Phase
Condition
Lung Injury
Respiratory Failure
Acute Respiratory Distress Syndrome (Ards)
Treatment
N/AClinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
To be eligible, patients had to meet all of the following criteria:
Age ≥ 18 years.
The presence of ≥ 1 among the following factors to define the high-risk for re-intubation: age older than 65 years; heart failure as the primary indication for mechanical ventilation; moderate to severe chronic obstructive pulmonary disease (COPD); an Acute Physiology and Chronic Health Evaluation II (APACHE II) score higher than 12 on extubation day; body mass index of more than 30; inadequate cough reflex or suctioning >2 times within 8 hours before extubation; prolonged use of invasive ventilation (≥ 7 days from the first SBT); more than 2 comorbidities categorized based on the Charlson Comorbidity Index.
Deemed ready to be weaned from the ventilator, based on the following criteria: (a) invasive mechanical ventilation for more than 48 hours, including at least 12 hours of pressure support ventilation with PEEP ≤ 8 cmH2O and pressure support ≤ 10 cmH2O; (b) Improvement of the condition leading to intubation; (c) patient making inspiratory effort; (d) adequate gas exchange, as indicated by a ratio of partial pressure of arterial oxygen (PaO2) to inspiratory fraction of oxygen (FiO2) ≥ 150 with FiO2 ≤ 40% and arterial pH within normal range (7.30 - 7.50); (e) Glasgow Coma Score higher than 13; (f) a core temperature below 38°C; (g) Richmond agitation and sedation scale between -1 and +1.
Eligibility required readiness for scheduled extubation after successfully completing a 30-minute SBT in the pressure-support mode (7 cmH₂O)
SBT success was defined by the following criteria [19]: (a) adequate gas exchange, as indicated by a ratio of partial pressure of arterial oxygen (PaO2) to inspiratory fraction of oxygen (FiO2) ≥ 150 with FiO2 ≤ 40% and arterial pH within the normal range (7.30 - 7.50); (b) respiratory rate < 35/min; (c) spontaneous tidal volume higher than 5 ml of predicted body weight (PBW); (d) a ratio of respiratory rate to tidal volume (i.e. the rapid shallow breathing index, RSBI) < 105/min per liter; (e) systolic blood pressure between 90 and 160 mmHg and heart rate < 140/min, with or without low doses of vasopressors (< 0.5 mcg/kg/min). Exclusion criteria were tracheostomy, patients undergoing withdrawal of life-sustaining treatments, known neuromuscular diseases.
Study Design
Connect with a study center
Azienda Ospedaliero Universitaria Policlinico
Bari, 70124
ItalySite Not Available
Salvatore Grasso
Bari, 70124
ItalySite Not Available
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