None listed
Conditions
Brief summary
Although mechanical ventilation is a life-saving treatment, endotracheal intubation is the most important risk factor for nosocomial pneumonia and increases patients’ discomfort and need for sedatives, which increases in turn the time spent on mechanical ventilation and intensive care unit length of stay. Non-invasive ventilation (NIV) may be used (1) to prevent the occurrence of impending (but not established) acute or post-extubation failure, (2) at an early stage, when respiratory failure is already established, to avert the need for endotracheal intubation, and (3) as an alternative to invasive ventilation at a more advanced stage of acute respiratory failure or to facilitate the process of weaning from mechanical ventilation. No controlled randomized study, however has so far investigated the potential role of NIV in the weaning process of patients with acute lung injury (ALI). The aim of the present study is to investigate whether early extubation followed by NIV application (intervention group) may reduce the ICU length of stay as compared to conventional weaning in patients with hypoxemic acute respiratory failure secondary to ALI or acute respiratory distress syndrome(ARDS). We will performed a prospective randomized multicentre controlled trial. One-hundred-ten patients with ALI will be randomize to receive weaning via early extubation followed by NIV application (intervention group) or via endotracheal tube in place (control group). We expect to find that NIV application by well-experienced centers, will reduce the ICU length of stay as compared with the traditional weaning process via endotracheal tube.
Interventions
Non invasive ventilation (NIV) will be applied through a helmet, which is a transparent latex-free polyvinylchloride hood, or by mask. The ventilator will be set with the same positive end expiratory pressure (PEEP) and inspiratory support applied to the patient before extubation. During the first 24 hours, NIV will be maintained continuously. Thereafter brief discontinuation (less than 5min) will be tolerated for nursing the patients (face, oral hygiene) or to change the non invasive interface.
Non invasive ventilation (NIV) will be applied through a helmet, which is a transparent latex-free polyvinylchloride hood, or by mask. The ventilator will be set with the same positive end expiratory pressure (PEEP) and inspiratory support applied to the patient before extubation. During the first 24 hours, NIV will be maintained continuously. Thereafter brief discontinuation (less than 5min) will be tolerated for nursing the patients (face, oral hygiene) or to change the non invasive interface. To enhance patient tolerance to NIV, a mild sedation with low doses of remifentanyl (0.025-0.15 microg/kg/min) and/or clonidine (bolus 1 microg/kg/min, than 0.003-0.01 microg/kg/min, max 750-900 microg/die) and/or propofol (10-50 mg/hr) will be allowed. Alternation of interfaces (helmet and mask) will also be accepted during the study period to increase patient tolerance. PEEP will be reduced by 2 cmH2O per hour whenever the PaO2/FiO2 ratio will exceed 225, to a minimum level of 8 cmH2O. No decrease in PEEP will be undertaken if PaO2/FiO2 ratio is below 225. In this case, the attendant physician will re-evaluate the patient after 6 hours. Inspiratory support will be reduced by 2 cmH2O per hour to maintain PaCO2 <= 50 mmHg and pH >= 7.35, to a minimum level of 10 cmH2O. When NIV is set at the minimum levels of PEEP and inspiratory support (8 cmH2O and 10 cmH2O, respectively) and the PaO2/FiO2 is higher than 250, a 30-minute spontaneous breathing trial (SBT) with a Venturi mask 35% will be attempted. The SBT will be interrupted and NIV resumed in case of severe dyspnea, activation of accessory muscles, and paradoxical abdominal motion, respiratory rate (RR) > 30 breaths/min, SpO2 < 90%. At the end of the trial an arterial blood gas analysis will be performed: the patients will be considered successfully weaned off NIV if pH >= 7.35, PaCO2 <= 50 mmHg and PaO2 >= 70 mmHg. The total duration of NIV treatment will depend on how quick, according to the established algorithm, will be the weaning process and it can vary on a case by case basis.
Sponsors
Navalesi Paolo
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Invasive mechanical ventilation duration > 48 hours; PaO2/FiO2 ranging between 200 and 300 with a positive end-expiratory pressure PEEP > 8 and < = 12 cmH2O and a FiO2 <= 0.6; Pressure Support Ventilation (PSV) with a total applied pressure (i.e. PEEP + inspiratory support) <= 25 cmH2O; PaCO2 <= 50 mmHg; pH >= 7.35; Respiratory rate (RR) <= 30/min; Core body temperature <= 38.5 (degrees celsius); Glasgow Coma Scale (GCS) >= 10; Presence of clearly audible cough during suctioning; Tracheal suctioning<= 2/hr
Exclusion criteria
Severe hemodynamic instability as assessed: a) systolic arterial pressure < 90 mmHg, despite adequate filling, b) need for continuous infusion of epinephrine, norepinephrine or vasopressine, c) need for dopamine or dobutamine > 5microg/Kg/min Life-threatening arrhythmias or ECG signs of ischemia; Severe sepsis or septic shock; ARF secondary to congestive heart failure, neurological disorders, status asmaticus, chronic obstructive pulmonary disease; Tracheotomy; Copious secretions or uncontrolled vomiting; Spinal cord injury or neuro-muscular disorder; Presence of 2 or more criteria of organ failure; Body mass index >= 30; Obstructive sleep apnea syndrome
Outcome results
None listed