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A Randomised Controlled Trial of High-Flow Nasal Oxygen Versus Standard Oxygen Therapy in Critically Ill Immunocompromised Patients

NCT02739451 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 776

Last updated 2018-07-24

No results posted yet for this study

Summary

Acute respiratory failure (ARF) is the leading reason for ICU admission in immunocompromised patients. Usual oxygen therapy involves administering low-to-medium oxygen flows through a nasal cannula or mask \[with or without a bag and with or without the Venturi system\] to achieve SpO2≥95%.

Oxygen therapy may be combined with non-invasive ventilation \[NIV\] providing both end-expiratory positive pressure and pressure support. However, in a recent trial by our group, non-invasive ventialtion \[NIV\] was not superior over oxygen without NIV.

High-flow nasal oxygen \[HFNO\] therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates \[of up to 60 L/min\] via nasal cannula devices, with Fraction of inspired oxygen (FiO2) values of nearly 100%. Physiological benefits of HFNO consist of higher and constant FiO2 values, decreased work of breathing, nasopharyngeal washout leading to improved breathing-effort efficiency, and higher positive airway pressures associated with better lung recruitment.

Clinical consequences of these physiological benefits include alleviation of dyspnoea and discomfort, decreases in tachypnoea and signs of respiratory distress, a diminished need for intubation in patients with severe hypoxemia, and decreased mortality in unselected patients with acute hypoxemic respiratory failure However, although preliminary data establish the feasibility and safety of this technique, HFNO has never been properly evaluated in immunocompromised patients.

Thus, this project aims at demonstrating that HFNO is superior to low/medium-flow (standard) oxygen, minimising day-28 mortality

Conditions

  • Acute Respiratory Failure

Interventions

PROCEDURE

standard oxygen

Devices used to treat spontaneously ventilating patients in the ICU who require supplemental oxygen. They deliver either * low-flow oxygen \[including nasal cannula, Ventimask® without Venturi effect, and non-rebreather mask\] * or medium-flow oxygen \[Venturi masks and medium-flow facemasks\]

PROCEDURE

HFNO

The intervention is the use of a device that allows to deliver high flow humidified and warmed oxygen. The device used is the Optiflow™ (Fisher\&Paykel, Courtaboeuf, France).

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Elie Azoulay, MDPhD · APHP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02739451 on ClinicalTrials.gov