NCT05778292

Brief Summary

The purpose of this study is to investigate the feasibility of using electric impedance tomography (EIT) to monitor lung perfusion during veno-venous (VV) extracopreal membrane oxygenation (ECMO) support, as well as the effect of different ECMO flows on lung perfusion monitored by EIT.

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
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

February 8, 2023

Last Update Submit

March 18, 2023

Conditions

Keywords

VV ECMOEITLung perfusion

Outcome Measures

Primary Outcomes (1)

  • Lung perfusion at different VV ECMO flows

    Effect of Different VV ECMO Flows (ECMO flow at 4.5L,3.5L,2.5L,1.5L, and after ECMO withdrawal) on lung perfusion distribution Monitored by EIT

    up to 24hour

Secondary Outcomes (5)

  • Lung ventilation at different VV ECMO flows

    up to 24hour

  • Lung deadspace region at different VV ECMO flows

    up to 24hour

  • Lung shunt region at different VV ECMO flows

    up to 24hour

  • Lung ventilation/perfusion matching at different VV ECMO flows

    up to 24hour

  • Recirculation at different VV ECMO flows

    up to 24hour

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with respiratory failure supported on VV ECMO

You may qualify if:

  • Patients aged ≥ 18 and ≤ 70 years;
  • Patients supported with VV ECMO for respiratory failure;
  • Patients are intubated and mechanically ventilated.

You may not qualify if:

  • EIT contraindications such as chest wound dressing, pacemaker installation, defibrillator, etc;
  • Patients who did not sign the informed consent form;
  • Pulmonary embolism;
  • Pneumothorax;
  • Medium to plenty of chest water;
  • Atrial fibrillation or other malignant arrhythmia leads to a decrease in cardiac output;
  • Refractory shock;
  • Severe chronic heart and lung disease has existed in the past;
  • BMI\>35 kg/m2;
  • Intra-abdominal pressure \>20mmHg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiaobo Yang

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaobo Yang, prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 8, 2023

First Posted

March 21, 2023

Study Start

January 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 21, 2023

Record last verified: 2023-03

Locations