Effect of End-inspiratory Airway Pressure Measurements on the Risk of VILI in Ventilated Patients
NCT05991258
Acute Respiratory Failure, Lung Diseases
Padua, Italy
View Trial DetailsNCT Number: NCT05295186
Spontaneous breathing trials (SBTs) assess readiness for extubation, yet the use of conventional parameters used to establish weaning success may be elusive, especially in high-risk patients. Currently, non-invasive techniques allow comprehensive bedside assessment of advanced respiratory mechanics, including metrics of respiratory system compliance (CRS), respiratory muscle effort (POCC) and respiratory drive intensity (P0.1). This study investigates whether these measurements during SBT may improve the prediction of extubation outcomes
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Notify Me18 year–100 year
All sexes
Observational
Azienda Ospedaliero Universitaria Policlinico, Bari, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
To be eligible, patients had to meet all of the following criteria:
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.
Time frame: 30 minutes
The primary endpoint was to establish whether changes in CRS, POCC and P0.1 and/or their absolute values at the end of the PAV+ SBT differed between patients who subsequently required reintubation vs. those who were successfully extubated
Time frame: 72 hours
we aimed to test the discriminatory power of the absolute values of CRS, POCC and P0.1 at the end of SBT and discriminatory power of the SBT-induced percentage changes in these measurements during the trial in identifying patients who failed extubation.The decision to reintubate was made by the attending physicians, who were unaware of the study measurements results.
University of Bari
Other
Noninvasive Assessment of Respiratory Mechanics, Inspiratory Effort, and Respiratory Drive During Spontaneous Breathing Trial to Predict Extubation Failure in High-Risk Patients
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