Evaluation of Membrane Lung Function in High-altitude Regions

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

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.

Study Overview

• Status: Recruiting
• Conditions: Extracorporeal Membrane Oxygenation; High Altitude; Membrane Lung Function
• Intervention / Treatment: Other: Monitoring membrane lung function at different altitudes

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Hua Yang, Dr.; Phone Number: +8618601342030; Email: xuanben1985@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Recruiting
      • Beijing Chao-Yang Hospital
      • Contact: Rui Wang, MD; Phone Number: +8618601342030; Email: xuanben1985@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are supported by ECMO

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High-altitude group	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.
Low-altitude group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial assessment of membrane lung oxygen uptake	O2 content of post-ML blood - O2 content of pre-ML blood	On the third day of ECMO support

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
60-day mortality	Mortality rate at 60 days of VV-ECMO support	After patients enrolled 60 days

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital
• Collaborators: Affiliated Hospital of Qinghai University
• Investigators: Study Director: Rui Wang, Dr., Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2023
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Altitude Sickness
• Other Study ID Numbers: 2023-KE-1121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No