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

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 Overview

• Status: Not yet recruiting
• Conditions: Ventilation Therapy
• Intervention / Treatment: Device: Helmet Continuous Positive Airway Pressure; Device: Oronasal Mask Continuous Positive Airway Pressure

• Study Type: Interventional
• Enrollment (Estimated): 19
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Duca, MD; Phone Number: +393396980738; Email: a.duca85@gmail.com
• Study Contact Backup: Name: Roberto Cosentini, MD; Phone Number: +390352678981; Email: r.cosentini@asst-pg23.it

Study Locations

• Italy
  • Bergamo, Italy, 24127
    • Ospedale Papa Giovanni XXIII
    • Contact: Roberto Cosentini, MD; Phone Number: +390352678981; Email: rcosentini@asst-pg23.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Helmet; Partecipants will be started on Continuous Positive Airway Pressure using the Helmet interface	Device: Helmet 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°
Active Comparator: Oronasal Mask; Partecipants will be started on Continuous Positive Airway Pressure using the oronasal mask interface	Device: Oronasal 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°

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	4 consecutive heart beats at the end of the intervention

Collaborators and Investigators

• Sponsor: Papa Giovanni XXIII Hospital
• Investigators: Study Director: Roberto Cosentini, MD, Ospedale Papa Giovanni XXIII

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure
• Other Study ID Numbers: CBF - Helmet vs Mask

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be given on request for scientific porpoise after the publication of the results of the study
• IPD Sharing Time Frame: IPD will be given on request for scientific porpoise after the publication of the results of the study
• IPD Sharing Access Criteria: Data will be shared by email
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No