The Value of Diaphragmatic Ultrasound in Non-invasive Oxy... | NCT04355559

Studies
The Value of Diaphragmatic Ultrasound in Non-invasive Oxygen Therapy

NCT04355559

Sponsor

Chinese PLA General Hospital

Status

Unknown status

Last Update Posted

Apr 21, 2020Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Diaphragm Ultrasound
Intensive Care Unit

Interventions

Not provided

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

Apr 2020

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

Aug 1, 2018Actual

Primary Completion Date

Apr 30, 2020Estimated

Completion Date

Aug 31, 2020Estimated

First Submitted Date

Mar 24, 2020

First Submission Date that Met QC Criteria

Apr 20, 2020

First Posted Date

Apr 21, 2020Actual

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

Apr 20, 2020

Last Update Posted Date

Apr 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

In this study, a single-center, prospective, observational study was adopted to set the cut-off values of diaphragmatic ultrasound results and arterial blood gas results，with the choice of non-invasive oxygen therapy as the gold standard,so as to evaluate the diagnostic value of diaphragmatic ultrasound in the selection of non-invasive oxygen therapy.

Detailed Description

the cut-off values of diaphragmatic ultrasound results and arterial blood gas results were established by the selection results of non-invasive oxygen therapy of 120 patients in the intensive care unit and using receiver operating Characteristic curve.

diaphragm excursion，inspiratory time，diaphragm contraction velocity，diaphragm excursion time

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

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
conventional oxygen therapy		Continuous use of current oxygen therapy
high flow nasal cannula		change the oxygen therapy to high flow nasal cannula
Noninvasive ventilation		change the oxygen therapy to noninvasive ventilation

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the data diaphragmatic ultrasound	Record the data at the baseline and intervention	When the intervention which is the first time to change the oxygen therapy

Secondary Outcomes

Measure	Description	Time Frame
Arterial blood gas analysis results	Record the data at the baseline and intervention	When the intervention which is the first time to change the oxygen therapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients older than 18 years
without Invasive mechanical ventilation when entering the intensive care unit.

Exclusion Criteria:

have noninvasive ventilation or high flow nasal cannula contraindications
history of neuromuscular disease chest wall deformities
previously assessed diaphragmatic palsy
shock or severe hemodynamic instability
known pregnancy, and/or need for immediate endotracheal intubation

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 older than 18 years without Invasive mechanical ventilation when entering the intensive care unit.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ruoxuan wen, Respiratory therapist	Contact	15801216687		905508797@qq.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital	Recruiting	Beijing	Beijing Municipality	100853	China