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

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.

Study Overview

• Status: Unknown
• Conditions: Weaning Failure
• Intervention / Treatment: Device: High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®); Device: Conventional oxygen therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia, 1029
    • Recruiting
    • Hopital d'Enfants Bechir Hamza
    • Contact: Benkhalifa Sonia, Pr; Phone Number: 0021698360939; Email: benkhalifa_sonia@yahoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optiflow Group; 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®); High flow and humidified oxygen support for new borns and young infants for post-extubation care
Active Comparator: Control Group; Conventional oxygen therapy for post extubation care	Device: Conventional oxygen therapy; conventional oxygen support for new born and young infants in post-extubation care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reintubation rate	need for mechanical ventilation support with tracheal intubation	72 hours following prior weaning and extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of post-extubation respiratory failure	respiratory failure	72 hours following prior weaning and extubation
time to reintubate	time between first extubation and reintubation	72 hours following prior weaning and extubation
weaning time from oxygen.	time to wean from any oxygen supply	72 hours following prior weaning and extubation
blood pressure	blood pressure	72 hours following prior weaning and extubation
heart rate	heart rate	72 hours following prior weaning and extubation
respiratory rate	respiratory rate	72 hours following prior weaning and extubation
SpO2/FiO2	pulsed oxygen saturation and inspired fraction of oxygen ratio	72 hours following prior weaning and extubation

Collaborators and Investigators

• Sponsor: Hôpital d'enfants Béchir-Hamza

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): August 31, 2018
• Study Completion (Anticipated): February 28, 2019

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (Actual): April 23, 2018

Study Record Updates

• Last Update Posted (Actual): April 23, 2018
• Last Update Submitted That Met QC Criteria: April 13, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: oxygen therapy; post extubation care; neonatal surgical critical care; high nasal flow cannula
• Other Study ID Numbers: HEBechirHamza

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No