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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04725227
Other study ID # P-E
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date December 31, 2022

Study information

Verified date January 2021
Source Shanghai Zhongshan Hospital
Contact Ming Zhong, MD, phD
Phone 021-65642662
Email zhong.ming@zs-hospital.sh.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

determine the effect of prone positioning on ventilation and perfusion distribution in adults with acute respiratory distress syndrome by electrical impedance tomography


Description:

By intravenous injection of a small amount of normal saline, electrical impedance tomography enables evaluation of the pulmonary blood flow. EIT might be helpful in establishing the hypoxemia etiology at bedside via combining regional ventilation and perfusion information. The objective of this study was to describe the physiological effects of prone position on respiratory mechanics, ventilation and pulmonary perfusion in patients with ARDS.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - patients who were undergoing mechanical ventilation with moderate-to-severe ARDS (defined as a Pao2:Fio2 ratio < 150 mm Hg with a positive end-expiratory pressure = 5 cm of water, and an Fio2 of = 0.6) according to the Berlin definition Exclusion Criteria: - contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Zhongshan Hospital of Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assess regional distribution of pulmonary perfusion To evaluate the effect of prone positon on pulmonary blood flow distribution. within 24 hours
Primary Assess regional distribution of pulmonary ventilation To evaluate the effect of prone positon on pulmonary vetilation distribution. within 24 hours
Primary Assess oxygenation status To evaluate the effect of prone position by assessing regional distribution of pulmonary perfusion based on indicator dilution and changes at different points in time during varying states of regional ventilation will be evaluated. within 24 hours
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