High Flow Ventilation With Volume Guarantee

Sponsor

Oslo University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02571231

Collaborator

Haukeland University Hospital (Other)

Enrollment

Arms

Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Rds Pulmonary Hypertension Meconium Aspiration Syndrome	Device: HFV + and - VG	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pilot Study: High Flow Ventilation With Volume Guarantee

Study Start Date :

Nov 1, 2015

Anticipated Primary Completion Date :

Jul 1, 2016

Anticipated Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HFV+vg volume guarantee given	Device: HFV + and - VG High frequency ventilation with and without volume guarantuee
Experimental: HFV-VG Volume guarantee not given	Device: HFV + and - VG High frequency ventilation with and without volume guarantuee

Arm

Intervention/Treatment

Experimental: HFV+vg

volume guarantee given

Device: HFV + and - VG

High frequency ventilation with and without volume guarantuee

Experimental: HFV-VG

Volume guarantee not given

Device: HFV + and - VG

High frequency ventilation with and without volume guarantuee

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 3 Months

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Oslo University Hospital
Haukeland University Hospital

Investigators

Principal Investigator: Bjorn e Ogland, md dr philos, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT02571231

Other Study ID Numbers:

OsloUH_bogland

First Posted:

Oct 8, 2015

Last Update Posted:

Oct 8, 2015

Last Verified:

Sep 1, 2015

Additional relevant MeSH terms:

Hypertension, Pulmonary

Meconium Aspiration Syndrome

Study Results

No Results Posted as of Oct 8, 2015