High Flow Oxygen and Non Invasive Ventilation for Hypercapnic Respiratory Failure

Study Overview
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Brief Summary
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this study evaluates high flow oxygen therapy in addition to non invasive ventilation (NIV) to treat hypercapnic respiratory failure. Between sessions of NIV, half of participants will have high flow nasal cannula while the others will have standard low flow oxygen therapy.

Detailed Description
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High Flow Nasal Cannula (HFNC) is a new way of oxygen therapy that has gained interest in the management of patients with acute respiratory failure. It allows reaching a high flow air up to 60 liters / min via a nasal cannula with a humidification and warming of the air administered. It has a number of physiological effects such as wash out of anatomical dead space, generation of a small PEEP and high inspired fraction of oxygen which enhances compliance and reduces inspiratory efforts. NIV is the corner stone in the treatment of severe COPD exacerbation. Nevertheless, prolonged application of the facial mask expose to local complications and intolerance which can be a cause of failure, so reducing the duration of exposure to this procedure is important. The role of HFNC in supplementing NIV effect during hypercapnic respiratory failure has not been assessed. Much of the data available on HFNC are about hypoxemic respiratory failure. Because of its physiological effects, it can be hypothesized that HFNC in addition to NIV can shorten its duration by facilitating carbon dioxide clearance.

Official Title
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High Flow Nasal Oxygen in Addition to Non Invasive Ventilation During Hypercapnic Respiratory Failure

Conditions
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Hypercapnic Respiratory Failure

Intervention / Treatment
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* Device: HFNC
* Device: standard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged more than 18 years with a diagnosis of acute-on-chronic respiratory failure and respiratory acidosis requiring NIV. Exclusion Criteria: Patient included in another study Patients intubated at ICU admission or within 12 hours Contraindication to NIV including: pneumothorax, Hemodynamic instability, GCS less than 12, facial malformation Asthma A do not intubate order Neuromuscular disease

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: standard group<br>NIV alternating with low oxygen therapy at 1 to 4 liters per minute to obtain SpO2 between 88% and 94%. | Device: standard<br>* patients will receive low flow oxygen therapy at 1 to 4 liters per minute<br>|
| Experimental: HFNC group<br>NIV alternating with HFNC delivering the equivalent inspired fraction of oxygen (FiO2) with a flow at 30 to 60 liters/min through an Optiflow nasal interface. | Device: HFNC<br>* patients will receive high flow warmed air with low inspired fraction of oxygen between non invasive ventilation sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of NIV | number of days patients received NIV, and for patients with home NIV: it is the number of days spent to achieve the usual daily NIV hours with clinical and gasometric stability | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to obtain NIV withdrawal criteria | the day patients do not have signs of acute respiratory failure and no respiratory acidosis (pH <7.36) | 28 days | 
| NIV failure | need for intubation or death | 28 days | 
| ICU length of stay | number of days spent in the ICU for this episode of exacerbation | 28 days | 
| ICU Mortality | death in the ICU during the recorded episode | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high flow oxygen, non invasive ventilation, hypercapnic respiratory failure