Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04929873
Other study ID # 2020-567
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2022

Study information

Verified date May 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Fei Zeng
Phone 13757119536
Email zengfei@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Establish and verify the feasibility and effectiveness of VA-ECMO remote limb re-perfusion monitoring technology.


Description:

It is proposed to monitor VA-ECMO arterial end side branch circulation in real time through a set of monitoring equipment, guide clinical adjustment, improve lower limb re-perfusion, reduce the occurrence of lower limb ischemia, in order to achieve the goal of early detection, early prevention and early treatment, and provide reference and theoretical basis for clinical practice. Monitoring techniques are divided into two parts: A. monitoring equipment (connecting transdiotic monitoring pressure on va-ECMO side branches cycle); B.to guide clinical adjustment by monitoring pressure (average arterial pressure).


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date December 31, 2022
Est. primary completion date October 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age: adult patients = 18 years of age; - signed ECMO informed consent; - femur vein VA-ECMO treatment; - agreed to establish VA-ECMO side branch cycle; - informed consent to this study. Exclusion Criteria: - a completely closed double lower limb venously before surgery; - amputee

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Closed transdyser
When the average arterial pressure = 50mmHg, it is indicated that the basic blood supply of the lower extremities is satisfied without special treatment, and when the average arterial pressure < 50mmHg, it indicates insufficient perfusion, by adjusting the pipe position, changing the ECMO flow rate, and properly clamping the artery end to divert part of the blood flow to the side branch circulation, so that the average arterial pressure is maintained above 50mmHg.
Routine monitor
Obtain oxygen saturation, skin color, temperature, etc

Locations

Country Name City State
China SAHZhejiangU Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of ischemia Incidence of ischemia of ischemia in the lower extremities on the side of the tube 1 year
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03281707 - NIRS and DO2i Correlation N/A
Completed NCT03001531 - Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia N/A
Recruiting NCT05492968 - The Effect of Epinephrine, Norepinephrine and Phenylephrine on Intraoperative Hemodynamic Performance Phase 4
Completed NCT04144166 - Evaluation of Capillary Refill Index
Completed NCT04081974 - Prevalence and Predictors of Distal Limb Ischemia in Minimally Invasive Cardiac Surgery.
Recruiting NCT03747731 - A Non-invasive Evaluation of Kidney-Lung Interactions
Recruiting NCT06254833 - Microdosing ICG for Serial Colonic Perfusion Study During Surgery N/A
Completed NCT03860493 - Feasibility of the IC-Flow Device for Fluorescent Perfusion Evaluation During Feasibility of the IC-Flow Device
Completed NCT03711916 - Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery N/A
Not yet recruiting NCT06077396 - Does Radial Artery Cannulation Affect the Perfusion Index(PI) of the Hand in Liver Transplant Operations? N/A
Not yet recruiting NCT04907071 - Intravascular Ultrasound for the Evaluation of Malperfusion Syndrome in the Setting of Acute Aortic Dissection N/A
Recruiting NCT04424069 - OCTA Analysis of Macular and Papillary Perfusion After Refractive Surgery in Myopes N/A
Recruiting NCT05276167 - Hyperthermic Intravesical Perfusion for Muscle-invasive Bladder Urothelial Carcinoma N/A
Terminated NCT03715270 - Evaluation of Tissue Oxygen Levels During Breast Reconstruction With a New Surgical Device
Terminated NCT03716050 - The Effect of Nitroglycerin Ointment, Fluorescent Angiography, and Incisional Negative Pressure Wound Therapy on Mastectomy Skin Flap Perfusion-Related Problems Phase 2/Phase 3
Recruiting NCT06019546 - PErfusion QUality ODds
Recruiting NCT06047158 - Effects of Omega-3 Fish Oil Fat Emulsion on Rehabilitation and Immune Function After Radical Surgery Combined With Intraperitoneal Hyperthermic Infusion Chemotherapy in Patients With Locally Advanced Gastric Cancer
Active, not recruiting NCT05517044 - The Pre-acclimatization Augmented Extreme Altitude Expedition N/A
Terminated NCT03843307 - Avazzia-University of Texas Southwestern Medical Center-Tennant Biomodulator® PRO Perfusion Study N/A
Completed NCT06405282 - Weightlessness Associated Cephalad Fluid Shifts; The Potential to Evaluate Venous and Lymphatic Dysfunction