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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02739451
• Date of registration: 29/03/2016
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: A Randomised Controlled Trial of High-Flow Nasal Oxygen Versus Standard Oxygen Therapy in Critically Ill Immunocompromised Patients HIGH
• Scientific title: A Randomised Controlled Trial of High-Flow Nasal Oxygen Versus Standard Oxygen Therapy in Critically Ill Immunocompromised Patients
• Date of first enrolment: May 2016
• Target sample size: 776
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02739451
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Elie Azoulay, MDPhD
• Affiliation: APHP

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acute Respiratory Failure

Intervention(s)

Procedure: standard oxygen

Procedure: HFNO

Primary Outcome(s)

All-cause day-28 mortality [Time Frame: 28 days]

Secondary Outcome(s)

Perceived Exertion [Time Frame: days 1-3]

patient comfort [Time Frame: 28 days]

Respiratory rate [Time Frame: days 1-3]

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]

Hypoxemic cardiac arrests [Time Frame: day 28]

Intubation or reintubation rate [Time Frame: days 3 and 28]

ICU length of stay [Time Frame: 28 days]

Intensity of dyspnoea [Time Frame: days 1-3]

Time to clear pulmonary infiltrates [Time Frame: 28 days]

Oxygen-free and ventilation-free survivals [Time Frame: day 28]

Incidence of ICU-acquired infections [Time Frame: 28 days]

Lowest median SpO2 during intubation [Time Frame: days 1-3]

Oxygenation [Time Frame: days 1-3]

Re-intubation rate [Time Frame: day 28]

Secondary ID(s)

AOM15003

P150912

Source(s) of Monetary Support

Please refer to primary and secondary sponsors