Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout (MASHUP)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Respiratory Insufficiency

Treatments: Device: Noninvasive ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT06483984

6462

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Facemask 'Nivairo'

Active Comparator group

Description:

Oronasal mask for noninvasive ventilation

Treatment:

Device: Noninvasive ventilation

Bridge-free facemask 'Visairo'

Experimental group

Description:

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

Treatment:

Device: Noninvasive ventilation

Facemask 'Optiniv'

Experimental group

Description:

Facemask for noninvasive ventilation favoring carbon dioxide washout

Treatment:

Device: Noninvasive ventilation