NCT04340414

Brief Summary

assess the safety and effectiveness of using low-flow extracorporeal membrane oxygenation(CO2 removal) driving by CVVH machine in the severe NCP patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

6 months

First QC Date

March 3, 2020

Last Update Submit

June 13, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • PaCO2

    PaCO2 from blood gas analysis

    Day 1

  • Driving Pressure

    Driving Pressure monitor by ventilator

    Day 1

  • Tidal volume

    Tidal volume monitor by ventilator

    Day 1

Study Arms (1)

NCP patient with severe ARDS and/or high ventilator supported

EXPERIMENTAL

The NCP patient with severe ARDS and/or high ventilator supported condition was eligibilitable for enrollment

Device: Low flow ECMO driving by CVVH machine

Interventions

With aim to clear CO2 and improve oxygenation, a low flow ECMO treatment(using oxgyenator membrane of kid type ) driving by CVVH machine will be performed in the NCP with severe ARDS

NCP patient with severe ARDS and/or high ventilator supported

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. NCP with severe acute respiratory distress syndrome with ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FiO2)\<150 and PEEP \>10cmH2O
  • \. Driving pressure\> 20cmH2O
  • \. RR\>30bpm
  • PaCO2\>55cmH2O and/or PH\>7.3

You may not qualify if:

  • \. poor venous vascular condition and unavaible for central venous catheter placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yun Long

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

  • Ding X, Chen H, Zhao H, Zhang H, He H, Cheng W, Wang C, Jiang W, Ma J, Qin Y, Liu Z, Wang J, Yan X, Li T, Zhou X, Long Y, Zhang S. ECCO2R in 12 COVID-19 ARDS Patients With Extremely Low Compliance and Refractory Hypercapnia. Front Med (Lausanne). 2021 Jul 8;8:654658. doi: 10.3389/fmed.2021.654658. eCollection 2021.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yun Long

    Peking Union Medical College Hospit

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2020

First Posted

April 9, 2020

Study Start

February 20, 2020

Primary Completion

August 15, 2020

Study Completion

October 15, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations