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

Papa Giovanni XXIII Hospital

Status: Not yet enrolling

Conditions: Ventilation Therapy

Treatments: Device: Oronasal Mask Continuous Positive Airway Pressure; Device: Helmet Continuous Positive Airway Pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT06480253

CBF - Helmet vs Mask

Details and patient eligibility

About

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.

Enrollment: 19 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Helmet

Experimental group

Description:

Partecipants will be started on Continuous Positive Airway Pressure using the Helmet interface

Treatment:

Device: Helmet Continuous Positive Airway Pressure

Oronasal Mask

Active Comparator group

Description:

Partecipants will be started on Continuous Positive Airway Pressure using the oronasal mask interface

Treatment:

Device: Oronasal Mask Continuous Positive Airway Pressure