Clinical trial NCT03627598: High Flow Oxygen and Non Invasive Ventilation for Hypercapnic Respiratory Failure
Official title: High Flow Nasal Oxygen in Addition to Non Invasive Ventilation During Hypercapnic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypercapnic Respiratory Failure
Keywords: high flow oxygen
non invasive ventilation
hypercapnic respiratory failure
Lead sponsor: University Hospital, Mahdia
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: duration of NIV
timeFrame: 28 days
Secondary outcomes:
measure: Time to obtain NIV withdrawal criteria
timeFrame: 28 days
measure: NIV failure
timeFrame: 28 days
measure: ICU length of stay
timeFrame: 28 days
measure: ICU Mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Mahdia
country: Tunisia
facility: Intensive Care Unit
Study officials:
References:
citation: 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.
citation: 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.