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

ConditionVentilation Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPapa Giovanni XXIII Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18 years,

Ability to give informed consent

Disqualifiers

known cardiac pathologies

known pulmonary pathologies

known vascular pathologies

history of concussion

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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°

  • 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°

Treatment groups

19 Participants
are divided into 2 treatment groups
Group A: HelmetExperimental treatment 1 intervention
Group B: Oronasal MaskActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Common carotid artery flow

Left common carotid artery flow, expressed as ml/min measured with pulsed wave doppler with ultrasound

Time frame
4 consecutive heart beats at the end of the intervention

Secondary outcomes

1

Mean arterial blood pressure

Non invasive mean arterial blood pressure on left arm

Time frame
single measure, at the end of the intervention
2

Peripheral vascular resistance

Peripheral vascular resistance measured in left common carotid artery, measured with pulsed wave doppler with ultrasound

Time frame
4 consecutive heart beats at the end of the intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Papa Giovanni XXIII Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: