NCT03505814

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

Does High Flow Nasal Cannula Oxygen Therapy Prevent Reintubation in Pediatric Surgical Intensive Care Unit

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Hôpital d'enfants Béchir-Hamza · Academic / Other
• Sex: All
• Age: 1 Day – 45 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Weaning Failure

Interventions

Type	Name	Description
DEVICE	High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®)	High flow and humidified oxygen support for new borns and young infants for post-extubation care
DEVICE	Conventional oxygen therapy	conventional oxygen support for new born and young infants in post-extubation care

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-08-31
• Completion: 2019-02-28
• First posted: 2018-04-23
• Last updated: 2018-04-23

Locations

1 site across 1 country: Tunisia