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OpenTrials
Completed

NCT Number: NCT06210386

Physiology of Helmet vs. Facemask Noninvasive Ventilation

The optimal noninvasive management of acute hypoxemic respiratory failure is debated. Helmet noninvasive ventilation may be more effective than facemask noninvasive ventilation for these patients. Putatitve benefits of helmet use are the possibility to apply significantly higher positive end-expiratory pressure without air leaks and with good patient's comfort.

In this randomized crossover study, the investigators will assess the physiological effects of helmet compared to facemask noninvasive ventilation, with the latter applied with different ventilator settings (similar to or different from helmet settings).

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Key information

Conditions

Acute Hypoxemic Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitaro A. Gemelli IRCCS

Rome, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute hypoxemic respiratory failure and PaO2/FiO2<200 mmHg
  • PaCO2<45 mmHg
  • Respiratory failure not caused by exacerbation of chronic pulmonary disease, cardiac failure or fluid overload

Exclusion criteria

  • Pregnancy
  • Contraindication to helmet or facemask noninvasive ventilation
  • Contraindication to esophageal manometry
  • Contraindication to electrical-impedance tomography monitoring
  • Recent surgery involving the abdomen or the thorax
  • Pneumothorax or documented barotrauma

Treatment and study plan

Noninvasive Ventilation

Device

noninvasive ventilation

Primary outcomes

  1. Inspiratory effort

    Time frame: 1 hour

    negative deflection in esophageal pressure

  2. End-expiratory lung impedance

    Time frame: 1 hour

    Electrical-impedance derived end-expiratory lung volume

Secondary outcomes

  1. Tidal volume

    Time frame: 1 hour

    Electrical-impedance derived tidal volume size

  2. Work of breathing

    Time frame: 1 hour

    Esophageal pressure simplified pressure-time product

  3. Respiratory rate

    Time frame: 1 hour

    Respiratory rate per minute

  4. Dynamic transpulmonary driving pressure

    Time frame: 1 hour

    Tidal change in transpulmonary pressure

  5. Compliance

    Time frame: 1 hour

    Ratio of tidal volume to transpulmonary driving pressure

  6. Dyspnea

    Time frame: 1 hour

    Dyspnea rated through a visual analog scale (ranging from 0 to 10, with representing most severe dyspnea) adapted for critically ill patients

  7. Discomfort

    Time frame: 1 hour

    Device-related discomfort (ranging from 0 to 10, with representing most severe dyspnea) rated through a visual analog scale adapted for critically ill patients

  8. Oxygenation

    Time frame: 1 hour

    PaO2/FiO2 ratio

  9. Pendelluft extent

    Time frame: 1 hour

    Pendelluft extent, expressed in % of the total tidal volume

  10. Corrected minute ventilation

    Time frame: 1 hour

    The product of tidal volume and respiratory rate, normalized to PaCO2. This value is expressed in Arbitrary units per minute divided by mmHg and is a proxy of dead space

  11. Arteria Carbon dioxide tension

    Time frame: 1 hour

    PaCO2

  12. Tidal volume distribution

    Time frame: 1 hour

    Tidal volume distribution, assessed with electrical impedance tomography in 4 regions of interest (ventral, mid-ventral, mid-dorsal, dorsal)

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Physiological Effects of Helmet vs. Facemask Noninvasive Ventilation in Acute Hypoxemic Respiratory Failure

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 18, 2024
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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