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Post- End- Expiratory Pressure Affect the Alveolar Heterogeneity in Moderate and Sever ARDS Patients

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ClinicalTrials.gov Identifier: NCT03763890
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : February 5, 2021
Sponsor:
Information provided by (Responsible Party):
Ling Liu, Southeast University, China

Study Description
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Brief Summary:
This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI.

Condition or disease Intervention/treatment
Ards Device: Post-end-Expiratory pressure

Detailed Description:
ARDS(Acute respiratory distress syndrome )is common in patients suffering Sepsis, trauma, burning and other sever condition and characterized by diffuse alveolar damage and alveolar heterogeneity.ARDS patient need MV(mechanical ventilation )to maintain oxygenation and need unique MV tragedy to avoid VILI(Ventilator induced Lung injury ).PEEP(post-end-expiratory pressure) is crucial to maintain oxygenation and avoid VILI according to researches. But there are also some other research different voice. This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI.
Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Post- End- Expiratory Pressure Affect the Alveolar Heterogeneity in Moderate and Sever ARDS Patients
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021
Groups and Cohorts
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Intervention Details:
  • Device: Post-end-Expiratory pressure
    Titrate the PEEP from 24 cmH2O to 6 cmH2O, 2 cmH2O/step and record EIT, trans-pulmonary pressure, hemodynamic parameter and Blood-gas analysis.

Outcome Measures
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Primary Outcome Measures :
  1. alveolar hyper-distention; alveolar collapse；alveolar opening and closing； [ Time Frame: September,1,2018-December 30, 2020 ]
    The study use Pulmo Vista 500 device (Drager co.),is intended to perform thoracic bioimpedance measurements by applying the technique of electrical impedance tomography (EIT)to evaluate alveolar hyper-distention(%of the lung volume); alveolar collapse(% of the lung volume)；alveolar opening and closing(% of the lung volume).

  2. Trans-pulmonary pressure [ Time Frame: September,1,2018-December 30, 2020 ]
    The researchers place tube in the esophagus and connect it to transmitter to measure esophageal pressure (mmHg)and calculate trans-pulmonary pressure(mmHg) to evaluate stress

  3. EELV [ Time Frame: September,1,2018-December 30, 2020 ]
    The research use nitrogen wash out to measure EELV（end-expiratory lung volume, ml） to calculate dynamic strain and evaluate the strain

  4. peak pressure [ Time Frame: September,1,2018-December 30, 2020 ]
    The researchers use ventilator to measure peak pressure(cmH2O) in patients with mechanical ventilation and without spontaneous breathing..

  5. plateau pressure [ Time Frame: September,1,2018-December 30, 2020 ]
    The researchers use ventilator to do inspiration pause to measure plateau pressure(cmH2O) in patients with mechanical ventilation and without spontaneous breathing.

  6. tidal volume [ Time Frame: September,1,2018-December 30, 2020 ]
    The researchers use ventilator to measure tidal volume(ml) in patients with mechanical ventilation and without spontaneous breathing..

  7. respiratory rate [ Time Frame: September,1,2018-December 30, 2020 ]
    The researchers record the set respiratory rate(bpm) in patients with mechanical ventilation.

  8. flow [ Time Frame: September,1,2018-December 30, 2020 ]
    The researchers record the set Flow (L/min) in patients with mechanical ventilation.

  9. FiO2 [ Time Frame: September,1,2018-December 30, 2020 ]
    The researchers record the set FiO2 ( fraction of inspiratory oxygen, %) in patients with mechanical ventilation.

  10. PaO2 [ Time Frame: September,1,2018-December 30, 2020 ]
    The researchers use blood gas analysis to measure PaO2( arterial oxygen pressure,mmHg)

  11. PaCO2 [ Time Frame: September,1,2018-December 30, 2020 ]
    The researchers use blood gas analysis to measure PaCO2( arterial carbon dioxide pressure,mmHg) .


Secondary Outcome Measures :
  1. SBP [ Time Frame: September,1,2018-December 30, 2020 ]
    Recording SBP(systolic pressure, mmHg),which is always continuously monitored with invasive pressure monitor.

  2. DBP [ Time Frame: September,1,2018-December 30, 2020 ]
    Recording DBP(Diastolic pressure, mmHg),which is always continuously monitored with invasive pressure monitor.

  3. CVP [ Time Frame: September,1,2018-December 30, 2020 ]
    Recording CVP(central venous Pressure）,which is always discontinuously monitored with jugular pressure monitor mmHg).

  4. vasopressor [ Time Frame: September,1,2018-December 30, 2020 ]
    Recording clinical vasopressor usage including Norepinephrine（ μg/Kg/min;）Epinephrine（μg/Kg/min） Dobutamine （ μg/Kg/min)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Moderate or sever ARDS in 2012 <Berlin definition>;
Criteria

Inclusion Criteria:

  1. Age≥18 or<80；
  2. Moderate or sever ARDS in 2012 <Berlin definition>;
  3. Applied mechanical ventilation;
  4. Consent signed.

Exclusion Criteria:

  1. Asthma or COPD；
  2. Cardiogenic edema；
  3. Sever neutropenia(<500/mm3)；
  4. Hemodynamic astatic: DOPA or Dobutamine >15 µg/kg/ min; NE > 15ug /min；
  5. GCS coma score ≤12；
  6. Thoracic injury or surgery patients contradict EIT ；
  7. Refuse to join in trail；
  8. Included in other clinical trail。
Contacts and Locations
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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): NCT03763890


Contacts
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Contact: ling Liu, Phd 13851435472 liulingdoctor@126.com
Contact: haibo qiu, PhD 13951965301 ext professor haiboq@163.com

Locations
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China, Jiangsu
Nanjing Zhong-Da Hospital Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Ling Liu, MD.    86-25-83272201    liulingdoctor@126.com   
Contact: Haibo Qiu, PhD.,MD.    86-25-83272200    haiboq2000@yahoo.com.cn   
Principal Investigator: ling Liu, Phd         
Sponsors and Collaborators
Southeast University, China
Investigators
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Study Director: haibo qiu, PhD Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China
More Information
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Responsible Party: Ling Liu, Director, Southeast University, China
ClinicalTrials.gov Identifier: NCT03763890    
Other Study ID Numbers: 20181129PEEP
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Ling Liu, Southeast University, China:
ARDS（Acute respiratory syndrome）;
stress;
strain;
Trans-pulmonary pressure;
 FRC(functional residual capacity )
PEEP（post end-expiratory pressure）;
EIT（Electronic impedance tomography）;
RVD(region ventilation delay)