Prone Positioning vs. Prone Positioning and NO Inhalation... | NCT05715788

Studies
Prone Positioning vs. Prone Positioning and NO Inhalation in COVID-19 ARDS.

NCT05715788

Sponsor

Shanghai Zhongshan Hospital

Status

Unknown status

Last Update Posted

Feb 8, 2023Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Respiratory Distress Syndrome

Interventions

Nitric oxide
prone positioning

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 21, 2022Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Feb 4, 2023

First Submission Date that Met QC Criteria

Feb 4, 2023

First Posted Date

Feb 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2023

Last Update Posted Date

Feb 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

The investigators aim to investigate the effects of prone positioning and prone positioning with NO inhalation for COVID-19 patients with ARDS. Patients with COVID-19-associated ARDS were ventilated in prone position with or without NO inhalation, the arterial blood gas (ABG) tests were performed at 16 hours after prone positioning.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 oxide Behavioral: prone positioning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nitric oxide	Drug	Nitric oxide inhalation at 20 ppm	Patients ventilated in prone position with NO inhalation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
P/F ratio	P/F ratios in each group	16 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients with COVID-19 associated ARDS

Exclusion Criteria:

patients who have contraindication for prone positioning, including pregnant, post-abdomen surgery within a week; hypercapnic respiratory failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with COVID-19 associated ARDS

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ming Zhong, PhD	Contact	‭(021) 6564 2662‬		zhong.ming@zs-hospital.sh.cn

Overall Officials

Name	Affiliation	Role
Ming Zhong, PhD	Fudan University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Hospital, Fudan University	Recruiting	Shanghai	Shanghai Municipality	200032	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009569	Nitric Oxide
D016684	Prone Position

Ancestor Terms

ID	Term
D026361	Reactive Nitrogen Species
D005609	Free Radicals
D007287	Inorganic Chemicals
D009589	Nitrogen Oxides

Browse Leaves

Not provided

Browse Branches

Not provided