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Automation of Oxygen Delivery in Spontaneous Ventilation (FreeO2) in Infants (FreeO2Bronchio)

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ClinicalTrials.gov Identifier: NCT03614507
Recruitment Status : Not yet recruiting
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:

The objective of this study is to demonstrate a decrease in the duration of hospitalization in case of first oxygen-dependent bronchiolitis thanks to the use of the FreeO2 system in infants less than 1 year old. The advantage of using FreeO2 system would be to shorten the duration of hospitalization.

FreeO2Bronchio is a multicenter, prospective, randomized, open-label study.


Condition or disease Intervention/treatment Phase
Bronchiolitis Device: FreeO2 (modèle FO2-220-00) automatic adjustment Device: FreeO2 (modèle FO2-220-00) manual adjustment Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a multicenter, prospective, randomized, open-label study. Patients will then be randomized to either the "FreeO2 Arm" or the "Manual Arm" for Oxygen Therapy with Manual Flow Adaptation.
Masking: None (Open Label)
Masking Description: The technology used does not allow blinding.
Primary Purpose: Treatment
Official Title: Automation of Oxygen Delivery in Spontaneous Ventilation (FreeO2) in Infants Under One Year Old With Bronchiolitis
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: FreeO2 Arm
Automatic adjustment of oxygen
Device: FreeO2 (modèle FO2-220-00) automatic adjustment
Automatic adjustment of oxygen through the "Free O2" device and in mode medical data collecting (SpO2)

Active Comparator: Manual Arm
Manual adjustment of oxygen
Device: FreeO2 (modèle FO2-220-00) manual adjustment
Manual adjustment of oxygen by the nurse or medical staff. The "Free O2" device will only be used in mode medical data collecting (SpO2)




Primary Outcome Measures :
  1. Duration of hospitalization in hours since the entrance to the emergency room. [ Time Frame: 30 days max ]
    The length of hospital stay in hours since arrival at the emergency room will be compared between the two groups.


Secondary Outcome Measures :
  1. Re-hospitalization within 7 days and 30 days [ Time Frame: 30 days max ]
  2. Frequency of use of ventilation (invasive or noninvasive ) [ Time Frame: 30 days max ]
  3. Transfer to continuous care units or resuscitation within 3 days [ Time Frame: 30 days max ]
  4. Nursing time in minutes spent at the bedside [ Time Frame: 30 days max ]
  5. Time spent in enteral nutrition on gastric tube in hours [ Time Frame: 30 days max ]
  6. Time spent under intravenous hydration in hours [ Time Frame: 30 days max ]
  7. Reports of AEs [ Time Frame: 30 days max ]
  8. Time spent in a area of severe desaturation (SpO2 <92%) and a hyperoxia area (SpO2> 98%). [ Time Frame: 30 days max ]
  9. Frequency of use of high-speed glasses (Optiflow) [ Time Frame: 30 days max ]


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Ages Eligible for Study:   1 Month to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children older than 1 month and less than 1 year of age who have a first episode of bronchiolitis and require oxygen therapy
  • Informed consent of parents
  • Affiliation to the social security system

Exclusion Criteria:

  • Need for an oxygen flow rate higher than 3 L / min to maintain SpO2 greater than 92%
  • Criteria of gravity justifying from the start another technique of respiratory assistance:

    • Polypnea: respiratory rate (FR)> 80 c / min.
    • Consciousness with glasgow score (GSC) <or = 12. Hemodynamic instability (mean arterial pressure (MAP) <- 2 SD for age or use of vasopressors).
    • Cardiac or respiratory arrest.
    • PCO2> 55 mm Hg and pH <7.35 if blood gas sample
  • Need for urgent surgery
  • Contraindication to the FreeO2 device as described in the user manual
  • Absence of informed consent of parents

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): NCT03614507


Contacts
Contact: Jean-Michel ROUE, Dr 02 98 22 36 67 ext +33 jean-michel.roue@chu-brest.fr

Locations
France
Angers, University Hospital Not yet recruiting
Angers, France, 49993
Contact: Françoise TROUSSIER, Dr       frtroussier@chu-angers.fr   
Brest, University Hospital Not yet recruiting
Brest, France, 29609
Contact: Jean-Michel ROUE, Dr       jean-michel.roue@chu-brest.fr   
Contact: Pierrick CROS, Dr       pierrick.cros@chu-brest.fr   
Marseille, University Hospital Not yet recruiting
Marseille, France, 13285
Contact: Ania CARSIN, Dr       ania.carsin@ap-hm.fr   
Nantes, University Hospital Not yet recruiting
Nantes, France, 44093
Contact: Tiphaine BIHOUEE, Dr       tiphaine.bihouee@chu-nantes.fr   
Rennes, university Hospital Not yet recruiting
Rennes, France, 35000
Contact: Clémentine VIGIER, Dr       clementine.vigier@chu-rennes.fr   
Sponsors and Collaborators
University Hospital, Brest
Investigators
Principal Investigator: Jean-Michel ROUE, Dr CHU de Brest

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03614507     History of Changes
Other Study ID Numbers: FreeO2Bronchio (29BRC18.0091)
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: June 2018

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

Keywords provided by University Hospital, Brest:
oxygen dependent
Infant Between 1 Month and 12 Months Old

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections