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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05816928
Other study ID # EIT20230403
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 12, 2021
Est. completion date April 12, 2021

Study information

Verified date April 2023
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Prone positioning has been widely used in critical care medicine to improve oxygenation in patients with acute respiratory distress syndrome (ARDS). This study aimed to compare the effect of pronation on lung ventilation-perfusion matching between COVID19-associated acute respiratory distress syndrome (CARDS) and ARDS from other etiologies (non-CARDS) using electrical impedance tomography (EIT).


Description:

In this prospective study, both COVID19-associated ARDS (CARDS) patients and patients with ARDS from other etiologies (non-CARDS) were enrolled. Electrical impedance tomography (EIT) was used to evaluate the changes in ventilation and perfusion between supine and prone positions. Baseline values of the area of DeadSpace, shunt, ventilation-perfusion matching (VQmatch) were identified at the time of enrollment. Within the defined VQmatch region, the global inhomogeneity index (VQmatch-GI) was calculated to assess the degree of uniformity within the region. Prone position was applied immediately after the baseline data were collected. After 2 hours of proning, another EIT examination was conducted. Parameters such as DeadSpace, shunt, VQmatch, and other common measurements before and after pronation were taken and compared to evaluate the effect of prone positioning on CARDS and non-CARDS patients.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date April 12, 2021
Est. primary completion date April 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Above the age of 18 - Diagnosed with ARDS based on the Berlin Definition of ARDS - Under mechanical ventilation Exclusion Criteria: - Contraindications to EIT examination and prone position - Refusal of signing the informed consent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China PUMC Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary DeadSpace The area of Deadspace will be assessed using electrical impedance tomography 3 months
Primary Shunt Shunt will be assessed using electrical impedance tomography 3 months
Primary Ventilation-perfusion matching (VQmatch) VQmatch will be assessed using electrical impedance tomography 3 months
Primary Global inhomogeneity index (VQmatch-GI) Within the defined VQmatch region assessed by electrical impedance tomography, the global inhomogeneity index (VQmatch-GI) was calculated to assess the degree of uniformity within the region. 3 months
Secondary Ventilation The ventilation of the lungs is assessed by electrical impedance tomography before and after prone positioning. 3 months
Secondary Perfusion The perfusion of the lungs is assessed by electrical impedance tomography before and after prone positioning. 3 months
Secondary Center of Ventilation (CoV) The center of ventilation of the lungs is assessed by electrical impedance tomography before and after prone positioning. 3 months
Secondary Standard deviation of regional ventilation delay The standard deviation of regional ventilation delay of the lungs is assessed by electrical impedance tomography before and after prone positioning. 3 months
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