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

Weaning Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03505814
• Other study ID #: HEBechirHamza
• Status: Recruiting
• Phase: N/A
• First received: April 3, 2018
• Last updated: April 13, 2018
• Start date: March 1, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: April 2018
• Source: Hôpital d'enfants Béchir-Hamza
• Contact: Ben Khalifa Sonia, Pr
• Phone: 0021698360939
• Email: benkhalifa_sonia[@]yahoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: February 28, 2019
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 45 Days

Eligibility

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

Related Conditions & MeSH terms

• Weaning Failure

Intervention

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

Locations

Country	Name	City	State
Tunisia	Hopital d'Enfants Bechir Hamza	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital d'enfants Béchir-Hamza

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reintubation rate	need for mechanical ventilation support with tracheal intubation	72 hours following prior weaning and extubation
Secondary	incidence of post-extubation respiratory failure	respiratory failure	72 hours following prior weaning and extubation
Secondary	time to reintubate	time between first extubation and reintubation	72 hours following prior weaning and extubation
Secondary	weaning time from oxygen.	time to wean from any oxygen supply	72 hours following prior weaning and extubation
Secondary	blood pressure	blood pressure	72 hours following prior weaning and extubation
Secondary	heart rate	heart rate	72 hours following prior weaning and extubation
Secondary	respiratory rate	respiratory rate	72 hours following prior weaning and extubation
Secondary	SpO2/FiO2	pulsed oxygen saturation and inspired fraction of oxygen ratio	72 hours following prior weaning and extubation