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

High-flow Nasal Cannula Oxygen Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03384394
• Other study ID #: 214856056
• Status: Not yet recruiting
• Phase: N/A
• First received: May 1, 2017
• Last updated: February 11, 2018
• Start date: March 1, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: February 2018
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: July 1, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• High-flow Nasal Cannula Oxygen

Intervention

Device:
• high-flow nasal cannula oxygen
high-flow nasal cannula oxygen
• Conventional oxygen therapy
oxygen by a standard nasal cannula or nonrebreather mask

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
lu xiao

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To decrease the incidence of extubation failure within 48 hours after a successful spontaneous breathing trial in ICU patients.	To decrease the incidence of extubation failure within 48 hours after a successful spontaneous breathing trial in ICU patients.	48 hours
Secondary	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.	Number of ventilation-free days and mortality in ICU and at three months.	treatment in ICU and at three months.