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Effects of Different Driving Pressure on Lung Stress, Strain and Mechanical Power in Patients With Moderate to Severe ARDS

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ClinicalTrials.gov Identifier: NCT03616704
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Jianfeng Xie, Southeast University, China

Brief 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).

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


Condition or disease
ARDS Driving Pressure Strains Mechanical Power Stress

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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Effects of Different Driving Pressure on Lung Stress, Strain and Mechanical Power in Patients With Moderate to Severe ARDS
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : May 1, 2019



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who are diagnosed ARDS in Southeast University Zhongda hospital and hospitalized in ICU from July 1,2018 to April 1,2018
Criteria

Inclusion Criteria:

  1. diagnosed as moderate to severe ARDS patients(P/F ratio<150mmHg)
  2. ICU hospitalization time is expected to be more than 24 hours

Exclusion Criteria:

  1. patients whose age<18 years old or >75 years old
  2. Severe respiratory central depression, high paraplegia, neuromuscular disease;
  3. esophageal obstruction, perforation, severe upper gastrointestinal bleeding / surgery, hernia, thoracic deformity;
  4. 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;


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616704


Contacts
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Contact: XU LIU, graduated 86-15851837797 1227919775@qq.com
Contact: QIN SUN, DOC

Locations
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China, Jiangsu
Zhongda Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Haibo Qiu, Prof    +862583262550      
Principal Investigator: XU LIU, GRADUATE         
Sponsors and Collaborators
Jianfeng Xie
Investigators
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Study Chair: HAIBO QIU, professor southeast university

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Responsible Party: Jianfeng Xie, physician, sponsor-investigator, Southeast University, China
ClinicalTrials.gov Identifier: NCT03616704     History of Changes
Other Study ID Numbers: 2018ZDSYLL038-Y01
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianfeng Xie, Southeast University, China:
ARDS
strain
stress
Mechanical Power
Additional relevant MeSH terms:
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Sprains and Strains
Wounds and Injuries