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Completed

NCT Number: NCT06181539

Evaluate the Effect of Prone Ventilation on Ventilated-blood Flow Ratio in Patients With ARDS by EIT

Patients with ARDS often suffer a gravity-dependent alveolar collapse, resulting in a reduction of tidal volume, residual alveolar excessive distension, and ventilator-related lung injury(VILI) induced by unreasonable ventilator setting.Prone ventilation (PPV) improves the gravity-dependent alveolar ventilation and promotes lung recruitment in the gravity-dependent area and improves lung compliance. Previous studies showed that prolonged PPV combined with low tidal volume(LTV) lung protected ventilation can significantly reduce the mortality of patients with moderate to severe ARDS.Although more than 60% of patients with moderate to severe ARDS due to COVID-19 has been widely implemented PPV,studies showed an improvement in oxygenation in patients with ARDS(the P/F radio improved by more than 20% before and after PPV) was 9-77%, that is, That is, some patients are unresponsive to PPV. In addition, some patients showed CO2 responsiveness after PPV(ventilation rate (VR) decreased significantly after PPV).The tools for monitoring the effects of PPV on ventilation and blood flow at bedside are still lacking, Electrical impedance tomography (EIT) is a non-invasive, non-radiative, real-time bedside lung imaging technique that can monitor local lung ventilation distribution. This study intends to use EIT to evaluate pulmonary ventilation, blood flow distribution and local V/Q ratio before and after PPV, as well as to monitor the changes in pulmonary physiology before and after PPV, explore the mechanism of PPV improving oxygenation by combined with the changes in oxygenation, and explore the factors that predict and affect PPV responsiveness.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

About this study

Acute respiratory distress syndrome (ARDS) is presented as acute hypoxemia and pulmonary edema due to the increased permeability of alveolar capillaries. Endothelial damage injury and swelling, microthrombosis, and hypoxic pulmonary vasoconstriction can lead to low pulmonary blood vessels perfusion and even occlusion, while patients with ARDS often suffer a gravity-dependent alveolar collapse, resulting in a reduction of tidal volume, residual alveolar excessive distension, and ventilator-related lung injury(VILI) induced by unreasonable ventilator setting.Prone ventilation (PPV) improves the gravity-dependent alveolar ventilation and promotes lung recruitment in the gravity-dependent area and improves lung compliance. Besides, pulmonary blood perfusion is less affected by gravity distribution, thus the improvement of gravity-dependent alveolar ventilation can significantly reduce shunt, and lung heterogeneity and improve V/Q radio. Previous studies showed that prolonged PPV combined with low tidal volume lung protected ventilation can significantly reduce the mortality of patients with moderate to severe ARDS.Although more than 60% of patients with moderate to severe ARDS due to COVID-19 has been widely implemented PPV,studies showed an improvement in oxygenation in patients with ARDS(the P/F radio improved by more than 20% before and after PPV) was 9-77%, that is, That is, some patients are unresponsive to PPV. In addition, some patients showed CO2 responsiveness after PPV (ventilation rate (VR) decreased significantly after PPV).The tools for monitoring the effects of PPV on ventilation and blood flow at bedside are still lacking, Electrical impedance tomography (EIT) is a non-invasive, non-radiative, real-time bedside lung imaging technique that can monitor local lung ventilation distribution. By injecting hypertonic saline through a central vein catheter, we can obtain lung perfusion images to indicate local lung blood flow distribution. In addition, combined with lung ventilation images, we can evaluate the pulmonary shunt, dead space, V/Q ratio, to better clarify the physiological and pathological status of lung.This study intends to use EIT to evaluate pulmonary ventilation, blood flow distribution and local V/Q ratio before and after PPV, as well as to monitor the changes in pulmonary physiology before and after PPV, explore the mechanism of PPV improving oxygenation by combined with the changes in oxygenation, and explore the factors that predict and affect PPV responsiveness.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Age ≥18 years. 2. Patients diagnosed with ARDS according to the Berlin definition and need to endotracheal intubated and mechanical ventilated in prone position within 48 hours of endotracheal intubation 3. PaO2/FiO2 < 150 mmHg with positive end-expiratory pressure (PEEP) ≥ 5 cmH2O according to the Berlin definition.

Exclusion criteria

  • 1. Contraindications of EIT such as chest wound dressing, installation of pacemaker, defibrillator, etc.
  • Unstable vertebral fracture 3. Within 15 days after severe facial trauma or facial surgery 4 within 15 days after tracheal surgery or sternotomy 5. Hemodynamic instability or recent cardiac arrest 6. Increased intraocular pressure. 7. Unstable femoral or pelvic fractures and pelvic external fixation. 8 He had severe chest wall disease and unstable rib fractures. 9 Recent cardiothoracic surgery. 10. Pneumothorax 11. Chronic lung disease: severe obstructive pulmonary disease, severe asthma, interstitial lung disease.
  • Maternal 13. Extracorporeal membrane oxygenation(ECMO) had been administered on admission to the ICU.
  • Intracranial hypertension 15. Pulmonary embolism, acute or chronic right heart failure 16. Severe cardiac dysfunction (New York Heart Association class III or IV, acute coronary syndrome, or sustained ventricular tachyarrhythmia), cardiogenic shock; 17. No informed consent was obtained

Treatment and study plan

Primary outcomes

  1. Pulmonary ventilation perfusion(V/Q) ratio after 16 hours of PPV monitored by EIT

    Time frame: 16 hours after prone position ventilation

    the V/Q radio were monitored by EIT after patients were implemented prone position ventilation(PPV) for 16h. The images of ventilation distribution were collected by EIT, and the images of perfusion distribution were collected by injected 10ml of 10% hypertonic saline through a central vein catheter during inspiratory hold or expiratory hold. The ventilation and perfusion images were analysed by specialized software to obtain the data of V/Q radio.

