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

NCT03384394 | Unknown

• 1 other identifier: 214856056
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

High-flow Nasal Cannula Oxygen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Conventional oxygen therapy

PLACEBO COMPARATOR

oxygen by a standard nasal cannula or nonrebreather mask

Device: Conventional oxygen therapy

High-flow Nasal Cannula Oxygen Therapy

ACTIVE COMPARATOR

High-flow Nasal Cannula Oxygen Therapy

Device: high-flow nasal cannula oxygen

Interventions

high-flow nasal cannula oxygen DEVICE

high-flow nasal cannula oxygen

High-flow Nasal Cannula Oxygen Therapy

Conventional oxygen therapy DEVICE

oxygen by a standard nasal cannula or nonrebreather mask

Conventional oxygen therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• lu xiao: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator,Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: December 27, 2017
• Study Start: March 1, 2018
• Primary Completion: June 15, 2019
• Study Completion: July 1, 2019
• Last Updated: February 13, 2018

Record last verified: 2018-02