An interventional study of HFNC and standard in Hypercapnic Respiratory Failure, sponsored by University Hospital, Mahdia. Status unknown at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-13.
Sponsored by University Hospital, Mahdia · Not applicable, Interventional, and Treatment
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.
1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 860 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →University Hospital, Mahdia is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NIV alternating with low oxygen therapy at 1 to 4 liters per minute to obtain SpO2 between 88% and 94%.
Device: standard
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
patients will receive high flow warmed air with low inspired fraction of oxygen between non invasive ventilation sessions
patients will receive low flow oxygen therapy at 1 to 4 liters per minute
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
Time frame: 28 days
Time to obtain NIV withdrawal criteria
the day patients do not have signs of acute respiratory failure and no respiratory acidosis (pH \<7.36)
Time frame: 28 days
NIV failure
need for intubation or death
Time frame: 28 days
ICU length of stay
number of days spent in the ICU for this episode of exacerbation
Time frame: 28 days
ICU Mortality
death in the ICU during the recorded episode
Time frame: 28 days
Started Jul 2018 (actual). Primary completion is estimated for Aug 2019, 13 months after the start.
Of 359 non-industry interventional studies with no phase under Respiratory Insufficiency, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 13 months is below that.
Counting every sponsor, half of 375 studies reached it within 24 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Mahdia