Ventilation TherapyNCT06480253
Cerebral Blood Flow: Helmet vs Oronasal Mask During Continuous Positive Airway Pressure Ventilation
A study testing Helmet Continuous Positive Airway Pressure and Oronasal Mask Continuous Positive Airway Pressure in people with Ventilation Therapy, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
Trial summary
In this trial the investigators will evaluate blood flow in common carotid artery of healthy subjects treated with Continuous Positive Airway Pressure (CPAP) Ventilation, comparing two different devices: oronasal mask versus Helmet. The hypothesis is that Helmet CPAP reduces carotid flow compared to oronasal mask. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventilation Therapy
- What is being tested?
- Helmet Continuous Positive Airway Pressure and Oronasal Mask Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2024to 31 Jul 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years,
- Ability to give informed consent
Who cannot join
- known cardiac pathologies
- known pulmonary pathologies
- known vascular pathologies
- history of concussion
- history of headache
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ospedale Papa Giovanni XXIII
Bergamo, 24127
Roberto Cosentini, MD, +390352678981, rcosentini@asst-pg23.it
About this study
Official title: Variation of Cerebral Blood Flow Depending on the Interface Chosen During Continuous Positive Airway Pressure Ventilation
In this trial the investigators will evaluate blood flow in common carotid artery of healthy subjects treated with Continuous Positive Airway Pressure (CPAP) Ventilation, comparing two different devices: oronasal mask versus Helmet. The hypothesis is that Helmet CPAP reduces carotid flow compared to oronasal mask.
- Conditions
- Ventilation Therapy
- Being tested
- Helmet Continuous Positive Airway Pressure, Oronasal Mask Continuous Positive Airway Pressure
- Keywords
- Continuous Positive Airway Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helmet Continuous Positive Airway PressureDevice
Partecipants will be started on Continuous Positive Airway Pressure at 10 cmH2O on inspired fraction of oxygen (FiO2)= 21% with the Helmet interface for a duration of 5 minutes while laying down on a stretcher with head elevated at 60°
Oronasal Mask Continuous Positive Airway PressureDevice
Partecipants will be started on Continuous Positive Airway Pressure at 10 cmH2O on Inspired fraction of oxygen (FiO2)= 21% with the oronasal mask interface for a duration of 5 minutes while laying down on a stretcher with head elevated at 60°
| Study group | Role | What they receive |
|---|---|---|
| Helmet | Experimental | Partecipants will be started on Continuous Positive Airway Pressure using the Helmet interface Receives: Device: Helmet Continuous Positive Airway Pressure |
| Oronasal Mask | Active comparator | Partecipants will be started on Continuous Positive Airway Pressure using the oronasal mask interface Receives: Device: Oronasal Mask Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Common carotid artery flow
Left common carotid artery flow, expressed as ml/min measured with pulsed wave doppler with ultrasound
Measured: 4 consecutive heart beats at the end of the intervention
Secondary outcomes (2)
Mean arterial blood pressure
Non invasive mean arterial blood pressure on left arm
Measured: single measure, at the end of the intervention
Peripheral vascular resistance
Peripheral vascular resistance measured in left common carotid artery, measured with pulsed wave doppler with ultrasound
Measured: 4 consecutive heart beats at the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ventilation TherapyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open Label, randomized, controlled with crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papa Giovanni XXIII Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Cosentini, Papa Giovanni XXIII Hospital
- Investigators
- Roberto Cosentini, MD, Study director, Ospedale Papa Giovanni XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480253
- Sponsor's protocol ID
- CBF - Helmet vs Mask
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be given on request for scientific porpoise after the publication of the results of the study
Publications
Haring HP, Hormann C, Schalow S, Benzer A. Continuous positive airway pressure breathing increases cerebral blood flow velocity in humans. Anesth Analg. 1994 Nov;79(5):883-5. doi: 10.1213/00000539-199411000-00011.
PubMed 7978404Scala R, Turkington PM, Wanklyn P, Bamford J, Elliott MW. Effects of incremental levels of continuous positive airway pressure on cerebral blood flow velocity in healthy adult humans. Clin Sci (Lond). 2003 Jun;104(6):633-9. doi: 10.1042/CS20020305.
PubMed 12580765Kolbitsch C, Lorenz IH, Hormann C, Schocke M, Kremser C, Zschiegner F, Felber S, Benzer A. The impact of increased mean airway pressure on contrast-enhanced MRI measurement of regional cerebral blood flow (rCBF), regional cerebral blood volume (rCBV), regional mean transit time (rMTT), and regional cerebrovascular resistance (rCVR) in human volunteers. Hum Brain Mapp. 2000 Nov;11(3):214-22. doi: 10.1002/1097-0193(200011)11:3<214::AID-HBM70>3.0.CO;2-I.
