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NCT Number: NCT06483984

Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout

The objective of this randomized cross-over trial is to assess the physiological effects of three different facemasks for noninvasive ventilation (Nivairo, Visairo, Optiniv) in patients with acute hypercapnic respiratory failure

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Key information

Conditions

Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS, Roma, Italy

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Acute respiratory failure with

  • PaCO2 ≥ 45 mmHg;
  • Arterial pH < 7.35;
  • Signed written informed consent

Exclusion criteria

  • Respiratory rate < 12 bpm;
  • Immediate need for intubation;
  • Haemodynamic instability (Systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg) and/or lactic acidosis (lactate >5 mmol/L) and/or clinically diagnosed shock;
  • Metabolic Acidosis;
  • Recent head surgery or anatomy that prevent the application of facemasks;
  • Any contraindications to oesophageal balloon insertion and/or electrical impedance tomography (EIT) belt placement.
  • Any contraindications to facemask noninvasive ventilation.

Treatment and study plan

Noninvasive Ventilation

Device

Respiratory support with a facemask connected to a ventilator through a heated humidifier. Ventilator will be set in the pressure support mode.

Other names: Positive-pressure ventilation

Primary outcomes

  1. Metabolic work of breathing

    Time frame: 45 minutes

    Simplified pressure-time-product per minute of the transdiaphragmatic pressure

Secondary outcomes

  1. Normalized metabolic work of breathing

    Time frame: 45 minutes

    Simplified pressure-time-product per minute of the transdiaphragmatic pressure normalized to arterial carbon dioxide divided by 45 mmHg

  2. Inspiratory effort, expressed in cmH2O

    Time frame: 45 minutes

    Positive inspiratory deflection of transdiaphragmatic pressure

  3. Corrected minute ventilation

    Time frame: 45 minutes

    Minute ventilation assessed with electrical impedence tomography, normalized to normalized to arterial carbon dioxide divided by 45 mmHg

  4. Dyspnea

    Time frame: 45 minutes

    Dyspnoea, defined according to visual analog scale of dyspnea (0-10, where 10 represents worst perceivable dyspnea).

  5. Discomfort

    Time frame: 45 minutes

    Discomfort, defined according to visual analog scale of discomfort (0-10, where 10 represents worst perceivable discomfort).

  6. End-expiratory lung volume

    Time frame: 45 minutes

    Global impedance-derived end-expiratory lung volume (EELI), measured with electrical impedance tomography

  7. Regional End-expiratory lung volume

    Time frame: 45 minutes

    Regional (ventral-midventral-middorsal-dorsal) impedance-derived end-expiratory lung volume (EELI), measured with electrical impedance tomography

  8. Arterial carbon dioxide, expressed in mmHg

    Time frame: 45 minutes

    Arterial carbon dioxide, measured with arterial blood gas analysis

  9. Arterial acid-base state

    Time frame: 45 minutes

    Arterial pH, measured with arterial blood gas analysis

  10. Recuitment of expiratory muscles, expressed in cmH2O of gastric pressure

    Time frame: 45 minutes

    Expiratory increases in gastrinc pressure

  11. Tidal volume distribution

    Time frame: 45 minutes

    Tidal volume distribution in the different lung regions (ventral-midventral-middorsal-dorsal),assessed with electrical impedance tomography

Study contacts

Contact information is provided by the study sponsor or research team.

Domenico Luca Grieco, MD

CONTACT

[email protected]

+39063015 ext. 4490

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Physiological Effects of Novel Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout in Patients With Hypercapnic Respiratory Failure

Acronym: MASHUP

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 3, 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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