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

NCT02739451 | Completed DMC

• 2 other identifiers: AOM15003P150912
• Study Type: interventional
• Target: 776
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

immunocompromized patients; critically ill patients

Outcome Measures

Primary Outcomes (1)

• All-cause day-28 mortality

  28 days

Secondary Outcomes (14)

• Intubation or reintubation rate

  days 3 and 28

• patient comfort

  28 days

• Intensity of dyspnoea

  days 1-3

• Perceived Exertion

  days 1-3

• Respiratory rate

  days 1-3

Study Arms (2)

standard oxygen group

ACTIVE COMPARATOR

Oxygen therapy will be delivered using any device or combination of devices that are part of usual care: nasal oxygen, and mask with or without a reservoir bag and with or without the Venturi system

Procedure: standard oxygen

High-flow nasal oxygen (HFNO) group

EXPERIMENTAL

Device that delivers humidified and warmed high-flow oxygen at flows greater than 15 L/min. HFNO will be initiated at a flow rate of 50 L/min and 100% FiO2. If the target SpO2 is not reached, the flow rate will be increased to 60 L/min. Then, FiO2 will be tapered to target an SpO2≥95. The minimal flow rate will be 45 L/min

Procedure: HFNO

Interventions

standard oxygen PROCEDURE

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 \[Venturi masks and medium-flow facemasks\]

standard oxygen group

HFNO PROCEDURE

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).

High-flow nasal oxygen (HFNO) group

Eligibility Criteria

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

You may qualify if:

• Known immunosuppression defined as one or more of the following: (a) immunosuppressive drug or long-term \[\>3 months\] or high-dose \[\>0.5 mg/kg/day\] steroids; (b) solid organ transplantation; (c) solid tumour; (d) haematological malignancy.
• ICU admission for any reason
• Need for oxygen therapy ≥6 Liters/min defined as one or more of the following: (a) respiratory distress with a respiratory rate \>30/min; (b) cyanosis; (c) laboured breathing; (d) SpO2\<90%; and (e) expected respiratory deterioration during a procedure

You may not qualify if:

• Patient admitted to the ICU for end-of-life care. Do-not-intubate (DNI) patients can be included.
• Refusal of study participation or to pursue the study by the patient
• Hypercapnia with a formal indication for NIV \[PaCO2 ≥ 50 mmHg, formal indication for NIV\]
• Isolated cardiogenic pulmonary oedema \[formal indication for NIV\]. Patients with pulmonary oedema associated with another ARF etiology can be included.
• Pregnancy or breastfeeding
• Anatomical factors precluding the use of a nasal cannula
• Absence of coverage by the French statutory healthcare insurance system
• Post surgical setting from D1 to D6
• After discussion at the investigator meeting and based on comments from the Data and Safety Monitoring Board on May 12, 2016, as all included patients need to have an acute hypoxemic respiratory failure and at least 6l of oxygen per minute, patients admitted to the ICU to secure any procedure (bronchoscopy etc..) or those not admitted for acute respiratory failure and who undergo intubation, will NOT be included in this trial. Only patients meeting criteria of acute respiratory failure will be included in this trial.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Medical ICU

Paris, 75010, France

Location

Related Publications (2)

• Azoulay E, Lemiale V, Mokart D, Nseir S, Argaud L, Pene F, Kontar L, Bruneel F, Klouche K, Barbier F, Reignier J, Berrahil-Meksen L, Louis G, Constantin JM, Mayaux J, Wallet F, Kouatchet A, Peigne V, Theodose I, Perez P, Girault C, Jaber S, Oziel J, Nyunga M, Terzi N, Bouadma L, Lebert C, Lautrette A, Bige N, Raphalen JH, Papazian L, Darmon M, Chevret S, Demoule A. Effect of High-Flow Nasal Oxygen vs Standard Oxygen on 28-Day Mortality in Immunocompromised Patients With Acute Respiratory Failure: The HIGH Randomized Clinical Trial. JAMA. 2018 Nov 27;320(20):2099-2107. doi: 10.1001/jama.2018.14282.

  PMID: 30357270 DERIVED

• Azoulay E, Lemiale V, Mokart D, Nseir S, Argaud L, Pene F, Kontar L, Bruneel F, Klouche K, Barbier F, Reignier J, Stoclin A, Louis G, Constantin JM, Mayaux J, Wallet F, Kouatchet A, Peigne V, Perez P, Girault C, Jaber S, Oziel J, Nyunga M, Terzi N, Bouadma L, Lebert C, Lautrette A, Bige N, Raphalen JH, Papazian L, Rabbat A, Darmon M, Chevret S, Demoule A. High-flow nasal oxygen vs. standard oxygen therapy in immunocompromised patients with acute respiratory failure: study protocol for a randomized controlled trial. Trials. 2018 Mar 5;19(1):157. doi: 10.1186/s13063-018-2492-z.

  PMID: 29506579 DERIVED

Study Officials

• Elie Azoulay, MDPhD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 15, 2016
• Study Start: May 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: July 24, 2018

Record last verified: 2018-07

Locations

FR (1)