Evaluation of Membrane Lung Function in High-altitude Regions

Recruiting

• Conditions: Extracorporeal Membrane Oxygenation; High Altitude; Membrane Lung Function
• Interventions: Other: Monitoring membrane lung function at different altitudes

• Registration Number: NCT06152744
• Lead Sponsor: Beijing Chao Yang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-11-22
• Study First Posted: 2023-12-01
• Study Start: 2023-12-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-08
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-04-30
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low-altitude group	Monitoring membrane lung function at different altitudes	-
High-altitude group	Monitoring membrane lung function at different altitudes	-

Primary Outcome Measures

Name	Time	Method
Initial assessment of membrane lung oxygen uptake	On the third day of ECMO support	O2 content of post-ML blood - O2 content of pre-ML blood

Secondary Outcome Measures

Name	Time	Method
60-day mortality	After patients enrolled 60 days	Mortality rate at 60 days of VV-ECMO support

Trial Locations

Locations (1)

Beijing Chao-Yang Hospital; 🇨🇳 Beijing, Beijing, China