NCT05715762

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 28, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 8, 2023

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

January 28, 2023

Last Update Submit

February 4, 2023

Conditions

Respiratory Distress Syndrome, AdultCOVID-19

Keywords

Respiratory Distress SyndromeCOVID-19

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (7)

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

Ventilation in prone position for 1 hour

Patients are ventilated in prone position for 1 hour.

Behavioral: prone postion

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 postionDrug: NO inhalation

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 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 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.

Interventions

prone postionBEHAVIORAL

ventilation at prone positioning

Also known as: PPV
Ventilation in prone position for 1 hourVentilation in prone position for 16 hoursVentilation in prone position for 2 hours plus NO inhalation for 1 hourVentilation in prone position for 3 hours
NO inhalationDRUG

NO inhalation at 20 ppm

Ventilation in prone position for 2 hours plus NO inhalation for 1 hourVentilation in supine position and NO inhalation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Study Officials

  • Ming Zhong, PhD

    Fudan University

    STUDY CHAIR

Central Study Contacts

Ming Zhong, PhD

CONTACT

021-65642662zhong.ming@zs-hospital.sh.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2023

First Posted

February 8, 2023

Study Start

December 21, 2022

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

February 8, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)