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

NCT06480253 | Not Yet Recruiting

• 1 other identifier: CBF - Helmet vs Mask
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilation Therapy

Keywords

Continuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mean arterial blood pressure

  single measure, at the end of the intervention

• Peripheral vascular resistance

  4 consecutive heart beats at the end of the intervention

Study Arms (2)

Helmet

EXPERIMENTAL

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

Device: Helmet Continuous Positive Airway Pressure

Oronasal Mask

ACTIVE COMPARATOR

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

Device: Oronasal Mask Continuous Positive Airway Pressure

Interventions

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°

Helmet

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°

Oronasal Mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Papa Giovanni XXIII Hospital: lead

Study Sites (1)

Ospedale Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

Related Publications (4)

• 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.

  PMID: 7978404 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.

  PMID: 12580765 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.

  PMID: 11098799 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.

  PMID: 22434361 BACKGROUND

Study Officials

• Roberto Cosentini, MD

  Ospedale Papa Giovanni XXIII

  STUDY DIRECTOR

Central Study Contacts

Andrea Duca, MD

CONTACT

+393396980738; a.duca85@gmail.com

Roberto Cosentini, MD

CONTACT

+390352678981; r.cosentini@asst-pg23.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Emergency Department

Model Details: Open Label, randomized, controlled with crossover

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 28, 2024
• Study Start: July 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be given on request for scientific porpoise after the publication of the results of the study
• Access Criteria: Data will be shared by email

Locations

IT (1)