ARDSNCT03616704
Effects of Different Driving Pressure on Lung Stress, Strain and Mechanical Power in Patients With Moderate to Severe ARDS
An observational study of ARDS and Driving Pressure, run by Jianfeng Xie at 1 site in China.
Trial summary
ARDS is the most common acute respiratory failure in the ICU and the mortality rate is still as high as 40%. Mechanical ventilation(MV) is the major supportive treatment for ARDS, but inappropriate ventilator setting could lead to patients suffering from Ventilator-Induced Lung Injury(VILI). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ARDS, Driving Pressure, Strains
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 1 May 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who are diagnosed ARDS in Southeast University Zhongda hospital and hospitalized in ICU from July 1,2018 to April 1,2018
Who may be able to join
- diagnosed as moderate to severe ARDS patients(P/F ratio<150mmHg)
- ICU hospitalization time is expected to be more than 24 hours
Who cannot join
- patients whose age<18 years old or >75 years old
- Severe respiratory central depression, high paraplegia, neuromuscular disease;
- esophageal obstruction, perforation, severe upper gastrointestinal bleeding / surgery, hernia, thoracic deformity;
- patients with severe bullae; 5. Patients with severe coagulopathy;
- 6, severe heart, liver, kidney and other organ failure, hemodynamic instability; 7, the skull base fractures; 8. Other clinical trials are underway;
Trial locations and contacts
1 site in 1 country.
QIN SUN, DOC contact
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital
Nanjing, Jiangsu, 210000
Haibo Qiu, Prof, +862583262550
XU LIU, GRADUATE
About this study
ARDS is the most common acute respiratory failure in the ICU and the mortality rate is still as high as 40%. Mechanical ventilation(MV) is the major supportive treatment for ARDS, but inappropriate ventilator setting could lead to patients suffering from Ventilator-Induced Lung Injury(VILI).
VILI is an important factor in the aggravation of lung injury during MV. The main mechanism of VILI is the unreasonable pressure change (stress) causing excessive local stretch of the lung (strain), which eventually exceeds the capacity of the lung.
Read more
The protective strategies during MV (limited platform pressure, low tidal volume, suitable PEEP) are important means of avoiding VILI during MV. The essences of these strategies are to limit the stress and strain of the lung during MV. However, these lung protective ventilation strategies only start from a single indicator and have certain limitations. Considering the various shortcoming of the current strategies, Amato et al. combined two indicators and proposed the concept of driving pressure(driving pressure=tidal volume/respiratory compliance). Several studies also confirmed that limiting the driving pressure can significantly improve patients' outcomes. But the concept of driving pressure and its safety threshold have certain limitations.
Taking into the limitations of existing low tidal volume, limited platform pressure, and restricted driving pressure strategies in lung protection ventilation, Gattinoni et al. first integrated the all factors such as driving pressure, respiratory rate, airway resistance, respiratory rate and PEEP together and the concept of mechanical power was formally proposed.There is a good correlation between mechanical power and lung strain in a certain PEEP range. Cressoni et al. demonstrated through animal experiments that excessive mechanical power during MV caused significant VILI in animals; Guérin et al. also found that mechanical power was closely related to patient outcome in patients with ARDS. Not only that, but Gattinoni reanalyzed Güldner's experimental data and found that mechanical power is more valuable in reflecting lung damage than driving pressure. Mechanical power is a good indicator of response to patient VILI.
Therefore, the investigators hypothesized that only limiting the driving pressure during MV of patients could not achieve ideal lung protective ventilation. Mechanical power may be a better indicator of response VILI; and the safety threshold of driving pressure based on retrospective analysis may not be suitable for patients with severe ARDS, and a lower driving pressure can protect patients with severe ARDS. This study intends to use a single-center, self-controlled study design to reflect lung injury through stress and strain and mechanical work of the lungs, to verify the safety of different driving pressures for severe ARDS, and to further find a safer driving margin for patients with severe ARDS
- Conditions
- ARDS, Driving Pressure, Strains, Mechanical Power, Stress
- Keywords
- ARDS, strain, stress, Mechanical Power
- Medical subject headings
- Sprains and Strains
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical power has a better correlation with global strain and stress of lung than driving pressure
Global stress(cmH2O) and strain are currently recognized as the gold standards for responding to ventilator-induced lung injury, but it's difficult to monitor in clinic. In fact, small tidal volume(ml), driving pressure(cmH2O), etc. all lung protective ventilation strategies through indirectly reflecting stress and strain. This trial intends to calculate the correlation between the driving pressure and mechanical work(J/min) with stress and strain by changing the tidal volume, using the esophageal pressure（cmH2O） and the end-expiratory volume （cmH2O）of the lung to calculate the stress and strain.
