Evaluation of Membrane Lung Function in High-altitude Reg... | NCT06152744

Studies
Evaluation of Membrane Lung Function in High-altitude Regions

NCT06152744

Sponsor

Beijing Chao Yang Hospital

Status

Recruiting

Last Update Posted

Jun 17, 2025Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Extracorporeal Membrane Oxygenation
Membrane Lung Function
High Altitude

Interventions

Monitoring membrane lung function at different altitudes

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2023Actual

Primary Completion Date

Dec 30, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Nov 22, 2023

First Submission Date that Met QC Criteria

Nov 22, 2023

First Posted Date

Dec 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2025

Last Update Posted Date

Jun 17, 2025Actual

Name	Class
Affiliated Hospital of Qinghai University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High-altitude group			Other: Monitoring membrane lung function at different altitudes
Low-altitude group			Other: Monitoring membrane lung function at different altitudes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who are supported by ECMO

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hua Yang, Dr.	Contact	+8618601342030		xuanben1985@163.com

Overall Officials

Name	Affiliation	Role
Rui Wang, Dr.	Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Chao-Yang Hospital	Recruiting	Beijing	Beijing Municipality	100020	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33256824	Background	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.

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases