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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778292
• Other study ID #: ECMO20221119
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Wuhan Union Hospital, China
• Contact: Xiaobo Yang, prof.
• Phone: 008602785351606
• Email: want.tofly[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness

Locations

Country	Name	City	State
China	Xiaobo Yang	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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