Comparison of High-flow Oxygen vs. BiPAP in Type II (Hypercapnic) Respiratory Failure

Study Overview
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Brief Summary
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A retrospective cohort study of all patients treated for type II (hypercapnic) respiratory failure with either High-Flow Oxygen Therapy or Non-Invasive Ventilation in a general adult hospital.

Detailed Description
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We will compare various clinically relevant outcomes in patients treated for type II (hypercapnic) acute respiratory failure (ARF) with either High-Flow Nasal Cannula (HFNC) or Non-Invasive Ventilation (NIV) in a general adult hospital. All patients treated with HFNC were treated with an Optiflow device (Fisher&Paykel). Various Bilevel positive airway pressure (BiPAP) devices were used during the study period. All ventilatory parameters were set according to the treating physicians' preferences.

Official Title
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Retrospective Cohort Study of Patients With Type II (Hypercapnic) Respiratory Failure Treated With High-flow Oxygen Therapy Versus Non-invasive Ventilation With BiPAP

Conditions
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COPD, Respiratory Failure, Respiratory Insufficiency, Respiratory Tract Diseases, COPD Exacerbation, Pneumonia, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: Non-Invasive Ventilation
* Device: High-Flow Nasal Cannula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients treated with respiratory failure not responding to conventional supplemental oxygen therapy Blood venous gas showing partial pressure of carbon dioxide>50 mmHg before beginning therapy with either NIV or HFNC Exclusion Criteria: Lack of records of the primary outcome End-of-life care Lack of gas before the beginning of NIV or HFNC

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with type II ARF<br>All patients with type II respiratory failure that were deemed by the treating physician to require ventilatory support either with non-invasive ventilation (NIV) or High-Flow Nasal Cannula (HFNC). | Device: Non-Invasive Ventilation<br>* Treatment with Non-Invasive Ventilation by BiPAP. Different BiPAP models are in use. Ventilation parameters set at the discretion of the treating physician.<br>* Other names: BiPAP;Device: High-Flow Nasal Cannula<br>* Treatment with a High-Flow Nasal Cannula. The Optiflow device by Fisher&Paykel used in all cases. Flow and fraction of inspired oxygen (FiO2) parameters at the discretion of the treating physician.<br>* Other names: HFNC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure of initial treatment (combined outcome) | Combined outcome of death or intubation or transition to another treatment modality or unplanned resumption of respiratory support | 48 hours post intervention | 
| Death at 48h | Mortality in the 48h following the initial intervention | 48 hours post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at 7d | Incidence of death in the 7 days after intervention | 7 days post intervention | 
| Incidence of endotracheal intubation | The incidence of intubation | For the whole length of hospital stay, up to a maximum of one year. | 
| Length of stay | Duration of stay in the hospital, in days | For the whole length of hospital stay, up to a maximum of one year. | 
| Duration of endotracheal intubation | Duration (in hours) of the first episode of endotracheal intubation, immediately following the failed intervention | For the whole length of hospital stay, up to a maximum of one year. | 
| Incidence of intervention change | The incidence of patients who switch from Non-Invasive Ventilation to High-Flow Oxygen, and vice versa, due to treatment failure | For the whole length of hospital stay, up to a maximum of one year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic obstructive Pulmonary Disease, Non invasive ventilation, BiPAP, High-Flow Oxygen Therapy, High-Flow Nasal Cannula, COPD, Hypercapnia, Hypercapnic Respiratory failure