Evaluating High-flow Nasal Cannula Oxygen Therapy Through LUS During Weaning

February 11, 2018 updated by: lu xiao

Evaluating High-flow Nasal Cannula Oxygen Therapy Through Lung Ultrasound Score

Respiratory distress after extubation is associated with increased morbidity and mortality. Its multifactorial pathophysiology causes a loss of pulmonary aeration during the weaning process, the clinical translation being impaired gas exchange and the occurrence of respiratory distress. Lung ultrasound can accurately quantify the loss of pulmonary aeration before, after end during the weaning trial by calculating the Lung Ultrasound Score (LUS). Investigators have recently demonstrated in a prospective two-center study of 100 patients that the intensity of the lung aeration loss occurring during the weaning trial, was predictive of the development of postextubation respiratory distress within 48 hours following extubation. A LUS ≥ 14 could identify patients at high risk of developing postextubation respiratory distress. A second study that investigators have just completed in 80 patients weaned from mechanical ventilation shows a 30% reduction of respiratory distress in post-extubation High Flow Nasal Cannula oxygen group compared to a standard O2 group.

The establishment of a targeted therapeutic strategy proposed in a group of high-risk patients, defined as having a ≥ 14 LUS at the end of the weaning trial could reduce the incidence of extubation failure and associated morbidity and mortality.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients above 18, mechanically ventilated on tracheal intubation for more than 48 hours.

Exclusion Criteria:

  • Patients with chronic obstructive pulmonary disease (COPD) with moderate to severe (3 and 4) stage defined by a forced expiratory volume in one second (FEV) <50% of theoretical value
  • Patients with previous chronic respiratory disease
  • Paraplegia with level> T8,
  • Severe ICU-acquired neuromyopathy
  • Patients with tracheostomy for any reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Conventional oxygen therapy
oxygen by a standard nasal cannula or nonrebreather mask
Device: Conventional oxygen therapy
oxygen by a standard nasal cannula or nonrebreather mask
ACTIVE_COMPARATOR: High-flow Nasal Cannula Oxygen Therapy
Device: high-flow nasal cannula oxygen
high-flow nasal cannula oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To decrease the incidence of extubation failure within 48 hours after a successful spontaneous breathing trial in ICU patients.
Time Frame: 48 hours
To decrease the incidence of extubation failure within 48 hours after a successful spontaneous breathing trial in ICU patients.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of ventilation-free days in ICU following the planned extubation after randomization. - Length of stay in ICU and in-hospital after randomization. - Mortality in ICU and at three months.
Time Frame: treatment in ICU and at three months.
Number of ventilation-free days and mortality in ICU and at three months.
treatment in ICU and at three months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

lu xiao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2018

Primary Completion (ANTICIPATED)

June 15, 2019

Study Completion (ANTICIPATED)

July 1, 2019

Study Registration Dates

First Submitted

May 1, 2017

First Submitted That Met QC Criteria

December 24, 2017

First Posted (ACTUAL)

December 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 11, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 214856056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on High-flow Nasal Cannula Oxygen

Clinical Trials on Conventional oxygen therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe