Management of Noninvasive Ventilation in Hypoxemic Patients | NCT03250416

Studies
Management of Noninvasive Ventilation in Hypoxemic Patients

NCT03250416

Sponsor

Chongqing Medical University

Status

Completed

Last Update Posted

Jul 7, 2022Actual

Enrollment

2,179Actual

Phase

Not provided

Conditions

Noninvasive Ventilation

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

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Sep 30, 2021Actual

Completion Date

Sep 30, 2021Actual

First Submitted Date

Aug 11, 2017

First Submission Date that Met QC Criteria

Aug 14, 2017

First Posted Date

Aug 15, 2017Actual

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

Jul 5, 2022

Last Update Posted Date

Jul 7, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 investigator aimed to manage noninvasive ventilation in patients with hypoxemic respiratory failure.

Detailed Description

Patients with hypoxemic respiratory failure were enrolled in this study. The investigator collected the data at beginning and first stage of noninvasive ventilation to analyze the efficacy of noninvasive ventilation. To manage the noninvasive ventilation easily, the investigator also aimed to develop a scale to predict the efficacy of noninvasive ventilation, and used this scale to guide clinicians how to use noninvasive ventilation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,179Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Noninvasive ventilation failure	Noninvasive ventilation failure was defined as requirement of intubation.	From participation to 30 days

Secondary Outcomes

Measure	Description	Time Frame
Mortality	Mortality in ICU and hospital	From participation to 30 days
ICU stay	Length of ICU stay	From participation to 30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

PaO2/FiO2 less than 300; PaCO2 less than 50 mmHg; Respiratory rate more than 25 breaths/min or presence of labored breath.

Exclusion Criteria:

Requirement of emergency intubation; Sequential use of noninvasive ventilation after extubation;Use of noninvasive ventilation after accident extubation.

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

The main population is acute hypoxemic respiratory failure. The subgroup included ARDS, pneumonia, sepsis and so on.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jun Duan, Dr	First Affiliated Hospital of Chongqing Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital ,Chongqing Medical Univercity		Chongqing	Chongqing Municipality	400016	China