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

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05715762

Collaborator

(none)

Enrollment

Location

12.3

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome, Adult COVID-19	Behavioral: prone postion Drug: NO inhalation

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 21, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Ventilation in supine position Patients are ventilated in supine position.
Ventilation in supine position and NO inhalation Patients are ventilated in supine position with NO inhalation for 1 hour.	Drug: NO inhalation NO inhalation at 20 ppm
Ventilation in prone position for 1 hour Patients are ventilated in prone position for 1 hour.	Behavioral: prone postion ventilation at prone positioning Other Names: PPV
Ventilation in prone position for 2 hours plus NO inhalation for 1 hour Patients are ventilated in prone position for 1 hour followed by ventilation in prone position with NO inhalation for 1 hour.	Behavioral: prone postion ventilation at prone positioning Other Names: PPV Drug: NO inhalation NO inhalation at 20 ppm
Ventilation in prone position for 3 hours 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.	Behavioral: prone postion ventilation at prone positioning Other Names: PPV
Ventilation in prone position for 16 hours 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.	Behavioral: prone postion ventilation at prone positioning Other Names: PPV
Ventilation in re-supine position for 3 hours Patients are ventilated in supine position for 3 hours followed by ventilation in prone position for 16 hours.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

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.