RecruitingNot ApplicableNCT06483984

Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout

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


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

20 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria7

  • 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.

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Interventions

DEVICENoninvasive ventilation

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


Locations(2)

General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS

Roma, Italy

Fondazione Policlinico Universitaro A. Gemelli IRCCS

Rome, Italy

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NCT06483984


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