High Flow Ventilation With Volume Guarantee

Pulmonary Hypertension Clinical Trial

Official title:

Pilot Study: High Flow Ventilation With Volume Guarantee

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02571231
• Other study ID #: OsloUH_bogland
• Status: Not yet recruiting
• Phase: N/A
• First received: September 28, 2015
• Last updated: October 7, 2015
• Start date: November 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2015
• Source: Oslo University Hospital
• Contact: Bjorn e Ogland, md, Dr Philos
• Phone: +47 94979001
• Email: bjooeg[@]ous-hf.no
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Meconium Aspiration Syndrome
• Pulmonary Hypertension
• Rds

Intervention

Device:
• HFV + and - VG
High frequency ventilation with and without volume guarantuee

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Haukeland University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stability of High Frequency Tidal volumes	HFVVt are measured by ventilator.	during study, ie. 48 hours.	No
Primary	Stability of CO2 measurements	Measured CO2 values will be measured as usual	during study, ie. 48 hours.	No
Primary	frequency of needed manual adjustments on the ventilator	Adjustments made on ventilator will be automatically sampled by the ventilator	during study, ie 48 hours	No