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

NCT03505814 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2018-04-23

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Hôpital d'enfants Béchir-Hamza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
45 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-08-31
Completion
2019-02-28

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03505814 on ClinicalTrials.gov