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

NCT ID: NCT05715762

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-21

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Respiratory Distress Syndrome, Adult COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ventilation in supine position

Patients are ventilated in supine position.

No interventions assigned to this group

Ventilation in supine position and NO inhalation

Patients are ventilated in supine position with NO inhalation for 1 hour.

NO inhalation

Intervention Type DRUG

NO inhalation at 20 ppm

Ventilation in prone position for 1 hour

Patients are ventilated in prone position for 1 hour.

prone postion

Intervention Type BEHAVIORAL

ventilation at prone positioning

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.

prone postion

Intervention Type BEHAVIORAL

ventilation at prone positioning

NO inhalation

Intervention Type DRUG

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.

prone postion

Intervention Type BEHAVIORAL

ventilation at prone positioning

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.

prone postion

Intervention Type BEHAVIORAL

ventilation at prone positioning

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.

No interventions assigned to this group

Interventions

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prone postion

ventilation at prone positioning

Intervention Type BEHAVIORAL

NO inhalation

NO inhalation at 20 ppm

Intervention Type DRUG

Other Intervention Names

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PPV

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ming Zhong, PhD

Role: STUDY_CHAIR

Fudan University

Locations

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Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ming Zhong, PhD

Role: CONTACT

021-65642662

Facility Contacts

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Ming Zhong, PhD

Role: primary

Other Identifiers

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eit20221221

Identifier Type: -

Identifier Source: org_study_id

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