CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 127 enrolled
Drug / intervention
High-flow nasal oxygen +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03361683
NCT03361683N/ACompleted

Post-extubation High-flow Nasal Oxygen vs. Conventional Oxygen in Patients Recovered From Acute Hypoxemic Respiratory Failure for Preventing Extubation Failure

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·interventional·Posted Dec 5, 2017·Updated Aug 8, 2019

In Brief

A clinical study evaluating High-flow nasal oxygen and Venturi mask for Extubation Failure. Completed, enrolled 127 participants across 1 site.

Detailed Summary

Patients intubated due to acute respiratory failure have a high risk of infectious complications, airway injuries and multiple organic failure, so performing a successful extubation from mechanical ventilation is key. Between 10 and 20% of patients develop extubation failure, which is related to an increased in-hospital death rate, infections, higher costs and longer hospital stays. High-flow nasal oxygen therapy delivers heated, humidified air at flows up to 60L/min, and an oxygen concentration close to 100%, providing a fresh air reservoir at the naseo-pharyngeal level, evening out the peak inspiratory flow rate of the patient, improving air conductance, promoting secretion management, increasing end-expiratory lung volume, and applying a positive end-expiratory pressure. Such effects result in decreased breathing work, dyspnea relief, improved use tolerance, increased oxygenation, and lower fraction of inspired oxygen in patients with hypoxemic respiratory failure. High-flow oxygen therapy has recently been described to decrease extubation failure in a group of patients classified with low failure risk, in comparison to Venturi mask, and it was not inferior to non-invasive mechanical ventilation in high risk patients. However, it is worth pointing out that a large percentage of the patients included in such studies did not develop acute respiratory failure primarily. Given the beneficial effects described above, the investigators hypothesize that high-flow nasal oxygen therapy decreases the risk of extubation failure in a group of patients that required invasive mechanical ventilation due to primary acute hypoxemic respiratory failure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 5, 2017
Enrollment StartOct 1, 2017
Primary CompletionJun 30, 2019
Study CompletionJul 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.6 years ago

Interventions

High-flow nasal oxygendevice

Randomized patients will receive oxygen through a high nasal flow device capable of delivering humidified, heated air at an output rate of 40 L/min

Venturi maskdevice

Randomized patients will receive oxygen through a Venturi mask at an air flow of 15 L/min