Interest of High Flow Nasal Cannula Oxygen Therapy in Pediatric Intensive Care Unit

Hôpital d'enfants Béchir-Hamza

Status: Unknown

Conditions: Weaning Failure

Treatments: Device: High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®); Device: Conventional oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03505814

HEBechirHamza

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 1 to 45 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 2 patient groups

Optiflow Group

Experimental group

Description:

high flow (6l/min), humidified oxygen administred into nasal cannula for post-extubation new born ventilated patients.

Treatment:

Device: High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®)

Control Group

Active Comparator group

Description:

Conventional oxygen therapy for post extubation care

Treatment:

Device: Conventional oxygen therapy