NCT05715788

Brief Summary

The investigators aim to investigate the effects of prone positioning and prone positioning with NO inhalation for COVID-19 patients with ARDS.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

February 4, 2023

Last Update Submit

February 4, 2023

Conditions

Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • P/F ratio

    P/F ratios in each group

    16 hours

Study Arms (2)

patients ventilated in prone position

Patients ventilated in prone position

Behavioral: prone positioning

Patients ventilated in prone position with NO inhalation

Patients ventilated in prone position with NO inhalation

Drug: Nitric oxideBehavioral: prone positioning

Interventions

Nitric oxideDRUG

Nitric oxide inhalation at 20 ppm

Patients ventilated in prone position with NO inhalation
prone positioningBEHAVIORAL

vatilation in prone position

Also known as: PPV
Patients ventilated in prone position with NO inhalationpatients ventilated in prone position

Eligibility Criteria

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

Patients with COVID-19 associated ARDS

You may qualify if:

  • Adult patients with COVID-19 associated ARDS

You may not qualify if:

  • patients who 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 Syndrome

Interventions

Nitric OxideProne Position

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Reactive Nitrogen SpeciesFree RadicalsInorganic ChemicalsNitrogen OxidesNitrogen CompoundsOxidesOxygen CompoundsOrganic ChemicalsPostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ming Zhong, PhD

    Fudan University

    STUDY CHAIR

Central Study Contacts

Ming Zhong, PhD

CONTACT

‭(021) 6564 2662‬zhong.ming@zs-hospital.sh.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2023

First Posted

February 8, 2023

Study Start

December 21, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)