PubMed 11098799Yiallourou TI, Odier C, Heinzer R, Hirt L, Martin BA, Stergiopulos N, Haba-Rubio J. The effect of continuous positive airway pressure on total cerebral blood flow in healthy awake volunteers. Sleep Breath. 2013 Mar;17(1):289-96. doi: 10.1007/s11325-012-0688-0. Epub 2012 Mar 22.
PubMed 22434361
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation of Cerebral Blood Flow Depending on the Interface Chosen During Continuous Positive Airway Pressure Ventilation
- ClinicalTrials.gov ID
- NCT06480253
- Acronym / sponsor ID
- CBF - Helmet vs Mask
- Conditions
- Ventilation Therapy
- Keywords
- Continuous Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Papa Giovanni XXIII HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 28 Jun 2024 (actual)
- 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.
In this trial the investigators will evaluate blood flow in common carotid artery of healthy subjects treated with Continuous Positive Airway Pressure (CPAP) Ventilation, comparing two different devices: oronasal mask versus Helmet. The hypothesis is that Helmet CPAP reduces carotid flow compared to oronasal mask.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open Label, randomized, controlled with crossover
| Arm | Type | Receives |
|---|---|---|
| Helmet | Experimental | Device: Helmet Continuous Positive Airway PressurePartecipants will be started on Continuous Positive Airway Pressure using the Helmet interface |
| Oronasal Mask | Active comparator | Device: Oronasal Mask Continuous Positive Airway PressurePartecipants will be started on Continuous Positive Airway Pressure using the oronasal mask interface |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years,
- Ability to give informed consent
Key exclusion criteria (5 listed)
- known cardiac pathologies
- known pulmonary pathologies
- known vascular pathologies
- history of concussion
- history of headache
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 |
|---|---|---|
| Helmet Continuous Positive Airway PressurePartecipants will be started on Continuous Positive Airway Pressure at 10 cmH2O on inspired fraction of oxygen (FiO2)= 21% with the Helmet interface for a duration of 5 minutes while laying down on a stretcher with head elevated at 60° | Device | Helmet |
| Oronasal Mask Continuous Positive Airway PressurePartecipants will be started on Continuous Positive Airway Pressure at 10 cmH2O on Inspired fraction of oxygen (FiO2)= 21% with the oronasal mask interface for a duration of 5 minutes while laying down on a stretcher with head elevated at 60° | Device | Oronasal Mask |
Primary outcome
Common carotid artery flow
Time frame: 4 consecutive heart beats at the end of the intervention
Left common carotid artery flow, expressed as ml/min measured with pulsed wave doppler with ultrasound
2 secondary outcomes
Mean arterial blood pressure
Time frame: single measure, at the end of the intervention
Peripheral vascular resistance
Time frame: 4 consecutive heart beats at the end of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Background: PubMed 7978404Haring HP, Hormann C, Schalow S, Benzer A. Continuous positive airway pressure breathing increases cerebral blood flow velocity in humans. Anesth Analg. 1994 Nov;79(5):883-5. doi: 10.1213/00000539-199411000-00011.
- Background: PubMed 12580765Scala R, Turkington PM, Wanklyn P, Bamford J, Elliott MW. Effects of incremental levels of continuous positive airway pressure on cerebral blood flow velocity in healthy adult humans. Clin Sci (Lond). 2003 Jun;104(6):633-9. doi: 10.1042/CS20020305.
- Background: PubMed 11098799Kolbitsch C, Lorenz IH, Hormann C, Schocke M, Kremser C, Zschiegner F, Felber S, Benzer A. The impact of increased mean airway pressure on contrast-enhanced MRI measurement of regional cerebral blood flow (rCBF), regional cerebral blood volume (rCBV), regional mean transit time (rMTT), and regional cerebrovascular resistance (rCVR) in human volunteers. Hum Brain Mapp. 2000 Nov;11(3):214-22. doi: 10.1002/1097-0193(200011)11:3<214::AID-HBM70>3.0.CO;2-I.
- Background: PubMed 22434361Yiallourou TI, Odier C, Heinzer R, Hirt L, Martin BA, Stergiopulos N, Haba-Rubio J. The effect of continuous positive airway pressure on total cerebral blood flow in healthy awake volunteers. Sleep Breath. 2013 Mar;17(1):289-96. doi: 10.1007/s11325-012-0688-0. Epub 2012 Mar 22.
- Individual participant dataSharing planned: Yes. IPD will be given on request for scientific porpoise after the publication of the results of the study
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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.
Roberto Cosentini, MD study director
Ospedale Papa Giovanni XXIII
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helmet Continuous Positive Airway Pressure and Oronasal Mask Continuous Positive Airway Pressure in people with Ventilation Therapy, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
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 2 inclusion and 5 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 28 Jun 2024. 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 Italy. 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 Andrea Duca, MD (+393396980738, a.duca85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Common carotid artery flow (time frame: 4 consecutive heart beats at the end of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06480253, which also lists 4 linked publications.
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 28 Jun 2024.