Secondary outcomes

  1. Pulmonary ventilation perfusion(V/Q) ratio before PPV monitored by EIT before PPV

    Time frame: within 1 hour before preparing PPV

    The V/Q radio were monitored by EIT before patients were implemented prone position ventilation(PPV). The images of ventilation distribution were collected by EIT, and the data of perfusion distribution were collected by injected 10ml of 10% hypertonic saline through a central vein catheter during inspiratory hold or expiratory hold. The ventilation and perfusion images were analysed by specialized software to obtain the data of V/Q radio.

  2. Pulmonary ventilation perfusion(V/Q) ratio after PPV ending 8h monitored by EIT

    Time frame: 8 hours hours after prone position ventilation ending

    the V/Q radio were monitored by EIT 8 hours after prone position ventilation ending.The images of ventilation distribution were collected by EIT, and the data of perfusion distribution were collected by injected 10ml of 10% hypertonic saline through a central vein catheter during inspiratory hold or expiratory hold. The ventilation and perfusion images were analysed by specialized software to obtain the data of V/Q radio.

  3. Pulmonary ventilation distribution before PPV, PPV for 16h and 8h after PPV ending

    Time frame: within 1hour before preparing PPV, 16 hours after and 8 hours after PPV ending

    Pulmonary ventilation distribution were monitored by EIT before PPV, PPV for 16h and 8h after PPV ending. The images of ventilation distribution were collected by EIT and analysed by specialized software to obtain the data.

  4. Pulmonary perfusion distribution before PPV, PPV for 16h and 8h after PPV ending

    Time frame: within 1 hour before preparing PPV, 16 hours after and 8 hours after PPV ending

    The pulmonary perfusion distribution were monitored by EIT before PPV, PPV for 16h and 8h after PPV ending. The images of perfusion distribution were collected by injected 10ml of 10% hypertonic saline through a central vein catheter during inspiratory hold or expiratory hold. The perfusion images were analysed by specialized software to obtain the data of pulmonary perfusion distribution.

  5. Pulmonary shunt percentage before PPV, PPV for 16h and 8h after PPV ending

    Time frame: within 1 hour before preparing PPV, 16 hours after and 8 hours after PPV ending

    The ventilation and perfusion images were analysed by specialized software to obtain the data of pulmonary shunt percentage.

  6. Pulmonary dead space percentage before PPV, PPV for 16h and 8h after PPV ending

    Time frame: within 1 hour before preparing PPV, 16 hours after and 8 hours after PPV ending

    The ventilation and perfusion images were analysed by specialized software to obtain the data of pulmonary dead space percentage.

  7. Peak pressure before PPV, PPV for 16h and 8h after PPV ending

    Time frame: Within 1 hour before preparing PPV, 16 hours after and 8 hours after PPV ending

    Peak pressure data were obtained from ventilators

  8. Plat pressure before PPV, PPV for 16h and 8h after PPV ending

    Time frame: Within 1 hour before preparing PPV, 16 hours after and 8 hours after PPV ending

    Plat pressure data were obtained from ventilators

  9. Tidal volume before PPV, PPV for 16h and 8h after PPV ending

    Time frame: within 1 hour before preparing PPV, 16 hours after and 8 hours after PPV ending

    Tidal volume data were obtained from ventilators

  10. Driving pressure before PPV, PPV for 16h and 8h after PPV ending

    Time frame: within 1 hour before preparing PPV, 16 hours after and 8 hours after PPV ending

    Driving pressure(DP) data were obtained from ventilators

  11. Static compliance(Cs) before PPV, PPV for 16h and 8h after PPV ending

    Time frame: within 1 hour before preparing PPV, 16 hours after and 8 hours after PPV ending

    Cs is equal to tidal volume divided by DP

  12. P/F ratio before PPV, PPV for 16h and 8h after PPV ending

    Time frame: within 1 hour before preparing PPV, 16 hours after and 8 hours after PPV ending

    P/F ratio data were obtain from arterial blood gas analysis

  13. Carbon dioxide partial pressure(PaCO2) before PPV, PPV for 16h and 8h after PPV ending

    Time frame: within 1 hour before preparing PPV, 16 hours after and 8 hours after PPV ending

    PaCO2 data were obtain from arterial blood gas analysis

  14. Ventilatory ratio(VR) before PPV, PPV for 16h and 8h after PPV ending

    Time frame: within 1 hour before preparing PPV, 16 hours after and 8 hours after PPV ending

    VR=[minute ventilation (ml/min)×arterial partial tension of carbon dioxide (mmHg)] / [predicted body weight×100×37.5

  15. 28 days mortality

    Time frame: From the day of enrollment to day 28

    Mortality of from the day of enrollment to day 28

  16. Ventilator free days(VFD) within 28 days

    Time frame: From the day of enrollment to day 28

    The number of ventilator free days for patients from enrollment day to day 28, if patients died within 28 days,VFD was equal to zero.

  17. Mortality in the ICU

    Time frame: From the day of enrollment to the day of transfer from the ICU or death,up to 90 days

    Mortality in the ICU of all participants

  18. Length of stay(LOS)

    Time frame: From the day of to the day of admitting to hospital to depart from the hospital or death,up to 90 days

    LOS(length of stay) of hospital

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Registry information

Official study title

Evaluate the Effect of Prone Ventilation on Ventilated-blood Flow Ratio in Patients With Acute Respiratory Distress Syndrome by Electrical Impedance Tomography

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 26, 2023
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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