Patients at the Intensive Care Unit (ICU)NCT02545803
The Effect of High Frequency Percussive Ventilation on Cerebral Tissue Oxygenation
A study testing Near-Infrared Spectroscopy (NIRS) in people with Patients at the Intensive Care Unit (ICU), run by Hasselt University at 1 site in Belgium.
Trial summary
Hypoxemia is commonly reported in patients admitted to the Intensive Care Unit (ICU) and may result from acute lung injury/acute respiratory distress syndrome (ALI/ARDS), sepsis, trauma and postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients at the Intensive Care Unit (ICU)
- What is being tested?
- Near-Infrared Spectroscopy (NIRS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- May 2015to May 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥ 18 years) at the Intensive Care Unit (ICU) who become refractory to conventional mechanical ventilation and are switched to HFPV.
Who cannot join
- Age < 18 years
- Patients with COPD (chronic obstructive pulmonary disease)
- Patients with asthma
Trial locations and contacts
1 site in 1 country.
Ward Eertmans, drs. contact
Frank Jans, prof. dr. contact
Belgium1 site, 1 recruiting
- Recruiting
Ziekenhuis Oost-Limburg
Genk, 3600
Ward Eertmans, drs., ward.eertmans@uhasselt.be
Frank Jans, prof. dr.
About this study
Hypoxemia is commonly reported in patients admitted to the Intensive Care Unit (ICU) and may result from acute lung injury/acute respiratory distress syndrome (ALI/ARDS), sepsis, trauma and postoperative complications. In an attempt to preserve or increase the oxygenation, conventional mechanical ventilation is initiated in these patients. Unfortunately, patients frequently become refractory to standard ventilatory techniques and as such, gas exchange remains unaltered or becomes worse. High Frequency Percussive Ventilation (HFPV), on the other hand, is an advanced mode of ventilation which can be a salvage option in these patient cohorts as it has already been proven to improve gas exchange with success. The volumetric diffusive respirator (VDR-4; Percussionary, Corp., Sandpoint, ID) is the only commercially available system to deliver HFPV. This ventilator mechanically ventilates the lung by administering small successive subtidal volumes or percussions at unconventional high frequencies to reach an optimal diffusive oxygenation.
Since it has been known that hypoxemia due to a reduced oxygenation results in secondary brain injury, it is conceivable that the cerebral tissue oxygenation might be impaired as well. It has been strongly suggested that a cerebral tissue oxygenation in the optimal range has an ameliorative influence on hypoxic events and in turn leads to a better clinical outcome. Thus far, no studies have been conducted to investigate if an improved oxygenation by means of a switch to HFPV automatically leads to an increment in the cerebral tissue oxygenation. With the use of Near-Infrared Spectroscopy (NIRS) technology, investigators will investigate whether this alternation of ventilation strategy is associated with a (beneficial) change of the cerebral tissue oxygenation.
- Being tested
- Near-Infrared Spectroscopy (NIRS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-Infrared Spectroscopy (NIRS)Device
Near infrared spectroscopy (NIRS) is a non-invasive technique that uses near infrared light between 700 and 1100nm which penetrates several centimeters through skin and bone structures. Light is absorbed by chromophores. There are multiple chromophores which can be detected in the NIR spectrum such as water, lipids, melanin, myoglobin, oxygenated hemoglobin and deoxygenated hemoglobin. Each chromophore has a specific absorption spectrum. By using different wavelengths, it is possible to differentiate chromophores. The difference between oxygenated hemoglobin and deoxygenated hemoglobin can be calculated using the modified Beer-Lambert law, resulting in a numeric value which is a representation of the regional cerebral oxygen saturation
| Study group | Role | What they receive |
|---|---|---|
| study group | Other | Adult patients (age ≥ 18 years) at the Intensive Care Unit (ICU) who become refractory to conventional mechanical ventilation and are switched to HFPV. Receives: Device: Near-Infrared Spectroscopy (NIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between HFPV and cerebral oxygen saturation
The primary objective is to investigate whether a switch from conventional mechanical ventilation to High Frequency Percussive Ventilation is associated with a change of the SctO2. Therefore, a comparison of SctO2-values two hours before and four hours after the switch will be made.
