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

Not Applicable

Not yet recruiting

• Conditions: Ventilation Therapy
• Interventions: Device: Helmet Continuous Positive Airway Pressure; Device: Oronasal Mask Continuous Positive Airway Pressure

• Registration Number: NCT06480253
• Lead Sponsor: Papa Giovanni XXIII Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-24
• Last Update Submitted: 2024-06-24
• Study First Posted: 2024-06-28
• Last Update Posted: 2024-06-28
• Study Start: 2024-07-01
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Helmet	Helmet Continuous Positive Airway Pressure	Partecipants will be started on Continuous Positive Airway Pressure using the Helmet interface
Oronasal Mask	Oronasal Mask Continuous Positive Airway Pressure	Partecipants will be started on Continuous Positive Airway Pressure using the oronasal mask interface

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ospedale Papa Giovanni XXIII; 🇮🇹 Bergamo, Italy