None listed
Conditions
Brief summary
In patients affected by severe exacerbation of chronic respiratory failure (SE-CRF), with worsened hypercapnia and respiratory acidosis, the sole oxygen therapy is not enough and a ventilatory assistance is required, most of the time through a mask or helmet, so call non-invasive ventilation. The advantage of NIV is to guarantee a ventilatory assistance, avoiding complications related to the presence of the endotracheal tube, such as ventilator associated pneumonia. Furthermore, it has been widely shown that, in patients with SE-CRF, NIV reduces the mortality rate, as opposed to invasive mechanical ventilation. However, NIV is a "bridge-therapy", applied in the attempt to permit the pharmacological treatments (i.e. antibiotics and bronchodilators) solve the underlying reason of exacerbation; afterwards, patients can be weaned from NIV, and, whenever required, starts oxygen therapy. Among devices for oxygen therapy, Venturi mask is frequently used in Intensive Care Unit (ICU), because it is possible to provide a nominal fraction of inspired oxygen (FiO2) between 24 and 60%. Recently a new device has become commercially available (Optiflow, Fisher & Paykel, New Zealand) able to provide high flow of heated and humidified gas through nasal cannula. The humidification of gas flow reduces the risk of mucosa dryness and airway muco-ciliar clearence. The use of high-flow of gas (up to 60L/min) permits to provide accurate FiO2 during all the inspiratory phase and to wash out the naso-pharyngeal dead space, in addition to the application of a minimal positive pressure. In patients with hypoxemic acute respiratory failures of mild to moderate degree, Optiflow has been shown to be better tolerated and to guarantee a better oxygenation, in comparison with Venturi mask. Moreover, in another study a high-flow oxygen-therapy system has been shown to reduce the respiratory rate in patients with CRF and the arterial partial pressure of carbon dioxide (PaCO2). Basing on these data, the Optiflow system could potentially positively influence the inspiratory effort of patients experiencing SE-CRF, when compared to Venturi mask. Though both commonly used in clinical practice, nowadays no study has compared Optiflow with Venturi mask at this regard. We aim to evaluate if some differences in respiratory effort exists between Venturi mask and Optiflow, in patients recovering from SE-CRF, through a diaphragm ultrasonogaphy evaluation.
Interventions
After obtaining written informed consent, the patient will undergo to 5 consecutive 30-minute trials: 1) Non-Invasive Ventilation (NIV_1); 2) Venturi mask; 3) Non-Invasive Ventilation (NIV_2); 4) Optiflow; 5) Non-Invasive Ventilation (NIV_3). The sequence of Venturi mask and Optiflow trials will be randomized, according to a sequence generated by a computer. During non-invasive ventilation (NIV) trials (NIV_1, NIV_2 and NIV_3), the inspiratory support will be given with a dedicated ventilator for NIV, in Pressure Support Ventilation mode, through a mask, as clinically indicated. The Optiflow will be initially set with the highest flow value between 50-60 L/min, according to the patient's tolerance. The nasal cannula size will be appropriately chosen. Moreover, the temperature of the heater will be set at 37 degrees During all trials, FiO2 will be kept unchanged, in order to assure an arterial saturation in O2 > 94% (SpO2).
Sponsors
Study design
Eligibility
Inclusion criteria
All the patients meeting the following criteria will be eligible for the study: 1) age equal or greater than 18 years; 2) presence of consciousness; 3) previous NIV for at least 24 hours due to SE-CRF; 4) pH greater than 7.34; 5) respiratory rate (RR) less than or equal to 30 breaths/min.
Exclusion criteria
Patients will be excluded if they meet one or more of the following criteria: 1. refusal of patient's consent; 2. Hemodynamic instability, as defined by a systolic blood pressure < 90 mmHg despite volemic optimizationn, or use of vasoactive agents, i.e. vasopressin or epinephrine at any dosage, norepinephrine > 0.2 mcg/kg/min, dopamine or dobutamine > 5 mcg/kg/min; 3. major cardiac arrhythmia or electrographic signs of ischemia; 4. use of accessory muscles with dyspnoea; 5. pregnancy. The protocol will be interrupted if: 1. agitation or mental status alteration 2. increase use of accessory muscles and/or dyspnoea 3. pH < 7.30 4. systolic blood pressure < 90 mmHg 5. onset of new cardiac arrhythmia