Effect of Different VV ECMO Flows on Lung Perfusion Monitored by EIT

Effect of Different VV ECMO Flows on Lung Perfusion Monitored by EIT: an Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness

Detailed Description

This is a monocentric obsevensional study that uses EIT to monitor lung perfusion during VV ECMO support and the effect of different ECMO flows on lung perfusion as measured by EIT. Patients on VV ECMO who meet the withdrawal criteria as determined by clinical experts will have their ECMO flow gradually reduced. EIT lung ventilation and perfusion monitoring were performed at various ECMO flows.

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Xiaobo Yang
      • Contact: Xiaobo Yang, Prof.; Phone Number: +862785351606; Email: want.tofly@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with respiratory failure supported on VV ECMO

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung ventilation 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 ventilation distribution monitored by EIT	up to 24hour
Lung deadspace region 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 deadspace region monitored by EIT	up to 24hour
Lung shunt region 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 shunt region monitored by EIT	up to 24hour
Lung ventilation/perfusion matching 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 ventilation/perfusion matching monitored by EIT	up to 24hour
Recirculation at different VV ECMO flows	Recirculation at different VV ECMO flows (ECMO flow at 4.5L,3.5L,2.5L,and1.5L)	up to 24hour

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: March 18, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 18, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: EIT; VV ECMO; Lung perfusion
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: ECMO20221119

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No