Measured: Two hours before switch to HFPV until 24 hours after the switch to HFPV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients at the Intensive Care Unit (ICU)Studies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Responsible party
- Principal investigator, prof. dr. Frank Jans, Hasselt University
- Investigators
- Frank Jans, prof. dr., Principal investigator, Ziekenhuis Oost-Limburg, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545803
- Sponsor's protocol ID
- VDR4_ZOL1
- Status last verified
- Mar 2018
- First submitted
- 20 Aug 2015
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Frequency Percussive Ventilation on Cerebral Tissue Oxygenation
- ClinicalTrials.gov ID
- NCT02545803
- Acronym / sponsor ID
- VDR4_ZOL1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Study start
- May 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 10 Sep 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.
Hypoxemia is commonly reported in patients admitted to the Intensive Care Unit (ICU) and may result from acute lung injury/acute respiratory distress syndrome (ALI/ARDS), sepsis, trauma and postoperative complications. In an attempt to preserve or increase the oxygenation, conventional mechanical ventilation is initiated in these patients. Unfortunately, patients frequently become refractory to standard ventilatory techniques and as such, gas exchange remains unaltered or becomes worse. High Frequency Percussive Ventilation (HFPV), on the other hand, is an advanced mode of ventilation which can be a salvage option in these patient cohorts as it has already been proven to improve gas exchange with success. The volumetric diffusive respirator (VDR-4; Percussionary, Corp., Sandpoint, ID) is the only commercially available system to deliver HFPV. This ventilator mechanically ventilates the lung by administering small successive subtidal volumes or percussions at unconventional high frequencies to reach an optimal diffusive oxygenation.
Since it has been known that hypoxemia due to a reduced oxygenation results in secondary brain injury, it is conceivable that the cerebral tissue oxygenation might be impaired as well. It has been strongly suggested that a cerebral tissue oxygenation in the optimal range has an ameliorative influence on hypoxic events and in turn leads to a better clinical outcome. Thus far, no studies have been conducted to investigate if an improved oxygenation by means of a switch to HFPV automatically leads to an increment in the cerebral tissue oxygenation. With the use of Near-Infrared Spectroscopy (NIRS) technology, investigators will investigate whether this alternation of ventilation strategy is associated with a (beneficial) change of the cerebral tissue oxygenation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Other | Device: Near-Infrared Spectroscopy (NIRS)Adult patients (age ≥ 18 years) at the Intensive Care Unit (ICU) who become refractory to conventional mechanical ventilation and are switched to HFPV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (age ≥ 18 years) at the Intensive Care Unit (ICU) who become refractory to conventional mechanical ventilation and are switched to HFPV.
Key exclusion criteria (3 listed)
- Age < 18 years
- Patients with COPD (chronic obstructive pulmonary disease)
- Patients with asthma
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 |
|---|---|---|
| Near-Infrared Spectroscopy (NIRS)Near infrared spectroscopy (NIRS) is a non-invasive technique that uses near infrared light between 700 and 1100nm which penetrates several centimeters through skin and bone structures. Light is absorbed by chromophores. There are multiple chromophores which can be detected in the NIR spectrum such as water, lipids, melanin, myoglobin, oxygenated hemoglobin and deoxygenated hemoglobin. Each chromophore has a specific absorption spectrum. By using different wavelengths, it is possible to differentiate chromophores. The difference between oxygenated hemoglobin and deoxygenated hemoglobin can be calculated using the modified Beer-Lambert law, resulting in a numeric value which is a representation of the regional cerebral oxygen saturation | Device | study group |
Primary outcome
The association between HFPV and cerebral oxygen saturation
Time frame: Two hours before switch to HFPV until 24 hours after the switch to HFPV
The primary objective is to investigate whether a switch from conventional mechanical ventilation to High Frequency Percussive Ventilation is associated with a change of the SctO2. Therefore, a comparison of SctO2-values two hours before and four hours after the switch will be made.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
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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.
Ward Eertmans, drs. contact
Frank Jans, prof. dr. contact
Frank Jans, prof. dr. principal investigator
Ziekenhuis Oost-Limburg, Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near-Infrared Spectroscopy (NIRS) in people with Patients at the Intensive Care Unit (ICU), run by Hasselt University at 1 site in Belgium.
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 3 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 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ward Eertmans, drs. (ward.eertmans@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association between HFPV and cerebral oxygen saturation (time frame: Two hours before switch to HFPV until 24 hours after the switch to HFPV). 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 27 Mar 2018.