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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Helmet | Experimental | Partecipants will be started on Continuous Positive Airway Pressure using the Helmet interface |
|
| Oronasal Mask | Active Comparator | Partecipants will be started on Continuous Positive Airway Pressure using the oronasal mask interface |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Helmet Continuous Positive Airway Pressure | Device | 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° |
| Measure | Description | Time Frame |
|---|---|---|
| Common carotid artery flow | Left common carotid artery flow, expressed as ml/min measured with pulsed wave doppler with ultrasound | 4 consecutive heart beats at the end of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Mean arterial blood pressure | Non invasive mean arterial blood pressure on left arm | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Duca, MD | Contact | +393396980738 | a.duca85@gmail.com | |
| Roberto Cosentini, MD | Contact | +390352678981 | r.cosentini@asst-pg23.it |
| Name | Affiliation | Role |
|---|---|---|
| Roberto Cosentini, MD | Ospedale Papa Giovanni XXIII | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Papa Giovanni XXIII | Bergamo | 24127 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7978404 | Background | 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. | |
| 12580765 | Background | Scala 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. |
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IPD will be given on request for scientific porpoise after the publication of the results of the study
IPD will be given on request for scientific porpoise after the publication of the results of the study
Data will be shared by email
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Open Label, randomized, controlled with crossover
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| Oronasal Mask Continuous Positive Airway Pressure | Device | 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° |
|
| 4 consecutive heart beats at the end of the intervention |
| 11098799 | Background | Kolbitsch 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. |
| 22434361 | Background | Yiallourou 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. |