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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Respiratory Distress Syndrome, Adult
• Intervention / Treatment: Drug: NO inhalation; Behavioral: prone postion

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Ming Zhong, PhD; Phone Number: 021-65642662; Email: zhong.ming@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Ming Zhong, phD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	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.	Drug: NO inhalation; NO inhalation at 20 ppm; Behavioral: prone postion; ventilation at prone positioning; Other Names: PPV
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Chair: Ming Zhong, PhD, Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 21, 2022
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: January 28, 2023
• First Submitted That Met QC Criteria: February 4, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 4, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Respiratory Distress Syndrome
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: eit20221221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No