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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03763890
Enrollment
40
Registered
2018-12-04
Start date
2018-09-01
Completion date
2023-12-30
Last updated
2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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)

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.

Interventions

DEVICEPost-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.

Sponsors

Southeast University, China
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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。

Design outcomes

Primary

MeasureTime frameDescription
PaCO2September,1,2018-December 30, 2020The researchers use blood gas analysis to measure PaCO2( arterial carbon dioxide pressure,mmHg) .
tidal volumeSeptember,1,2018-December 30, 2020The researchers use ventilator to measure tidal volume(ml) in patients with mechanical ventilation and without spontaneous breathing..
respiratory rateSeptember,1,2018-December 30, 2020The researchers record the set respiratory rate(bpm) in patients with mechanical ventilation.
flowSeptember,1,2018-December 30, 2020The researchers record the set Flow (L/min) in patients with mechanical ventilation.
FiO2September,1,2018-December 30, 2020The researchers record the set FiO2 ( fraction of inspiratory oxygen, %) in patients with mechanical ventilation.
PaO2September,1,2018-December 30, 2020The researchers use blood gas analysis to measure PaO2( arterial oxygen pressure,mmHg)
alveolar hyper-distention; alveolar collapse;alveolar opening and closing;September,1,2018-December 30, 2020The 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).
Trans-pulmonary pressureSeptember,1,2018-December 30, 2020The 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
EELVSeptember,1,2018-December 30, 2020The research use nitrogen wash out to measure EELV(end-expiratory lung volume, ml) to calculate dynamic strain and evaluate the strain
peak pressureSeptember,1,2018-December 30, 2020The researchers use ventilator to measure peak pressure(cmH2O) in patients with mechanical ventilation and without spontaneous breathing..
plateau pressureSeptember,1,2018-December 30, 2020The researchers use ventilator to do inspiration pause to measure plateau pressure(cmH2O) in patients with mechanical ventilation and without spontaneous breathing.

Secondary

MeasureTime frameDescription
DBPSeptember,1,2018-December 30, 2020Recording DBP(Diastolic pressure, mmHg),which is always continuously monitored with invasive pressure monitor.
CVPSeptember,1,2018-December 30, 2020Recording CVP(central venous Pressure),which is always discontinuously monitored with jugular pressure monitor mmHg).
vasopressorSeptember,1,2018-December 30, 2020Recording clinical vasopressor usage including Norepinephrine( μg/Kg/min;)Epinephrine(μg/Kg/min) Dobutamine ( μg/Kg/min)
SBPSeptember,1,2018-December 30, 2020Recording SBP(systolic pressure, mmHg),which is always continuously monitored with invasive pressure monitor.

Countries

China

Contacts

Primary Contactling Liu, Phd
liulingdoctor@126.com13851435472
Backup Contacthaibo qiu, PhD
haiboq@163.com13951965301

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026