RdsNCT02571231
High Flow Ventilation With Volume Guarantee
A study testing HFV + and - VG in people with Rds and Pulmonary Hypertension, run by Oslo University Hospital.
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). Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Rds, Pulmonary Hypertension, Meconium Aspiration Syndrome
- What is being tested?
- HFV + and - VG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all neonates in need of high frequency ventilator
Who cannot join
- neonates expected to need high frequency ventilator less than 48 hours because of planned surgery etc
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pilot Study: High Flow Ventilation With Volume Guarantee
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).
Read the 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).
- Conditions
- Rds, Pulmonary Hypertension, Meconium Aspiration Syndrome
- Being tested
- HFV + and - VG
- Medical subject headings
- Acute Lung Injury, Hypertension, Pulmonary, Meconium Aspiration Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFV + and - VGDevice
High frequency ventilation with and without volume guarantuee
| Study group | Role | What they receive |
|---|---|---|
| HFV+vg | Experimental | volume guarantee given Receives: Device: HFV + and - VG |
| HFV-VG | Experimental | Volume guarantee not given Receives: Device: HFV + and - VG |
What is being measured
The primary outcome is the main question the study is designed to answer.
stability of High Frequency Tidal volumes
HFVVt are measured by ventilator.
Measured: during study, ie. 48 hours.
Stability of CO2 measurements
Measured CO2 values will be measured as usual
Measured: during study, ie. 48 hours.
frequency of needed manual adjustments on the ventilator
Adjustments made on ventilator will be automatically sampled by the ventilator
Measured: during study, ie 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RdsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Sponsor
- Investigators
- Bjorn e Ogland, md dr philos, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571231
- Sponsor's protocol ID
- OsloUH_bogland
- Status last verified
- Sep 2015
- First submitted
- 28 Sep 2015
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: High Flow Ventilation With Volume Guarantee
- ClinicalTrials.gov ID
- NCT02571231
- Acronym / sponsor ID
- OsloUH_bogland
- Conditions
- Rds, Pulmonary Hypertension, Meconium Aspiration Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFV+vg | Experimental | Device: HFV + and - VGvolume guarantee given |
| HFV-VG | Experimental | Device: HFV + and - VGVolume guarantee not given |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all neonates in need of high frequency ventilator
Key exclusion criteria (1 listed)
- neonates expected to need high frequency ventilator less than 48 hours because of planned surgery etc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFV + and - VGHigh frequency ventilation with and without volume guarantuee | Device | HFV+vg, HFV-VG |
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bjorn e Ogland, md dr philos principal investigator
Oslo University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing HFV + and - VG in people with Rds and Pulmonary Hypertension, run by Oslo University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bjorn e Ogland, md, Dr Philos (+47 94979001, bjooeg@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stability of High Frequency Tidal volumes (time frame: during study, ie. 48 hours.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015.