NCT03250416

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,179

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

4.1 years

First QC Date

August 11, 2017

Last Update Submit

July 5, 2022

Conditions

Noninvasive Ventilation

Outcome Measures

Primary Outcomes (1)

  • Noninvasive ventilation failure

    Noninvasive ventilation failure was defined as requirement of intubation.

    From participation to 30 days

Secondary Outcomes (2)

  • Mortality

    From participation to 30 days

  • ICU stay

    From participation to 30 days

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital ,Chongqing Medical Univercity

Chongqing, Chongqing Municipality, 400016, China

Location

Study Officials

  • Jun Duan, Dr

    First Affiliated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 11, 2017

First Posted

August 15, 2017

Study Start

September 1, 2017

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

July 7, 2022

Record last verified: 2022-07

Locations

CN(1)