sep 2024 (estimated)
- Study completion
- 24 Oct 2024 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mild to moderate ARDS | – | Other: calculation of the elastic power of the lung in case of the ARDS and corolating with the severity index of Berline definition of ARDS in respect to mortality and severity100 =< PO2/FiO2 ratio < 300 |
| severe ARDS | – | Other: calculation of the elastic power of the lung in case of the ARDS and corolating with the severity index of Berline definition of ARDS in respect to mortality and severity100 < PO2/FiO2 ratio |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It's the population from which sample size will be non randomly selected. The study will be on ARDS patients who will be admitted to ICU of Benha University hospitals . a) Sample size : The sample size was calculated using G*power software based on a previous study by Xie , who investigated the elastic power as a predictor of ARDS severity. They reported a large effect size of elastic power between mild to moderate and moderate to severe ARDS patients. The minimum sample size needed to detect a large effect size (d = 0.8) between such groups is 70 patients (at least 20 with mild to moderate disease and 50 with severe disease). Alpha and power levels were adjusted at 0.05 and 0.8, respectively
Key inclusion criteria (6 listed)
- Age from 18 to 65 years (male or female). Patients fulfilling criteria of ARDS as per Berline definition who will be admitted to ICU , intubated and MV more than 48 hours will be included in this study.
- an acute onset (<1 week of a known clinical insult or new or worsening respiratory symptoms),
- respiratory failure not primarily due to hydrostatic edema,
- bilateral opacities on a chest radiograph (not fully explained by effusions, lobar or lung collapse, or nodules), and
- <300 mmHg of the ratio of arterial partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) (PaO2/FiO2) with 5 cm H2O of positive end-expiratory pressure (PEEP) or continuous positive airway pressure. To facilitate the estimation of the ARDS prognosis, the Berline definition classifies the severity of ARDS into 3 categories: mild (200 mmHg < PaO2/FiO2 < 300 mmHg), moderate (100 mm Hg < PaO2/FiO2 <200 mmHg), and severe (PaO2/FiO2 < 100 mmHg).
Key exclusion criteria (6 listed)
- Non intubated ICU admissions
- Non-invasive ventilated patients.
- Age less than 18 years or more than 65 years of age
- Open chest wall trauma.
- Patient requiring Extra Corporal Membrane Oxygenator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calculation of the elastic power of the lung in case of the ARDS and corolating with the severity index of Berline definition of ARDS in respect to mortality and severitycalculation of variables of the elastic power of the lung from the lung pressures on the ventilator : Elastic power = 0.098 * tidal volume * respiratory rate * 1/2(PEEP+Pplat) | Other | mild to moderate ARDS, severe ARDS |
Primary outcome
28 day mortality
Time frame: 28 days
- survivors are defined as patients who are discharged from ICU or survive beyond 28 days
1 secondary outcome
elastic power normalized to compliance
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samar R Mohamed contact
Samar R Mohammed study director
lecturer of anaesthesia and critical care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed H Awad, MsC.ICU (+971561707026, ahmedhossam79@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 day mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.