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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03384394
Enrollment
250
Registered
2017-12-27
Start date
2018-03-01
Completion date
2019-07-01
Last updated
2018-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-flow Nasal Cannula Oxygen

Brief 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.

Interventions

high-flow nasal cannula oxygen

oxygen by a standard nasal cannula or nonrebreather mask

Sponsors

lu xiao
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
To decrease the incidence of extubation failure within 48 hours after a successful spontaneous breathing trial in ICU patients.48 hoursTo decrease the incidence of extubation failure within 48 hours after a successful spontaneous breathing trial in ICU patients.

Secondary

MeasureTime frameDescription
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.treatment in ICU and at three months.Number of ventilation-free days and mortality in ICU and at three months.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026