The Value of Diaphragmatic Ultrasound in Non-invasive Oxygen Therapy

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

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.

Study Overview

• Status: Unknown
• Conditions: Intensive Care Unit; Diaphragm Ultrasound

Detailed Description

1. 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

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital
      • Contact: lixin xie, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): August 31, 2020

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2018TM-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No