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

NCT ID: NCT06181539

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 94 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-30
• Study Completion Date: 2025-07-01

Brief Summary

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.

Detailed Description

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.

Conditions

Acute Respiratory Distress Syndrome; Electrical Impedance Tomography; Prone Position Ventilation; Ventilation Perfusion Mismatch

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

2. 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.

12. Maternal 13. Extracorporeal membrane oxygenation(ECMO) had been administered on admission to the ICU.

14. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaojing zou, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Wuhan, Hubei, China

Countries

China

References

Fan E, Brodie D, Slutsky AS. Acute Respiratory Distress Syndrome: Advances in Diagnosis and Treatment. JAMA. 2018 Feb 20;319(7):698-710. doi: 10.1001/jama.2017.21907.

Reference Type: BACKGROUND

PMID: 29466596 (View on PubMed)

Gierhardt M, Pak O, Walmrath D, Seeger W, Grimminger F, Ghofrani HA, Weissmann N, Hecker M, Sommer N. Impairment of hypoxic pulmonary vasoconstriction in acute respiratory distress syndrome. Eur Respir Rev. 2021 Sep 15;30(161):210059. doi: 10.1183/16000617.0059-2021. Print 2021 Sep 30.

Reference Type: BACKGROUND

PMID: 34526314 (View on PubMed)

Guerin C, Albert RK, Beitler J, Gattinoni L, Jaber S, Marini JJ, Munshi L, Papazian L, Pesenti A, Vieillard-Baron A, Mancebo J. Prone position in ARDS patients: why, when, how and for whom. Intensive Care Med. 2020 Dec;46(12):2385-2396. doi: 10.1007/s00134-020-06306-w. Epub 2020 Nov 10.

Reference Type: BACKGROUND

PMID: 33169218 (View on PubMed)

Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

Reference Type: BACKGROUND

PMID: 23688302 (View on PubMed)

Kharat A, Simon M, Guerin C. Prone position in COVID 19-associated acute respiratory failure. Curr Opin Crit Care. 2022 Feb 1;28(1):57-65. doi: 10.1097/MCC.0000000000000900.

Reference Type: BACKGROUND

PMID: 34750322 (View on PubMed)

Scaramuzzo G, Gamberini L, Tonetti T, Zani G, Ottaviani I, Mazzoli CA, Capozzi C, Giampalma E, Bacchi Reggiani ML, Bertellini E, Castelli A, Cavalli I, Colombo D, Crimaldi F, Damiani F, Fusari M, Gamberini E, Gordini G, Laici C, Lanza MC, Leo M, Marudi A, Nardi G, Papa R, Potalivo A, Russo E, Taddei S, Consales G, Cappellini I, Ranieri VM, Volta CA, Guerin C, Spadaro S; ICU-RER COVID-19 Collaboration. Sustained oxygenation improvement after first prone positioning is associated with liberation from mechanical ventilation and mortality in critically ill COVID-19 patients: a cohort study. Ann Intensive Care. 2021 Apr 26;11(1):63. doi: 10.1186/s13613-021-00853-1.

Reference Type: BACKGROUND

PMID: 33900484 (View on PubMed)

Lee HY, Cho J, Kwak N, Choi SM, Lee J, Park YS, Lee CH, Yoo CG, Kim YW, Lee SM. Improved Oxygenation After Prone Positioning May Be a Predictor of Survival in Patients With Acute Respiratory Distress Syndrome. Crit Care Med. 2020 Dec;48(12):1729-1736. doi: 10.1097/CCM.0000000000004611.

Reference Type: BACKGROUND

PMID: 33003079 (View on PubMed)

Clarke J, Geoghegan P, McEvoy N, Boylan M, Ni Choileain O, Mulligan M, Hogan G, Keogh A, McElvaney OJ, McElvaney OF, Bourke J, McNicholas B, Laffey JG, McElvaney NG, Curley GF. Prone positioning improves oxygenation and lung recruitment in patients with SARS-CoV-2 acute respiratory distress syndrome; a single centre cohort study of 20 consecutive patients. BMC Res Notes. 2021 Jan 9;14(1):20. doi: 10.1186/s13104-020-05426-2.

Reference Type: BACKGROUND

PMID: 33422143 (View on PubMed)

Bachmann MC, Morais C, Bugedo G, Bruhn A, Morales A, Borges JB, Costa E, Retamal J. Electrical impedance tomography in acute respiratory distress syndrome. Crit Care. 2018 Oct 25;22(1):263. doi: 10.1186/s13054-018-2195-6.

Reference Type: BACKGROUND

PMID: 30360753 (View on PubMed)

Wang YX, Zhong M, Dong MH, Song JQ, Zheng YJ, Wu W, Tao JL, Zhu L, Zheng X. Prone positioning improves ventilation-perfusion matching assessed by electrical impedance tomography in patients with ARDS: a prospective physiological study. Crit Care. 2022 May 27;26(1):154. doi: 10.1186/s13054-022-04021-0.

Reference Type: BACKGROUND

PMID: 35624489 (View on PubMed)

Fan E, Del Sorbo L, Goligher EC, Hodgson CL, Munshi L, Walkey AJ, Adhikari NKJ, Amato MBP, Branson R, Brower RG, Ferguson ND, Gajic O, Gattinoni L, Hess D, Mancebo J, Meade MO, McAuley DF, Pesenti A, Ranieri VM, Rubenfeld GD, Rubin E, Seckel M, Slutsky AS, Talmor D, Thompson BT, Wunsch H, Uleryk E, Brozek J, Brochard LJ; American Thoracic Society, European Society of Intensive Care Medicine, and Society of Critical Care Medicine. An Official American Thoracic Society/European Society of Intensive Care Medicine/Society of Critical Care Medicine Clinical Practice Guideline: Mechanical Ventilation in Adult Patients with Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2017 May 1;195(9):1253-1263. doi: 10.1164/rccm.201703-0548ST.

Reference Type: BACKGROUND

PMID: 28459336 (View on PubMed)

Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.

Reference Type: BACKGROUND

PMID: 26903337 (View on PubMed)

Langer T, Brioni M, Guzzardella A, Carlesso E, Cabrini L, Castelli G, Dalla Corte F, De Robertis E, Favarato M, Forastieri A, Forlini C, Girardis M, Grieco DL, Mirabella L, Noseda V, Previtali P, Protti A, Rona R, Tardini F, Tonetti T, Zannoni F, Antonelli M, Foti G, Ranieri M, Pesenti A, Fumagalli R, Grasselli G; PRONA-COVID Group. Prone position in intubated, mechanically ventilated patients with COVID-19: a multi-centric study of more than 1000 patients. Crit Care. 2021 Apr 6;25(1):128. doi: 10.1186/s13054-021-03552-2.

Reference Type: BACKGROUND

PMID: 33823862 (View on PubMed)

Other Identifiers

PPVEIT20230502

Identifier Type: -

Identifier Source: org_study_id