Evaluation of Membrane Lung Function in High-altitude Regions

Sponsor
Beijing Chao Yang Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06152744
Collaborator
Affiliated Hospital of Qinghai University (Other)
40
1
4.8
8.3

Study Details

Study Description

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 making 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 post-membrane oxygen partial pressure in high-altitude regions compared to low-altitude areas.

Condition or Disease Intervention/Treatment Phase
  • Other: Monitoring membrane lung function at different altitudes

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Membrane Lung Function for Patients Receiving Venovenous Extracorporeal Membrane Oxygenation in High-altitude Regions
Anticipated Study Start Date :
Dec 5, 2023
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Partial pressure of post-ML arterial oxygen [Within 3 days after ECMO support]

    The partial pressure of post-ML arterial oxygen in ECMO patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Receiving ECMO support
Exclusion Criteria:
  • Unable to obtain post-membrane blood gas

  • Refusal to participate in the trial

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Chao-Yang Hospital Beijing Beijing China 100020

Sponsors and Collaborators

  • Beijing Chao Yang Hospital
  • Affiliated Hospital of Qinghai University

Investigators

  • Study Director: Rui Wang, Dr., Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rui Wang, Principal Investigator, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT06152744
Other Study ID Numbers:
  • 2023-KE-1121
First Posted:
Dec 1, 2023
Last Update Posted:
Dec 1, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2023