Clinical Trial: High Flow Ventilation With Volume Guarantee

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Pilot Study: High Flow Ventilation With Volume Guarantee

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 Summary:

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 ea
Sponsor: Oslo University Hospital

Current Primary Outcome:

  • stability of High Frequency Tidal volumes [ Time Frame: during study, ie. 48 hours. ]
    HFVVt are measured by ventilator.
  • Stability of CO2 measurements [ Time Frame: during study, ie. 48 hours. ]
    Measured CO2 values will be measured as usual
  • frequency of needed manual adjustments on the ventilator [ Time Frame: during study, ie 48 hours ]
    Adjustments made on ventilator will be automatically sampled by the ventilator


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Oslo University Hospital

Dates:
Date Received: September 28, 2015
Date Started: November 2015
Date Completion: July 2016
Last Updated: October 7, 2015
Last Verified: September 2015