Clinical trial NCT03763890: Post- End- Expiratory Pressure Affect the Alveolar Heterogeneity in Moderate and Sever ARDS Patients
Official title: Post- End- Expiratory Pressure Affect the Alveolar Heterogeneity in Moderate and Sever ARDS Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ards
Keywords: 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)
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moderate or sever ARDS in 2012 \<Berlin definition\>;

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.

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.

Eligibility 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。

Primary outcomes:
measure: alveolar hyper-distention; alveolar collapse；alveolar opening and closing；
timeFrame: September,1,2018-December 30, 2020
measure: Trans-pulmonary pressure
timeFrame: September,1,2018-December 30, 2020
measure: EELV
timeFrame: September,1,2018-December 30, 2020
measure: peak pressure
timeFrame: September,1,2018-December 30, 2020
measure: plateau pressure
timeFrame: September,1,2018-December 30, 2020
measure: tidal volume
timeFrame: September,1,2018-December 30, 2020
measure: respiratory rate
timeFrame: September,1,2018-December 30, 2020
measure: flow
timeFrame: September,1,2018-December 30, 2020
measure: FiO2
timeFrame: September,1,2018-December 30, 2020
measure: PaO2
timeFrame: September,1,2018-December 30, 2020
measure: PaCO2
timeFrame: September,1,2018-December 30, 2020
Secondary outcomes:
measure: SBP
timeFrame: September,1,2018-December 30, 2020
measure: DBP
timeFrame: September,1,2018-December 30, 2020
measure: CVP
timeFrame: September,1,2018-December 30, 2020
measure: vasopressor
timeFrame: September,1,2018-December 30, 2020
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Zhong-Da Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China
name: haibo qiu, PhD
role: STUDY_DIRECTOR
References: