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
About this trial
This is an interventional treatment trial for Rds
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
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
NCT ID
NCT02571231
First Posted
September 28, 2015
Last Updated
October 7, 2015
Sponsor
Oslo University Hospital
Collaborators
Haukeland University Hospital
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
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High Flow Ventilation With Volume Guarantee
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