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NCT05715762 Clinical Trial

Determine the Effects of Prone Positioning and NO in COVID-19 ARDS by EIT

COVID-19 Clinical Trial

Official title:
Determine the Effects of Prone Positioning and Nitric Oxide in Adult COVID-19 Patients With ARDS by Electrical Impedance Tomography

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05715762
Other study ID # eit20221221
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 21, 2022
Est. completion date December 31, 2023

Study information
Verified date December 2022
Source Shanghai Zhongshan Hospital
Contact Ming Zhong, PhD
Phone 021-65642662
Email zhong.ming@zs-hospital.sh.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

We aims to investigate the effects of prone positioning and nitric oxide inhalation in adult patients who is diagnosed with COVID-19 associated acute respiratory distress syndrome by electrical impedance tomography.

Description:

The investigators aim to investigate the effects of prone positioning and nitric oxide inhalation in adult patients who is diagnosed with COVID-19 associated acute respiratory distress syndrome by electrical impedance tomography (EIT). The EIT assessment is performed in patients ventilated in supine position, supine position with NO inhalation for 1 hour, prone position for 1 hour, prone position for 2 hours with NO inhalation for 1 hour, prone position for 3 hours, prone position for 16 hours, re-supine position for 3 hours. Arterial blood gas (ABG) analysis results, ventilator parameters and hemodynamic parameters are also recorded at each time point.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - adult patients who have COVID-19-associated acute respiratory distress syndrome Exclusion Criteria: - patients who refuse to participate in the study; unable to use EIT, such as open-chest surgery with chest tube placement; have contraindication for prone positioning, including pregnant, post-abdomen surgery within a week; hypercapnic respiratory failure.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• prone postion
ventilation at prone positioning
Drug:
• NO inhalation
NO inhalation at 20 ppm

Locations
Country Name City State
China Zhongshan Hospital, 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 oxygenation status To evaluate the oxygenation parameters 1 day
Primary regional distribution of pulmonary perfusion To evaluate the effect of prone positon and NO inhalation on pulmonary blood flow distribution. 1 day
Primary regional distribution of pulmonary ventilation To evaluate the effect of prone positon and NO inhalation on pulmonary vetilation distribution. 1 day
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