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Evaluation of Membrane Lung Function in High-altitude Regions

Observational Extracorporeal Membrane Oxygenation Membrane Lung Function High Altitude

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In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Monitoring membrane lung function at different altitudes.
Who it may be relevant to
Registry conditions: Extracorporeal Membrane Oxygenation, Membrane Lung Function, High Altitude. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Membrane Lung Function for Patients Receiving Venovenous Extracorporeal Membrane Oxygenation in High-altitude Regions

Overview

Over the last 20 years, extracorporeal membrane oxygenation (ECMO) has been used to support adult patients with respiratory or cardiac failure who are unlikely to survive conventional treatment methods. ECMO circuit, pump, and oxygenator technology improvements permit safer perfusion for extended periods. The prolonged use of an ECMO circuit increases the risk of membrane lung (ML) dysfunction. The ML is responsible for taking in oxygen and removing carbon dioxide. The non-biologic surface of the ML triggers inflammatory and coagulation pathways, resulting in the formation of blood clots, breakdown of fibrin, and activation of white blood cells, which ultimately leads to ML dysfunction. Coagulation and fibrinolysis activation can cause systemic coagulopathy or hemolysis, and the deposition of blood clots can block blood flow. Moreover, the accumulation of moisture in the gas phase and the buildup of protein and cellular debris in the blood phase may contribute to shunt and dead-space physiology, respectively, impairing the exchange of gases. These three categories-hematologic abnormalities, mechanical obstruction, and inadequate gas exchange-account for most ML exchanges. Worsening oxygenation during ECMO should prompt quantification of oxygen transfer. ML exchange is indicated when the ML can no longer meet the patient's oxygen demand. The partial pressure of Post-ML arterial oxygen less than 200 mmHg is the most important consideration in this decision. In some high-altitude regions of China, ECMO treatment is also routinely conducted. The experiences above are derived from low-altitude areas, and whether they apply in high-altitude regions is still being determined. This study aimed to explore the significantly lower membrane lung oxygen uptake in high-altitude regions compared to low-altitude areas.

Interventions

  • Other Monitoring membrane lung function at different altitudes
    The altitude in Beijing is 100m, while the altitude in Xining, Qinghai is 2600m. We will monitor the partial pressure of post-ML arterial oxygen in ECMO patients in these two locations and evaluate whether the normal values of membrane lung function are consistent in different altitudes.

Primary outcome measures

  • Initial assessment of membrane lung oxygen uptake [Time frame: On the third day of ECMO support]
Secondary outcome measures (1)
  • 60-day mortality [Time frame: After patients enrolled 60 days]

Eligibility criteria

Inclusion criteria

  • Receiving ECMO support

Exclusion criteria

  • Unable to obtain post-membrane blood gas
  • Pregnancy
  • Patients cannot receive anticoagulation
  • Refusal to participate in the trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Chao-Yang Hospital — Beijing

Publications

  • Zakhary B, Vercaemst L, Mason P, Antonini MV, Lorusso R, Brodie D. How I approach membrane lung dysfunction in patients receiving ECMO. Crit Care. 2020 Nov 30;24(1):671. doi: 10.1186/s13054-020-03388-2. No abstract available. PMID 33256824

Identifiers

NCT: NCT06152744 · 2023-KE-1121

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