High Flow Oxygen and Non Invasive Ventilation for Hypercapnic Respiratory Failure
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|ClinicalTrials.gov Identifier: NCT03627598|
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypercapnic Respiratory Failure||Device: HFNC Device: standard||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||High Flow Nasal Oxygen in Addition to Non Invasive Ventilation During Hypercapnic Respiratory Failure|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||October 2019|
Active Comparator: standard group
NIV alternating with low oxygen therapy at 1 to 4 liters per minute to obtain SpO2 between 88% and 94%.
patients will receive low flow oxygen therapy at 1 to 4 liters per minute
Experimental: HFNC group
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.
patients will receive high flow warmed air with low inspired fraction of oxygen between non invasive ventilation sessions
- duration of NIV [ Time Frame: 28 days ]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
- Time to obtain NIV withdrawal criteria [ Time Frame: 28 days ]the day patients do not have signs of acute respiratory failure and no respiratory acidosis (pH <7.36)
- NIV failure [ Time Frame: 28 days ]need for intubation or death
- ICU length of stay [ Time Frame: 28 days ]number of days spent in the ICU for this episode of exacerbation
- ICU Mortality [ Time Frame: 28 days ]death in the ICU during the recorded episode
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627598
|Contact: Nejla Tilouche, MDfirstname.lastname@example.org|
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