Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients

Study Overview
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Brief Summary
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In immunocompromised patients, Acute Respiratory Failure (ARF) is associated with a high case-fatality, particularly when invasive Mechanical Ventilation (MV) is required. In the most hypoxemic patients, oxygen administration through High Flow Nasal Cannula (HFNC) has been reported as an alternative to the venturi mask. The aim of this study is to compare HFNC and venturi mask on early respiratory deterioration and patient's comfort in that setting. The investigators planned a prospective randomized study in 4 Intensive Care Units (ICUs). As respiratory deterioration occurs early after ICU admission, patients are randomized to receive two hours of oxygen therapy either through HFNC or venturi mask. The primary endpoint is defined as the need for invasive or noninvasive MV in the 2-hour period. Secondary endpoints include comfort, dyspnea and thirst.

Official Title
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Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients

Conditions
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Acute Respiratory Failure, Immunocompromised Host, High Flow Oxygen Cannula

Intervention / Treatment
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* Device: High Flow Nasal Canula (HFNC)
* Device: Venturi mask
* Drug: Oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years. Admission to ICU for ARF. ARF was defined with the need of oxygen over 6l/min to maintain SpO2 over 95% or symptom of respiratory distress (intercostal recession or tachypnea >30/min or dyspnea at rest). Immunosuppression. Immunosuppressed conditions were solid tumor, hematological malignancy, steroid treatment or other immunosuppressive treatment, or HIV infection. Exclusion Criteria: Hypercapnia (above 47 mmHg) Chronic respiratory failure Previous mechanical ventilation in the days before admission Need of immediate NIV or intubation Refusal Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Venturi group<br>Venturi group : Oxygen is delivered using oxygen Venturi mask FiO2 is started at 60% (15l/min) and modified to maintain SpO2 over 94%. | Device: Venturi mask<br> <br> Drug: Oxygen<br> <br> |
| Experimental: HFNC group<br>HFNC group : Oxygen is delivered using HFNC. HFNC is started with FIO2 =1 and modified to maintain SpO2 over 94%, flow is settled at 40-50l/min. | Device: High Flow Nasal Canula (HFNC)<br> <br> Drug: Oxygen<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation failure | Oxygenation failure is defined with the need of invasive Mechanical Ventilation or Non invasive ventilation during the two hours study period | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comfort (0-10 Visual analog Scale) | 0-10 Visual analog Scale | 1 hour | 
| comfort (0-10 Visual analog Scale) | 0-10 Visual analog Scale | 2 hours | 
| dyspnea (0-10 Visual analog Scale) | 0-10 Visual analog Scale | 1 hour | 
| dyspnea (0-10 Visual analog Scale) | 0-10 Visual analog Scale | 2 hour | 
| thirst (0-10 Visual analog Scale) | 0-10 Visual analog Scale | 1 hour | 
| thirst (0-10 Visual analog Scale) | 0-10 Visual analog Scale | 2 hour |