Non-Invasive Ventilation Versus High-flow Nasal Oxygen in Intensive Care Units

Condition(s) studied

Investigational drug(s) / intervention(s)

High-Flow Oxygen: Humidified and heated oxygen with a gas flow at least 50 L/min through nasal cannula

Non invasive ventilation: NIV will be carried out in pressure-support mode with a minimal pressure-support level of 5 cmH2O targeting a tidal volume around 6 to 8 mL/kg of predicted bodyweight, a positive end-expiratory pressure (PEEP) level at least 8 cm H2O, and FiO2 adjusted to obtain adequate oxygenation

Study summary

In intensive care units (ICUs), around 20% of patients experience respiratory failure after planned extubation. Nearly 40-50% of them eventually require reintubation with subsequently high mortality rates reaching 30-40%. NIV used as rescue therapy to treat post-extubation respiratory failure could increase the risk of death. However, NIV may avoid reintubation in a number of cases, and recent large-scale clinical trials on extubation have shown that around 40 to 50% of patients with post-extubation respiratory failure are actually treated with NIV. Whereas high-flow nasal oxygen has never been specifically studied for management of post-extubation respiratory failure, this respiratory support could also in this setting constitute an alternative to standard oxygen or NIV. Given the best noninvasive respiratory support strategy in patients with post-extubation respiratory failure remains unknown, we have decided to assess whether NIV alternating with high-flow nasal oxygen as compared to high-flow nasal oxygen alone may decrease mortality of patients in ICUs with post-extubation respiratory failure.

Eligibility

Primary outcome measure(s)

• Mortality at 28 days after post-extubation respiratory failure — Day 28
  Death between post-extubation respiratory failure and 28 days after post-extubation respiratory failure

Trial sites (47)

+ 7 more sites — see the full list on the official registry below.

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