Measured: 15min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Dec 2017
- Primary completion1 Apr 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianfeng Xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianfeng Xie, Southeast University, China
- Investigators
- HAIBO QIU, professor, Study chair, southeast university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616704
- Sponsor's protocol ID
- 2018ZDSYLL038-Y01
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2018
- Last updated
- 6 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Driving Pressure on Lung Stress, Strain and Mechanical Power in Patients With Moderate to Severe ARDS
- ClinicalTrials.gov ID
- NCT03616704
- Acronym / sponsor ID
- 2018ZDSYLL038-Y01
- Conditions
- ARDS, Driving Pressure, Strains, Mechanical Power, Stress
- Keywords
- ARDS, strain, stress, Mechanical Power
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Jianfeng XieUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 6 Aug 2018 (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.
ARDS is the most common acute respiratory failure in the ICU and the mortality rate is still as high as 40%. Mechanical ventilation(MV) is the major supportive treatment for ARDS, but inappropriate ventilator setting could lead to patients suffering from Ventilator-Induced Lung Injury(VILI).
VILI is an important factor in the aggravation of lung injury during MV. The main mechanism of VILI is the unreasonable pressure change (stress) causing excessive local stretch of the lung (strain), which eventually exceeds the capacity of the lung.
The protective strategies during MV (limited platform pressure, low tidal volume, suitable PEEP) are important means of avoiding VILI during MV. The essences of these strategies are to limit the stress and strain of the lung during MV. However, these lung protective ventilation strategies only start from a single indicator and have certain limitations. Considering the various shortcoming of the current strategies, Amato et al. combined two indicators and proposed the concept of driving pressure(driving pressure=tidal volume/respiratory compliance). Several studies also confirmed that limiting the driving pressure can significantly improve patients' outcomes. But the concept of driving pressure and its safety threshold have certain limitations.
Taking into the limitations of existing low tidal volume, limited platform pressure, and restricted driving pressure strategies in lung protection ventilation, Gattinoni et al. first integrated the all factors such as driving pressure, respiratory rate, airway resistance, respiratory rate and PEEP together and the concept of mechanical power was formally proposed.There is a good correlation between mechanical power and lung strain in a certain PEEP range. Cressoni et al. demonstrated through animal experiments that excessive mechanical power during MV caused significant VILI in animals; Guérin et al. also found that mechanical power was closely related to patient outcome in patients with ARDS. Not only that, but Gattinoni reanalyzed Güldner's experimental data and found that mechanical power is more valuable in reflecting lung damage than driving pressure. Mechanical power is a good indicator of response to patient VILI.
Therefore, the investigators hypothesized that only limiting the driving pressure during MV of patients could not achieve ideal lung protective ventilation. Mechanical power may be a better indicator of response VILI; and the safety threshold of driving pressure based on retrospective analysis may not be suitable for patients with severe ARDS, and a lower driving pressure can protect patients with severe ARDS. This study intends to use a single-center, self-controlled study design to reflect lung injury through stress and strain and mechanical work of the lungs, to verify the safety of different driving pressures for severe ARDS, and to further find a safer driving margin for patients with severe ARDS
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who are diagnosed ARDS in Southeast University Zhongda hospital and hospitalized in ICU from July 1,2018 to April 1,2018
Key inclusion criteria (2 listed)
- diagnosed as moderate to severe ARDS patients(P/F ratio<150mmHg)
- ICU hospitalization time is expected to be more than 24 hours
Key exclusion criteria (5 listed)
- patients whose age<18 years old or >75 years old
- Severe respiratory central depression, high paraplegia, neuromuscular disease;
- esophageal obstruction, perforation, severe upper gastrointestinal bleeding / surgery, hernia, thoracic deformity;
- patients with severe bullae; 5. Patients with severe coagulopathy;
- 6, severe heart, liver, kidney and other organ failure, hemodynamic instability; 7, the skull base fractures; 8. Other clinical trials are underway;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mechanical power has a better correlation with global strain and stress of lung than driving pressure
Time frame: 15min
Global stress(cmH2O) and strain are currently recognized as the gold standards for responding to ventilator-induced lung injury, but it's difficult to monitor in clinic. In fact, small tidal volume(ml), driving pressure(cmH2O), etc. all lung protective ventilation strategies through indirectly reflecting stress and strain. This trial intends to calculate the correlation between the driving pressure and mechanical work(J/min) with stress and strain by changing the tidal volume, using the esophageal pressure（cmH2O） and the end-expiratory volume （cmH2O）of the lung to calculate the stress and strain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Individual participant dataSharing planned: 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.
QIN SUN, DOC contact
HAIBO QIU, professor study chair
southeast university
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 ARDS and Driving Pressure, run by Jianfeng Xie at 1 site in China.
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 2 inclusion and 5 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 6 Aug 2018. 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 China. 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 XU LIU, graduated (86-15851837797, 1227919775@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical power has a better correlation with global strain and stress of lung than driving pressure (time frame: 15min). 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 6 Aug 2018.