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High Flow Ventilation With Volume Guarantee

Primary Purpose

Rds, Pulmonary Hypertension, Meconium Aspiration Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HFV + and - VG
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rds

Eligibility Criteria

undefined - 3 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all neonates in need of high frequency ventilator

Exclusion Criteria:

  • neonates expected to need high frequency ventilator less than 48 hours because of planned surgery etc

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    HFV+vg

    HFV-VG

    Arm Description

    volume guarantee given

    Volume guarantee not given

    Outcomes

    Primary Outcome Measures

    stability of High Frequency Tidal volumes
    HFVVt are measured by ventilator.
    Stability of CO2 measurements
    Measured CO2 values will be measured as usual
    frequency of needed manual adjustments on the ventilator
    Adjustments made on ventilator will be automatically sampled by the ventilator

    Secondary Outcome Measures

    Full Information

    First Posted
    September 28, 2015
    Last Updated
    October 7, 2015
    Sponsor
    Oslo University Hospital
    Collaborators
    Haukeland University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02571231
    Brief Title
    High Flow Ventilation With Volume Guarantee
    Official Title
    Pilot Study: High Flow Ventilation With Volume Guarantee
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    July 2016 (Anticipated)
    Study Completion Date
    July 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Oslo University Hospital
    Collaborators
    Haukeland University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The trial is a pilot study performed in the NICU's at Oslo University Hospital and Haukeland University Hospital preparing a multi-center randomized, controlled unblinded cross-over study, comparing high frequency ventilation (HFV) with and without volume guarantee (VG).
    Detailed Description
    HFV is a way to deliver mechanical breathing support to patients with respiratory failure applied in Neonatal Intensive Care Units (NICU's). In some NICU's, this mode of ventilation is applied when conventional ventilation fails, whereas in other units HFV is used as the primary ventilation mode. HFV is a ventilator mode where high frequency pressure changes, typically 6-12 per second (6 - 12 Hertz (Hz)), is used to exchange air between the lungs (alveoli) and the ventilator tubing. Concerns have been raised regarding fluctuating PCO2 values in babies receiving HFV. It is believed that stable normocapnia (normal PCO2 values) as opposed to hyper- and hypocapnia is associated to better short and long-term outcomes. In conventional ventilator modes, CO2 diffusion is a function of the product from volume per breath (Vt) and the frequency (f) of breathing (Vt*f = minute volume (MV)). In HFV the CO2 diffusion is a function of a product from the small tidal volumes generated (Vthf) squared, and the oscillation frequency (Hz) delivered by the ventilator (vthf2 * F=DCO2). The small tidal volumes are being adjusted by altering the pressure range (amplitude) and the frequency by which pressure changes is generated. One challenge in using HFV has been unwanted fluctuations in PCO2 values, which has been shown to be associated with clinical important complications, in particular cerebral hemorrhages. In order to avoid substantial fluctuation in PCO2 a meticulous adjustment of the amplitude is required. Modern neonatal ventilators now offer the ability to automatically adjust the amplitude of the high frequency breaths to obtain a stable high frequency tidal volume. The ventilator measures the Vthf and increase or decrease the power of each breath to obtain the set Vthf. This mode is called high frequency ventilation with volume guarantee (HFV+VG). Automatically adjustment of the amplitude is a novel option in high frequency ventlators and has not been studied in randomized trials. This study will investigate compare HFV with and without VG. Patients treated with HFV will be randomized to conventional HFV or HFV+VG. After 24 hours the mode will be changed to HFV+VG for those starting on HFV and to HFV for those starting on HFV+VG for 24 hours. After the trial period of 24 x 2 hours - the HFV mode will be at the clinician's preference. To compare the efficiency of both modes of HFV, measured PCO2 values, oxygen need and variables from the ventilator will be sampled. These variables describe the effort from the ventilator (frequency, amplitude) as well as variables associated with gas exchange in the lungs (Vthf, DCO2).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rds, Pulmonary Hypertension, Meconium Aspiration Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HFV+vg
    Arm Type
    Experimental
    Arm Description
    volume guarantee given
    Arm Title
    HFV-VG
    Arm Type
    Experimental
    Arm Description
    Volume guarantee not given
    Intervention Type
    Device
    Intervention Name(s)
    HFV + and - VG
    Intervention Description
    High frequency ventilation with and without volume guarantuee
    Primary Outcome Measure Information:
    Title
    stability of High Frequency Tidal volumes
    Description
    HFVVt are measured by ventilator.
    Time Frame
    during study, ie. 48 hours.
    Title
    Stability of CO2 measurements
    Description
    Measured CO2 values will be measured as usual
    Time Frame
    during study, ie. 48 hours.
    Title
    frequency of needed manual adjustments on the ventilator
    Description
    Adjustments made on ventilator will be automatically sampled by the ventilator
    Time Frame
    during study, ie 48 hours

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    3 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: all neonates in need of high frequency ventilator Exclusion Criteria: neonates expected to need high frequency ventilator less than 48 hours because of planned surgery etc
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bjorn e Ogland, md, Dr Philos
    Phone
    +47 94979001
    Email
    bjooeg@ous-hf.no
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bjorn e Ogland, md dr philos
    Organizational Affiliation
    Oslo University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    High Flow Ventilation With Volume Guarantee

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