None listed
Conditions
Brief summary
Chest trauma is a common event and may lead to respiratory failure due to several mechanism such as lung contusion and rib fractures. The respiratory failure may create the need for intubation and mechanical ventilation and long stay in intensiva care unit. Non invasive ventilation is form of ventilation delivered by non invasive devices different from endotracheal tubes. It may help patients with respiratory failure, especially less severe forms. High flow nasal therapy is a form of respiratory support that uses high flow of oxygen-air mixture delivered via nasal cannulas. This therapy is useful in less severe forms of respiratory failure or to prevent its incidence or worsening. Rationale: The sequential use of Non invasive ventilation and High flow nasal therapy to facilitate discontinuation of mechanical ventilation in chest trauma patients with acute hypoxemic respiratory failure (hypoxemic ARF) has never been explored. Aim: This study will aim to assess the feasibility and safety of early extubation followed by immediate sequential use of non invasive ventilation and high flow nasal therapy.
Interventions
Sequential use of Non-invasive ventilation (NIV) and High flow nasal therapy.
After inclusion, subjects will be treated successively first with a 2-h session of NIV then with a 1-h session of HFNT. Sequential application of these 2 treatments will be repeated to deliver 16h of NIV and 8 h of HFNT per day.
The intervention will be administered by treating doctors.
The intervention will be modulated as following: PEEP and Pressure support (PS) will be decreased by 2 cmH2O each if after 2 h on
Sequential use of Non-invasive ventilation (NIV) and High flow nasal therapy. After inclusion, subjects will be treated successively first with a 2-h session of NIV then with a 1-h session of HFNT. Sequential application of these 2 treatments will be repeated to deliver 16h of NIV and 8 h of HFNT per day. The intervention will be administered by treating doctors. The intervention will be modulated as following: PEEP and Pressure support (PS) will be decreased by 2 cmH2O each if after 2 h on NIV when PaO2/FiO2 will exceeded 250mmHg till a minimum of 5 and 8 cmH2O. At this time patient will be switched to HFNT only. HFNT will be interrupted if at the end of the all the following occurred: pH >7.35, PaCO2 < 45mmHg and PaO2 > 70 mmHg, RR < 30 breaths/min, absence of dyspnoea, respiratory accessory muscles recruitment, and paradoxical abdominal motion during 30-min spontaneous breathing trial (SBT) with oxygen supplementation through a Venturi mask at a FiO2 of 0.35. The HFNT device (Optiflow, Fisher & Paykel Healthcare, Auckland, New Zealand) includes a venturi air-oxygen blender, which allows the accurate adjustment of FiO2 between 0.30 and 1.0 and delivery of gas flow up to 60 L/min through a heated humidifier (MR850, Fisher & Paykel Healthcare). The gas mixture will be routed through a circuit to the subject at a temperature of 37 degree Celtius and an absolute humidity of 44 mg/L via large-bore bi-nasal prongs. HFNC was initially administered at a gas flow of 60 L/min and a FIO2 of 1.0. FIO2 will be adjusted to maintain a SpO2 > 92%. NIV will be delivered to the subject in a semi recumbent position with a full-face mask (Fisher & Paykel Healthcare) connected to an ICU ventilator with a dedicated NIV mode (Evita 2 Dura-Drager Lubeck- Germany) equipped with a heated humidifier (Kendall Aerodyne Ultratherm). Full-face and oronasal masks will be utilized in rotation, to improve patient tolerance to NIV, as indicated. Subjects will be ventilated by NIV at the same support used before extubation. After that pressure support level will be targeted to an expired tidal volume of 7-8 mL/kg, PaCO2 < 45 mmHg, a pH >7.35 and RR< 30/breaths/min. PEEP will be adjusted to maintain PaO2/FiO2 ratio > 225. In the case PaO2/FiO2 will be less than 200 mmHg during NIV, PEEP will be increased to reach the target of 225 mmHg and left at that level for next three NIV rounds before reattempting its reduction. In the case PaO2/FiO2 will be less than 225 mmHg and at least 200 mmHg during HFNT NIV will be reassumed for 2 hours before restarting HFNT. Duration of the intervention: PEEP and PS will be decreased by 2 cmH2O each if after 2 hours on NIV when PaO2/FiO2 will exceeded 250mmHg till a minimum of 5 and 8 cmH2O. At this time patient will be switched to HFNT only. HFNT will be interrupted if at the end of the all the following parameters will occur: pH >7.35, PaCO2 < 45mmHg and PaO2 > 70 mmHg, RR < 30 breaths/min, absence of dyspnoea, respiratory accessory muscles recruitment, and paradoxical abdominal motion during 30-min spontaneous breathing trial (SBT) with oxygen supplementation through a Venturi mask at a FiO2 of 0.35.
Sponsors
University of Palermo. Pocliclinico P. Giaccone
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All of the following: 1) age equal or higher than 18 years; 2) Invasive Mechanical Ventilation (iMV) for at least 24h; 3) pressure support ventilation (PSV) with a total applied pressure, i.e. positive end-expiratory pressure (PEEP) inspiratory support, < 20 cmH2O and a PEEP level between 8 and 10 cmH2O; 4) PaO2/FiO2 between 200 and 300 mmHg 5) PaCO2 < 45mmHg and pH > 7.35; 6) respiratory rate (RR) < 30/min; 7) core temperature < 38.5 degree Celtius; (8) 8) Glasgow coma scale (GCS) equal or higher than 11; 9) Richmond Agitation Sedation Score < 3; 10) cough on suctioning and need for tracheobronchial suctioning less than 2 per hour.
Exclusion criteria
One of the following: 1) hemodynamic instability i.e. systolic arterial pressure < 90 mmHg despite fluid repletion; 2) use of vasoactive agents, i.e. vasopressin, epinephrine and norepinephrine at any dosage, and dopamine or dobutamine > 5mcg/kg/min; 3) life-threatening arrhythmias or electrocardiographic signs of ischemia; 4) sepsis or septic shock; 5) ARF secondary to neurological disorders, status asthmaticus, COPD, cardiogenic pulmonary oedema; 6) presence of tracheotomy; 7) uncontrolled vomiting; 8) uncontrolled agitation RASS >3 5; 9) two or more organ failures; 10) body mass index > 30; 11) documented history or suspicion of obstructive sleep apnoea; 12) unstable flail chest 13) recent upper airway or esophageal surgery 14) ongoing pregnancy 15) inclusion in other research protocols.
Outcome results
None listed