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

NCT03505814 | Unknown

• 1 other identifier: HEBechirHamza
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Weaning Failure

Keywords

post extubation care; neonatal surgical critical care; oxygen therapy; high nasal flow cannula

Outcome Measures

Primary Outcomes (1)

• reintubation rate

  need for mechanical ventilation support with tracheal intubation

  72 hours following prior weaning and extubation

Secondary Outcomes (7)

• incidence of post-extubation respiratory failure

  72 hours following prior weaning and extubation

• time to reintubate

  72 hours following prior weaning and extubation

• weaning time from oxygen.

  72 hours following prior weaning and extubation

• blood pressure

  72 hours following prior weaning and extubation

• heart rate

  72 hours following prior weaning and extubation

Study Arms (2)

Optiflow Group

EXPERIMENTAL

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®)

Control Group

ACTIVE COMPARATOR

Conventional oxygen therapy for post extubation care

Device: Conventional oxygen therapy

Interventions

High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®) DEVICE

High flow and humidified oxygen support for new borns and young infants for post-extubation care

Optiflow Group

Conventional oxygen therapy DEVICE

conventional oxygen support for new born and young infants in post-extubation care

Control Group

Eligibility Criteria

• Age: 1 Day - 45 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• need for mechanical ventilation
• tracheal intubation
• surgical intensive care admission
• availability of extubation criteria

You may not qualify if:

• prior extubation and mechanical ventilation to the actual episode
• weaning failure due to neurological status

Sponsors & Collaborators

• Hôpital d'enfants Béchir-Hamza: lead

Study Sites (1)

Hopital d'Enfants Bechir Hamza

Tunis, 1029, Tunisia

RECRUITING

Central Study Contacts

Ben Khalifa Sonia, Pr

CONTACT

0021698360939; benkhalifa_sonia@yahoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 23, 2018
• Study Start: March 1, 2017
• Primary Completion: August 31, 2018
• Study Completion: February 28, 2019
• Last Updated: April 23, 2018

Record last verified: 2018-04

Locations

TU (1)