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

Recruiting

• Conditions: Respiratory Distress Syndrome, Adult; COVID-19
• Interventions: Drug: NO inhalation; Behavioral: prone postion

• Registration Number: NCT05715762
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2022-12
• Study Start: 2022-12-21
• Study First Submitted: 2023-01-28
• Study First Submitted QC: 2023-02-04
• Last Update Submitted: 2023-02-04
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• adult patients who have COVID-19-associated acute respiratory distress syndrome

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ventilation in supine position and NO inhalation	NO inhalation	Patients are ventilated in supine position with NO inhalation for 1 hour.
Ventilation in prone position for 1 hour	prone postion	Patients are ventilated in prone position for 1 hour.
Ventilation in prone position for 2 hours plus NO inhalation for 1 hour	prone postion	Patients are ventilated in prone position for 1 hour followed by ventilation in prone position with NO inhalation for 1 hour.
Ventilation in prone position for 2 hours plus NO inhalation for 1 hour	NO inhalation	Patients are ventilated in prone position for 1 hour followed by ventilation in prone position with NO inhalation for 1 hour.
Ventilation in prone position for 3 hours	prone postion	Patients are ventilated in prone position for 1 hour followed by ventilation in prone position with NO inhalation for 1 hour. Then they are ventilated in prone position alone for 1 hour.
Ventilation in prone position for 16 hours	prone postion	Patients are ventilated in prone position for 1 hour followed by ventilation in prone position with NO inhalation for 1 hour. Then they are ventilated in prone position alone for 14 hours.

Primary Outcome Measures

Name	Time	Method
oxygenation status	1 day	To evaluate the oxygenation parameters
regional distribution of pulmonary perfusion	1 day	To evaluate the effect of prone positon and NO inhalation on pulmonary blood flow distribution.
regional distribution of pulmonary ventilation	1 day	To evaluate the effect of prone positon and NO inhalation on pulmonary vetilation distribution.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China