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

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ClinicalTrials.gov Identifier: NCT03505814
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Sonia ben khalifa (PhD), Hôpital d'enfants Béchir-Hamza

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.


Condition or disease Intervention/treatment Phase
Weaning Failure Device: High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®) Device: Conventional oxygen therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Does High Flow Nasal Cannula Oxygen Therapy Prevent Reintubation in Pediatric Surgical Intensive Care Unit
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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




Primary Outcome Measures :
  1. reintubation rate [ Time Frame: 72 hours following prior weaning and extubation ]
    need for mechanical ventilation support with tracheal intubation


Secondary Outcome Measures :
  1. incidence of post-extubation respiratory failure [ Time Frame: 72 hours following prior weaning and extubation ]
    respiratory failure

  2. time to reintubate [ Time Frame: 72 hours following prior weaning and extubation ]
    time between first extubation and reintubation

  3. weaning time from oxygen. [ Time Frame: 72 hours following prior weaning and extubation ]
    time to wean from any oxygen supply

  4. blood pressure [ Time Frame: 72 hours following prior weaning and extubation ]
    blood pressure

  5. heart rate [ Time Frame: 72 hours following prior weaning and extubation ]
    heart rate

  6. respiratory rate [ Time Frame: 72 hours following prior weaning and extubation ]
    respiratory rate

  7. SpO2/FiO2 [ Time Frame: 72 hours following prior weaning and extubation ]
    pulsed oxygen saturation and inspired fraction of oxygen ratio



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Ages Eligible for Study:   up to 45 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505814


Contacts
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Contact: Ben Khalifa Sonia, Pr 0021698360939 benkhalifa_sonia@yahoo.fr

Locations
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Tunisia
Hopital d'Enfants Bechir Hamza Recruiting
Tunis, Tunisia, 1029
Contact: Benkhalifa Sonia, Pr    0021698360939    benkhalifa_sonia@yahoo.fr   
Sponsors and Collaborators
Hôpital d'enfants Béchir-Hamza

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Responsible Party: Dr Sonia ben khalifa (PhD), PROFESSOR, Hôpital d'enfants Béchir-Hamza
ClinicalTrials.gov Identifier: NCT03505814     History of Changes
Other Study ID Numbers: HEBechirHamza
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Sonia ben khalifa (PhD), Hôpital d'enfants Béchir-Hamza:
post extubation care
neonatal surgical critical care
oxygen therapy
high nasal flow cannula