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OpenTrials
Completed

NCT Number: NCT07800325

The Safety and Efficacy of ECMO in the Management of Patients With Respiratory Failure

Evaluation of the efficacy and safety of the Rengine extracorporeal cardiopulmonary support system and the ECMO sterile oxygenator in the management of respiratory failure.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 102300, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18, male or female;
  • Patients with respiratory failure and high Paco2, PH < 7.35;
  • Researchers believe that this product is beneficial for patients undergoing treatment, such as patients with invasive ventilator weaning difficulty, large airway obstruction, etc;
  • Patients or guardians provided written informed consent voluntarily.

Exclusion criteria

  • Oxygenation index <80mmHg;
  • Intracranial hemorrhage or severe irreversible brain injury;
  • Thrombocytopenia;
  • Patients with malignant tumors (expected survival time <1 year);
  • patients unable to receive systemic anticoagulation;
  • Obesity: BMI>40kg/m2;
  • Those with a history of mental illness who were unable to cooperate in completing the trial;
  • During pregnancy and lactation;
  • Patients with allergic or severe allergic constitution to the test equipment;
  • Participated in other interventional device clinical trials within 3 months before this trial
  • Those who were deemed unsuitable to participate in the trial by the investigators.

Treatment and study plan

ECMO

Other

Using ECMO in the management of respiratory failure

Primary outcomes

  1. survival

    Time frame: Day 7 post-treatment

Sponsors and collaborators

Lead sponsor

Life Shield Medical Technology Co., LTD

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.