Weaning Failure
Conditions
Keywords
post extubation care, neonatal surgical critical care, oxygen therapy, high nasal flow cannula
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHigh Flow Nasal Cannula Oxygen therapy (OPTIFLOW®)
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
Sponsors
Hôpital d'enfants Béchir-Hamza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 45 Days
Healthy volunteers
No
Inclusion criteria
* need for mechanical ventilation * tracheal intubation * surgical intensive care admission * availability of extubation criteria
Exclusion criteria
* prior extubation and mechanical ventilation to the actual episode * weaning failure due to neurological status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reintubation rate | 72 hours following prior weaning and extubation | need for mechanical ventilation support with tracheal intubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to reintubate | 72 hours following prior weaning and extubation | time between first extubation and reintubation |
| weaning time from oxygen. | 72 hours following prior weaning and extubation | time to wean from any oxygen supply |
| blood pressure | 72 hours following prior weaning and extubation | blood pressure |
| incidence of post-extubation respiratory failure | 72 hours following prior weaning and extubation | respiratory failure |
| respiratory rate | 72 hours following prior weaning and extubation | respiratory rate |
| SpO2/FiO2 | 72 hours following prior weaning and extubation | pulsed oxygen saturation and inspired fraction of oxygen ratio |
| heart rate | 72 hours following prior weaning and extubation | heart rate |
Countries
Tunisia
Contacts
Primary ContactBen Khalifa Sonia, Pr
Outcome results
None listed