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NCT Number: NCT02739451

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

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

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Key information

Conditions

Acute Respiratory Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical ICU

Paris, 75010, France

About this study

After discussion at the investigator meeting and based on comments from the Data and Safety Monitoring Board on May 12, 2016, the DSMB has highlighted the need of the interim analysis (already planned) as benefits from high flow oxygen may be observed after 400 inclusions.

Update on June 16, 2017:

The number of patients enrolled is 488 and the inclusion rate is increasing steadily.

The interim analysis has been performed as scheduled and the DSMB decided that nothing should be changed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.

Exclusion criteria

  • 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.

Treatment and study plan

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]

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).

Primary outcomes

  1. All-cause day-28 mortality

    Time frame: 28 days

Secondary outcomes

  1. Intubation or reintubation rate

    Time frame: days 3 and 28

    proportion of patients requiring invasive mechanical ventilation

  2. patient comfort

    Time frame: 28 days

    Visual Analogue Scale (VAS) score

  3. Intensity of dyspnoea

    Time frame: days 1-3

    Visual Analogue Scale (VAS) score

  4. Perceived Exertion

    Time frame: days 1-3

    Borg scale

  5. Respiratory rate

    Time frame: days 1-3

  6. Oxygenation

    Time frame: days 1-3

    based on continuous saturation of peripheral oxygen (SpO2) monitoring, lowest SpO2 from D1 to D3 and PaO2/FiO2 on D1, D2, and D3

  7. ICU length of stay

    Time frame: 28 days

  8. Incidence of ICU-acquired infections

    Time frame: 28 days

  9. Time to clear pulmonary infiltrates

    Time frame: 28 days

    Murray score

  10. Oxygen-free and ventilation-free survivals

    Time frame: day 28

  11. Re-intubation rate

    Time frame: day 28

  12. Lowest median SpO2 during intubation

    Time frame: days 1-3

    for patients who were intubated during the study period

  13. Repartition of acute mild/moderate/severe respiratory distress syndrome (ARDS) stages after intubation or reintubation as defined by the Berlin definition

    Time frame: day 28

  14. Hypoxemic cardiac arrests

    Time frame: day 28

    After discussion at the investigator meeting and based on comments from the Data and Safety Monitoring Board on May 12, 2016, all hypoxemic cardiac arrests will be considered as suspected unexpected serious adverse reaction

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: HIGH

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 15, 2016
Registry last updated
Jul 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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