NCT04355559

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.

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Typical duration 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

August 1, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

1.7 years

First QC Date

March 24, 2020

Last Update Submit

April 20, 2020

Conditions

Diaphragm UltrasoundIntensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Arterial blood gas analysis results

    When the intervention which is the first time to change the oxygen therapy

Study Arms (3)

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

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Central Study Contacts

ruoxuan wen, Respiratory therapist

CONTACT

15801216687905508797@qq.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 24, 2020

First Posted

April 21, 2020

Study Start

August 1, 2018

Primary Completion

April 30, 2020

Study Completion

August 31, 2020

Last Updated

April 21, 2020

Record last verified: 2020-04

Locations

CN(1)