Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout

Fondazione Policlinico Universitario Agostino Gemelli IRCCS20 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Respiratory Insufficiency

Interventions

Noninvasive ventilationDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS

Roma, Italy

RECRUITING

Fondazione Policlinico Universitaro A. Gemelli IRCCS

Rome, Italy

RECRUITING

Outcomes

Primary Outcomes

Metabolic work of breathing

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

Time frame: 45 minutes

Secondary Outcomes

Normalized metabolic work of breathing

Simplified pressure-time-product per minute of the transdiaphragmatic pressure normalized to arterial carbon dioxide divided by 45 mmHg

Time frame: 45 minutes

Inspiratory effort, expressed in cmH2O

Positive inspiratory deflection of transdiaphragmatic pressure

Time frame: 45 minutes

Corrected minute ventilation

Minute ventilation assessed with electrical impedence tomography, normalized to normalized to arterial carbon dioxide divided by 45 mmHg

Time frame: 45 minutes

Dyspnea

Dyspnoea, defined according to visual analog scale of dyspnea (0-10, where 10 represents worst perceivable dyspnea).

Time frame: 45 minutes

Discomfort

Discomfort, defined according to visual analog scale of discomfort (0-10, where 10 represents worst perceivable discomfort).

Time frame: 45 minutes

End-expiratory lung volume

Global impedance-derived end-expiratory lung volume (EELI), measured with electrical impedance tomography

Time frame: 45 minutes

Regional End-expiratory lung volume

Regional (ventral-midventral-middorsal-dorsal) impedance-derived end-expiratory lung volume (EELI), measured with electrical impedance tomography

Central Contacts

Domenico Luca Grieco, MD

CONTACT

+39063015 domenicoluca.grieco@unicatt.it

Data from ClinicalTrials.gov

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