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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard group | Active Comparator | NIV alternating with low oxygen therapy at 1 to 4 liters per minute to obtain SpO2 between 88% and 94%. |
|
| HFNC group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFNC | Device | patients will receive high flow warmed air with low inspired fraction of oxygen between non invasive ventilation sessions |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nejla Tilouche, MD | Contact | 0021623277911 | tilouche.nejla@gmail.com | |
| souheil elatrous, MD | Contact | 0021698403053 | souheilatrous@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive Care Unit | Recruiting | Mahdia | 5100 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26947372 | Background | Lepere V, Messika J, La Combe B, Ricard JD. High-flow nasal cannula oxygen supply as treatment in hypercapnic respiratory failure. Am J Emerg Med. 2016 Sep;34(9):1914.e1-2. doi: 10.1016/j.ajem.2016.02.020. Epub 2016 Feb 12. No abstract available. | |
| 25981908 | Result | Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D012015 | Reference Standards |
| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| D008919 | Investigative Techniques |
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| standard | Device | patients will receive low flow oxygen therapy at 1 to 4 liters per minute |
|
| 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 |