Effectiveness of High Flow Oxygen Therapy in Patients With Hematologic Malignancy Acute Hypoxemic Respiratory Failure

Study Overview
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Brief Summary
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Effectiveness of high flow oxygen therapy in patients with hematologic malignancy acute hypoxemic respiratory failure

Detailed Description
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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 to achieve SpO2≥95%. 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 dyspnea and discomfort, decreases in tachypnea 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, minimizing the need for endotracheal intubation

Official Title
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Effectiveness of High Flow Oxygen Therapy in Patients With Hematologic Malignancy Acute Hypoxemic Respiratory Failure

Conditions
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Acute Hypoxemic Respiratory Failure, Hematologic Malignancy

Intervention / Treatment
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* Device: High flow oxygen therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known immunosuppression defined as haematological malignancy. Need for oxygen therapy defined as with oxygen free arterial blood gas examination one or more of the following: (a) PaO2/FiO2<300 mmHg (b) PaCO2≤45 mmHg (c) SaO2<92% Respiratory distress with a respiratory rate >22/min Exclusion Criteria: Refusal of study participation Pregnancy or breastfeeding Hypercapnia with a formal indication for non-invasive mechanical ventilation (NIMV) (PaCO2 ≥ 45 mmHg) Patients whose clinicians have decided on NIMV (Non-Invasive Mechanical Ventilation) and IMV (Invasive Mechanical Ventilation) Haemodynamic instability (mean arterial pressure <65 mmHg) Vasopressor needs Awareness confusion and disorientation

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 |
| --- | --- |
| No Intervention: Standard oxygen group<br>This patient groups will receive only routine oxygen therapy. Routine oxygen therapy involves administering low-to-medium oxygen flows through a nasal cannula or mask to achieve SpO2≥95%. | |
| Experimental: High flow oxygen therapy group<br>This patients group will receive high flow oxygen therapy. High flow nasal oxygen therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, it 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%. | Device: High flow oxygen therapy<br>* 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%.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation rate | Intubation rate for each group | First seven days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | All-cause day-28 mortality | First 28 days | 
| patients comforts | Patient comfort with Visual Analogue Scale (VAS) score | First 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory failure, immuncompromise patients, high flow oxygen