Respiration Failure
Conditions
Brief summary
Evaluation of the efficacy and safety of the Rengine extracorporeal cardiopulmonary support system and the ECMO sterile oxygenator in the management of respiratory failure.
Interventions
OTHERECMO
Using ECMO in the management of respiratory failure
Sponsors
Life Shield Medical Technology Co., LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| survival | Day 7 post-treatment |
Countries
China
Outcome results
None listed