Evaluation of Membrane Lung Function in High-altitude Regions

NCT06152744 | Recruiting DMC

• 1 other identifier: 2023-KE-1121
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Extracorporeal Membrane Oxygenation; Membrane Lung Function; High Altitude

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 60-day mortality

  After patients enrolled 60 days

Study Arms (2)

High-altitude group

Other: Monitoring membrane lung function at different altitudes

Low-altitude group

Other: Monitoring membrane lung function at different altitudes

Interventions

Monitoring membrane lung function at different altitudes OTHER

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.

High-altitude group; Low-altitude group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are supported by ECMO

You may qualify if:

• Receiving ECMO support

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead
• Affiliated Hospital of Qinghai University: collaborator

Study Sites (1)

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

Related Publications (1)

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Arterial blood gas analysis, blood routine, liver and kidney function, coagulation, and BNP

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Rui Wang, Dr.

  Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China

  STUDY DIRECTOR

Central Study Contacts

Hua Yang, Dr.

CONTACT

+8618601342030; xuanben1985@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: December 5, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)