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Recruiting NCT06483984

Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout

No phase Interventional Respiratory Insufficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Noninvasive ventilation.
Who it may be relevant to
Registry conditions: Respiratory Insufficiency. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Metabolic work of breathing [Time frame: 45 minutes]
Secondary outcome measures (11)
  • Normalized metabolic work of breathing [Time frame: 45 minutes]
  • Inspiratory effort, expressed in cmH2O [Time frame: 45 minutes]
  • Corrected minute ventilation [Time frame: 45 minutes]
  • Dyspnea [Time frame: 45 minutes]
  • Discomfort [Time frame: 45 minutes]
  • End-expiratory lung volume [Time frame: 45 minutes]
  • Regional End-expiratory lung volume [Time frame: 45 minutes]
  • Arterial carbon dioxide, expressed in mmHg [Time frame: 45 minutes]
  • Arterial acid-base state [Time frame: 45 minutes]
  • Recuitment of expiratory muscles, expressed in cmH2O of gastric pressure [Time frame: 45 minutes]
  • Tidal volume distribution [Time frame: 45 minutes]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 2 centers
  • General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS — Roma
  • Fondazione Policlinico Universitaro A. Gemelli IRCCS — Rome

Identifiers

NCT: NCT06483984 · 6462

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