Clinical trial NCT03505814: Interest of High Flow Nasal Cannula Oxygen Therapy in Pediatric Intensive Care Unit
Official title: Does High Flow Nasal Cannula Oxygen Therapy Prevent Reintubation in Pediatric Surgical Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weaning Failure
Keywords: post extubation care
neonatal surgical critical care
oxygen therapy
high nasal flow cannula
Lead sponsor: Hôpital d'enfants Béchir-Hamza
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 126
Sex: ALL
Minimum age (years): 1
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: reintubation rate
timeFrame: 72 hours following prior weaning and extubation
Secondary outcomes:
measure: incidence of post-extubation respiratory failure
timeFrame: 72 hours following prior weaning and extubation
measure: time to reintubate
timeFrame: 72 hours following prior weaning and extubation
measure: weaning time from oxygen.
timeFrame: 72 hours following prior weaning and extubation
measure: blood pressure
timeFrame: 72 hours following prior weaning and extubation
measure: heart rate
timeFrame: 72 hours following prior weaning and extubation
measure: respiratory rate
timeFrame: 72 hours following prior weaning and extubation
measure: SpO2/FiO2
timeFrame: 72 hours following prior weaning and extubation
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Hopital d'Enfants Bechir Hamza
Study officials:
References: