Protocolised non-invasive compared with invasive weaning from mechanical ventilation for adults in intensive care: the Breathe RCT

Abstract

Background Invasive mechanical ventilation (IMV) is a life-saving intervention. Following resolution of the condition that necessitated IMV, a spontaneous breathing trial (SBT) is used to determine patient readiness for IMV discontinuation. In patients who fail one or more SBTs, there is uncertainty as to the optimum management strategy. Objective To evaluate the clinical effectiveness and cost-effectiveness of using non-invasive ventilation (NIV) as an intermediate step in the protocolised weaning of patients from IMV. Design Pragmatic, open-label, parallel-group randomised controlled trial, with cost-effectiveness analysis. Setting A total of 51 critical care units across the UK. Participants Adult intensive care patients who had received IMV for at least 48 hours, who were categorised as ready to wean from ventilation, and who failed a SBT. Interventions Control group (invasive weaning): patients continued to receive IMV with daily SBTs. A weaning protocol was used to wean pressure support based on the patient’s condition. Intervention group (non-invasive weaning): patients were extubated to NIV. A weaning protocol was used to wean inspiratory positive airway pressure, based on the patient’s condition. Main outcome measures The primary outcome measure was time to liberation from ventilation. Secondary outcome measures included mortality, duration of IMV, proportion of patients receiving antibiotics for a presumed respiratory infection and health-related quality of life. Results A total of 364 patients (invasive weaning, n = 182; non-invasive weaning, n = 182) were randomised. Groups were well matched at baseline. There was no difference between the invasive weaning and non-invasive weaning groups in median time to liberation from ventilation {invasive weaning 108 hours [interquartile range (IQR) 57–351 hours] vs. non-invasive weaning 104.3 hours [IQR 34.5–297 hours]; hazard ratio 1.1, 95% confidence interval [CI] 0.89 to 1.39; p = 0.352}. There was also no difference in mortality between groups at any time point. Patients in the non-invasive weaning group had fewer IMV days [invasive weaning 4 days (IQR 2–11 days) vs. non-invasive weaning 1 day (IQR 0–7 days); adjusted mean difference –3.1 days, 95% CI –5.75 to –0.51 days]. In addition, fewer non-invasive weaning patients required antibiotics for a respiratory infection [odds ratio (OR) 0.60, 95% CI 0.41 to 1.00; p = 0.048]. A higher proportion of non-invasive weaning patients required reintubation than those in the invasive weaning group (OR 2.00, 95% CI 1.27 to 3.24). The within-trial economic evaluation showed that NIV was associated with a lower net cost and a higher net effect, and was dominant in health economic terms. The probability that NIV was cost-effective was estimated at 0.58 at a cost-effectiveness threshold of £20,000 per quality-adjusted life-year. Conclusions A protocolised non-invasive weaning strategy did not reduce time to liberation from ventilation. However, patients who underwent non-invasive weaning had fewer days requiring IMV and required fewer antibiotics for respiratory infections. Future work In patients who fail a SBT, which factors predict an adverse outcome (reintubation, tracheostomy, death) if extubated and weaned using NIV? Trial registration Current Controlled Trials ISRCTN15635197. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 48. See the NIHR Journals Library website for further project information.

Biosignal-Based Digital Biomarkers for Prediction of Ventilator Weaning Success

“…Although many predictive indices and clinical tools are already in use [1,[13][14][15][16][17][18][19][20][21][22], >20% of the patients who have fulfilled the classic weaning criteria require reintubation [14,[23][24][25]. The predictive performance decreases in patients with multi-organ dysfunction, older age, prolonged MV, and severe illness [26][27][28][29][30][31].…”

Management of pain reduction in mechanically ventilated care subjects

“…Empathy and emotional support play a crucial role in the patient's perception of pain, and nursing staff are vital in ensuring that patients feel heard and understood. (30,31,32,33) In the case of ventilated patients, nursing also faces the additional challenge of limited communication due to intubation and sedation. This requires even more careful observation and assessment to identify any signs of discomfort or pain in the patient.…”

A Predictive Model for Patient Census and Ventilator Requirements at Individual Hospitals During the Coronavirus Disease 2019 (COVID-19) Pandemic: A Preliminary Technical Report

“…The Weibull formula is flexible, as it can be fit to exponential or skewed distributions, depending on the value of the shape parameter [10]. Second, the Weibull distribution is used routinely for estimation of the time to removal of the tracheal tube in patients in intensive care and when undergoing general anesthesia, providing us with estimates of appropriate starting conditions for the shape parameter [11,12]. Third, the Weibull distribution has an analytical conditional distribution function [13].…”