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

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

Study Description

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

Study Design

• 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

Groups and Cohorts

Outcome Measures

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.

Eligibility Criteria

• 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;

Contacts and Locations

Contacts

Contact: XU LIU, graduated; 86-15851837797; 1227919775@qq.com

Contact: QIN SUN, DOC

Locations

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

• Study Chair: HAIBO QIU, professor; southeast university

More Information

• Responsible Party: Jianfeng Xie, physician, sponsor-investigator, Southeast University, China
• ClinicalTrials.gov Identifier: NCT03616704
• Other Study ID Numbers: 2018ZDSYLL038-Y01
• First Posted: August 6, 2018
• Last Update Posted: August 6, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Sprains and Strains; Wounds and Injuries