Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout

NCT06483984 | Recruiting

• 1 other identifier: 6462
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

• Metabolic work of breathing

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

  45 minutes

Secondary Outcomes (11)

• Normalized metabolic work of breathing

  45 minutes

• Inspiratory effort, expressed in cmH2O

  45 minutes

• Corrected minute ventilation

  45 minutes

• Dyspnea

  45 minutes

• Discomfort

  45 minutes

Study Arms (3)

Facemask 'Nivairo'

ACTIVE COMPARATOR

Oronasal mask for noninvasive ventilation

Device: Noninvasive ventilation

Bridge-free facemask 'Visairo'

EXPERIMENTAL

Bridge-free facemask for noninvasive ventilation. This Bridge-Free NIV contacts the patient's nose only on the nostrils

Device: Noninvasive ventilation

Facemask 'Optiniv'

EXPERIMENTAL

Facemask for noninvasive ventilation favoring carbon dioxide washout

Device: Noninvasive ventilation

Interventions

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.

Also known as: Positive-pressure ventilation

Bridge-free facemask 'Visairo'; Facemask 'Nivairo'; Facemask 'Optiniv'

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute respiratory failure with
• PaCO2 ≥ 45 mmHg;
• Arterial pH \< 7.35;
• Signed written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (2)

General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS

Roma, Italy

RECRUITING

Fondazione Policlinico Universitaro A. Gemelli IRCCS

Rome, Italy

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation; Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Massimo Antonelli, MD

  Catholic University of the Sacred Heart

  STUDY CHAIR

Central Study Contacts

Domenico Luca Grieco, MD

CONTACT

+39063015; domenicoluca.grieco@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: July 3, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

IT (2)