Cerebral Blood Flow: Helmet vs Oronasal Mask During Continuous Positive Airway Pressure Ventilation

Variation of Cerebral Blood Flow Depending on the Interface Chosen During Continuous Positive Airway Pressure Ventilation

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06480253

Enrollment

Registered

2024-06-28

Start date

2024-07-01

Completion date

2024-07-31

Last updated

2024-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilation Therapy

Keywords

Continuous Positive Airway Pressure

Brief 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.

Interventions

DEVICEHelmet Continuous Positive Airway Pressure

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°

DEVICEOronasal Mask Continuous Positive Airway Pressure

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 design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Open Label, randomized, controlled with crossover

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Age ≥ 18 years, * Ability to give informed consent

Exclusion criteria

* known cardiac pathologies * known pulmonary pathologies * known vascular pathologies * history of concussion * history of headache

Design outcomes

Primary

Measure	Time frame	Description
Common carotid artery flow	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

Secondary

Measure	Time frame	Description
Mean arterial blood pressure	single measure, at the end of the intervention	Non invasive mean arterial blood pressure on left arm
Peripheral vascular resistance	4 consecutive heart beats at the end of the intervention	Peripheral vascular resistance measured in left common carotid artery, measured with pulsed wave doppler with ultrasound

Countries

Italy

Contacts

Primary ContactAndrea Duca, MD

a.duca85@gmail.com+393396980738

Backup ContactRoberto Cosentini, MD

r.cosentini@asst-pg23.it+390352678981

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026