Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout (MASHUP)

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

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

Study Overview

• Status: Recruiting
• Conditions: Respiratory Insufficiency
• Intervention / Treatment: Device: Noninvasive ventilation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Domenico Luca Grieco, MD; Phone Number: 4490 +39063015; Email: domenicoluca.grieco@unicatt.it

Study Locations

• Italy
  • Roma, Italy
    • Recruiting
    • General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS
    • Contact: Domenico Luca Grieco, MD; Phone Number: 4490 +39063015; Email: domenicoluca.grieco@unicatt.it
  • Rome, Italy
    • Recruiting
    • Fondazione Policlinico Universitaro A. Gemelli IRCCS
    • Contact: Domenico Luca Grieco, MD
    • Sub-Investigator: Antonio M Dell'Anna, MD
    • Sub-Investigator: Filippo Bongiovanni, MD
    • Sub-Investigator: Giuseppe Bello, MD
    • Sub-Investigator: Tommaso Rosà, MD
    • Sub-Investigator: Luca S Menga, MD
    • Sub-Investigator: Massimo Antonelli, MD
    • Sub-Investigator: Alessandro Cardu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Facemask 'Nivairo'; Oronasal mask for noninvasive ventilation	Device: Noninvasive ventilation; 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
Experimental: Bridge-free facemask 'Visairo'; Bridge-free facemask for noninvasive ventilation. This Bridge-Free NIV contacts the patient's nose only on the nostrils	Device: Noninvasive ventilation; 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
Experimental: Facemask 'Optiniv'; Facemask for noninvasive ventilation favoring carbon dioxide washout	Device: Noninvasive ventilation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic work of breathing	Simplified pressure-time-product per minute of the transdiaphragmatic pressure	45 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normalized metabolic work of breathing	Simplified pressure-time-product per minute of the transdiaphragmatic pressure normalized to arterial carbon dioxide divided by 45 mmHg	45 minutes
Inspiratory effort, expressed in cmH2O	Positive inspiratory deflection of transdiaphragmatic pressure	45 minutes
Corrected minute ventilation	Minute ventilation assessed with electrical impedence tomography, normalized to normalized to arterial carbon dioxide divided by 45 mmHg	45 minutes
Dyspnea	Dyspnoea, defined according to visual analog scale of dyspnea (0-10, where 10 represents worst perceivable dyspnea).	45 minutes
Discomfort	Discomfort, defined according to visual analog scale of discomfort (0-10, where 10 represents worst perceivable discomfort).	45 minutes
End-expiratory lung volume	Global impedance-derived end-expiratory lung volume (EELI), measured with electrical impedance tomography	45 minutes
Regional End-expiratory lung volume	Regional (ventral-midventral-middorsal-dorsal) impedance-derived end-expiratory lung volume (EELI), measured with electrical impedance tomography	45 minutes
Arterial carbon dioxide, expressed in mmHg	Arterial carbon dioxide, measured with arterial blood gas analysis	45 minutes
Arterial acid-base state	Arterial pH, measured with arterial blood gas analysis	45 minutes
Recuitment of expiratory muscles, expressed in cmH2O of gastric pressure	Expiratory increases in gastrinc pressure	45 minutes
Tidal volume distribution	Tidal volume distribution in the different lung regions (ventral-midventral-middorsal-dorsal),assessed with electrical impedance tomography	45 minutes

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Study Chair: Massimo Antonelli, MD, Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Therapeutics; Airway Management; Respiratory Therapy; Respiration, Artificial; Noninvasive Ventilation; Positive-Pressure Respiration
• Other Study ID Numbers: 6462

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No