An interventional study of High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®) and Conventional oxygen therapy in Weaning Failure, sponsored by Hôpital d'enfants Béchir-Hamza. Status unknown at 1 site in Tunisia. Open to participants aged 1 Day to 45 Days. Per ClinicalTrials.gov, last updated 2018-04-23.
Sponsored by Hôpital d'enfants Béchir-Hamza · Not applicable, Interventional, and Supportive care
monocentric randomized controlled trial starting from Mars 2017, recruitment is still ongoing. Patients aged between 0-45 days needing mechanical ventilation (MV) with tracheal intubation were included random assignation in two groups for post-extubation management: Group Optiflow (GO) for patients receiving High Flow Nasal Cannula Oxygen Therapy HNFC and Control Group (CG) for conventional treatment.
Patients were evaluated during the first 72h following extubation. Primary endpoint was the incidence of reintubation. Secondary endpoints were incidence of post-extubation respiratory failure, time to reintubate and weaning time from oxygen. Respiratory and hemodynamic parameters were assessed and compared between the two groups upon extubation, after 2 hours (H2), at H6, H12, H24, H36, H48 and H72. Length of stay (LOS) and mortality were also estimated.
We conducted a monocentric randomized controlled trial starting from Mars 2017, recruitment is still ongoing. Patients aged between 0-45 days needing mechanical ventilation (MV) with tracheal intubation were included regardless type of admission, severity of disease and randomly assigned in two groups for post-extubation management: Group Optiflow (GO) for patients receiving HNFC oxygen therapy and Control Group (CG) for conventional treatment. Before programmed extubation, newborns and young infants received 0.15 mg/kg of Dexamethasone. Patients were evaluated during the first 72h following extubation. Primary endpoint was the incidence of reintubation. Secondary endpoints were incidence of post-extubation respiratory failure, time to reintubate and weaning time from oxygen. Respiratory and hemodynamic parameters were assessed and compared between the two groups upon extubation, after 2 hours (H2), at H6, H12, H24, H36, H48 and H72. Length of stay (LOS) and mortality were also estimated.
Hôpital d'enfants Béchir-Hamza is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
high flow (6l/min), humidified oxygen administred into nasal cannula for post-extubation new born ventilated patients.
Device: High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®)
Conventional oxygen therapy for post extubation care
Device: Conventional oxygen therapy
High flow and humidified oxygen support for new borns and young infants for post-extubation care
conventional oxygen support for new born and young infants in post-extubation care
reintubation rate
need for mechanical ventilation support with tracheal intubation
Time frame: 72 hours following prior weaning and extubation
incidence of post-extubation respiratory failure
respiratory failure
Time frame: 72 hours following prior weaning and extubation
time to reintubate
time between first extubation and reintubation
Time frame: 72 hours following prior weaning and extubation
weaning time from oxygen.
time to wean from any oxygen supply
Time frame: 72 hours following prior weaning and extubation
blood pressure
blood pressure
Time frame: 72 hours following prior weaning and extubation
heart rate
heart rate
Time frame: 72 hours following prior weaning and extubation
respiratory rate
respiratory rate
Time frame: 72 hours following prior weaning and extubation
SpO2/FiO2
pulsed oxygen saturation and inspired fraction of oxygen ratio
Time frame: 72 hours following prior weaning and extubation
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Hôpital d'enfants Béchir-Hamza