Clinical trial NCT03361683: Post-extubation High-flow Nasal Oxygen for Preventing Extubation Failure
Official title: Post-extubation High-flow Nasal Oxygen vs. Conventional Oxygen in Patients Recovered From Acute Hypoxemic Respiratory Failure for Preventing Extubation Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extubation Failure
Keywords: High-Flow nasal oxygen
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Intubated patients recovering from primary acute hypoxemic respiratory failure who have passed a spontaneous breathing trial will be included in the study. Following extubation, patients will be randomized assigned to one of two study groups. Heart rate, breathing rate, median arterial pressure, FiO2, SpO2, and dyspnea and comfort levels will be measured at defined intervals after extubation (basal, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, and 48 hours). An arterial blood gas test will be performed 60 minutes and 24 hours after extubation. The number of patients fulfilling certain preset criteria regarding extubation failure will be determined.

Extubation failure shall be defined as the need for using invasive mechanical ventilation again within two days following extubation based on the criteria below:

* Breathing rate over 25 breaths per minute for more than two hours.
* Heart rate above 140 beats per minute or with a sustained increase or decrease greater than 20%.
* Clinical data showing fatigue of the respiratory muscles or an increase in breathing work.
* SaO2 \<90%; PaO2 \<80 mmHg with a FiO2 \> 50%.
* Hypercapnia (PaCO2 \>45 mmHg or \>20% compared to the value before extubation) with a pH below 7.33.

Patients who do not fulfill the extubation failure criteria after the first 48 hours of admission may receive extra supplementary oxygen through any device (e.g., nasal cannula, face mask, reservoir mask, etc.). Every day, SpO2 will be measured and the moment when the patient reaches SpO2 \>94% with no need for oxygen will be determined.

Eligibility criteria: Inclusion Criteria:

Hypoxemic primary acute respiratory failure

Invasive mechanical ventilation for at least 48 hours

Successful Spontaneous Breathing Trial

Exclusion Criteria:

Immediate indication for invasive mechanical ventilation

Immediate indication for non-invasive mechanical ventilation

Self-extubation

One or more failed Spontaneous Breathing Trial

Chronic respiratory failure

Neuromuscular diseases

Tracheostomy.

Nasal cavity pathology

Facial surgery

Failure to authorize the informed consent

Primary outcomes:
measure: Post-extubation failure
timeFrame: First 48 hours
Secondary outcomes:
measure: PaO2/FiO2 Ratio Record.
timeFrame: Post-extubation period and up to 48 hours later.
measure: Determination of FiO2 Requirements.
timeFrame: Post-extubation period and up to 48 hours later.
measure: Respiratory Rate Record at Defined Intervals.
timeFrame: Post-extubation period and up to 48 hours later.
measure: Heart Rate Record at Defined Intervals.
timeFrame: Post-extubation period and up to 48 hours later.
measure: Mean Arterial Pressure Record at Defined Intervals.
timeFrame: Post-extubation period and up to 48 hours later.
measure: Treatment Comfort Assessment by means of a Visual Analogue Scale at Defined Intervals.
timeFrame: Post-extubation period and up to 48 hours later.
measure: Dyspnea Assessment by means of a Visual Analog Scale at Defined Intervals.
timeFrame: Post-extubation period and up to 48 hours later.
measure: Number of Days Requiring Oxygen after Successful Extubation
timeFrame: Post-extubation period and up to 14 days later.
measure: Number of Days Spent in the ICU after Extubation.
timeFrame: Post-extubation period and up to 28 days later.
measure: Days Spent in the Hospital After Extubation.
timeFrame: Post-extubation period and up to 28 days later
measure: Number of Deaths in the ICU after Extubation.
timeFrame: Post-extubation period and up to 28 days later
measure: Number of Deaths in the Hospital after Extubation.
timeFrame: Post extubation period and up to 28 days later.
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: National Institute of Medical Science and Nutrition Salvador Zubirán,
Study officials:
affiliation: National Institute of Medical Science and Nutrition Salvador Zubirán
name: Jose de Jesus Rodriguez-Andoney, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Hernandez G, Vaquero C, Gonzalez P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Conventional Oxygen Therapy on Reintubation in Low-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711.
citation: Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.