Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout

Last updated: November 18, 2024
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Treatment

Noninvasive ventilation

Clinical Study ID

NCT06483984
6462
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

Acute respiratory failure with

  • PaCO2 ≥ 45 mmHg;

  • Arterial pH < 7.35;

  • Signed written informed consent

Exclusion

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 diagnosedshock;

  • Metabolic Acidosis;

  • Recent head surgery or anatomy that prevent the application of facemasks;

  • Any contraindications to oesophageal balloon insertion and/or electrical impedancetomography (EIT) belt placement.

  • Any contraindications to facemask noninvasive ventilation.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Noninvasive ventilation
Phase:
Study Start date:
November 15, 2024
Estimated Completion Date:
October 01, 2025

Connect with a study center

  • General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS

    Roma,
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitaro A. Gemelli IRCCS

    Rome,
    Italy

    Active - Recruiting

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