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

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.

Patients who become very unwell may require help from a breathing machine. This requires the patient to be given drugs to put them to sleep (sedation) and have a tube placed through their mouth directly into the windpipe (tube ventilation). This can be life-saving, but may cause harm if used for long periods of time. Non-invasive ventilation (mask ventilation) provides breathing support through a mask that covers the face. Mask ventilation has several advantages over tube ventilation, such as less need for sedation, and it enables the patient to cough and communicate. In previous studies, switching patients from tube to mask ventilation when they start to get better seemed to improve survival rates and reduce complications. The Breathe trial tested if using a protocol to remove tube ventilation and replace it with mask ventilation is better than continuing with tube ventilation until the patient no longer needs breathing machine support. The trial recruited 364 patients. Half of these patients were randomly selected to have the tube removed and replaced with mask ventilation and half were randomly selected to continue with tube ventilation until they no longer needed breathing machine support. The mask group spent 3 fewer days receiving tube ventilation, although the overall time needing breathing machine help (mask and tube) did not change. Fewer patients in the mask group needed antibiotics for chest infections. After removing the tube, twice as many patients needed the tube again in the mask group as in the tube group. There were no differences between the groups in the number of adverse (harm) events or the number of patients who survived to leave hospital. Mask ventilation was no more expensive than tube ventilation. In conclusion, mask ventilation may be an effective alternative to continued tube ventilation when patients start to get better in intensive care.

Relaxation for Critically ill Patient Outcomes and Stress-coping Enhancement (REPOSE): a protocol for a pilot randomised trial of an integrative intervention to improve critically ill patients' delirium and related outcomes.

INTRODUCTION: Delirium is a common complication of critical illness, associated with negative patient outcomes. Preventive or therapeutic interventions are mostly ineffective. Although relaxation-inducing approaches may benefit critically ill patients, no well-designed studies target delirium prevention as a primary outcome. The objective of this study is to assess feasibility and treatment effect estimates of a multimodal integrative intervention incorporating relaxation, guided imagery and moderate pressure touch massage for prevention of critical illness delirium and for related outcomes. METHODS AND ANALYSIS: Randomised, controlled, single-blinded trial with two parallel groups (1:1 allocation: intervention and standard care) and stratified randomisation (age (18-64 years and ≥65 years) and presence of trauma) with blocking, involving 104 patients with Intensive Care Delirium Screening Checklist (ICDSC): 0-3 recruited from two academic intensive care units (ICUs). Intervention group participants receive the intervention in addition to standard care for up to five consecutive days (or until transfer/discharge); control group participants receive standard care and a sham intervention. We will assess predefined feasibility outcomes, that is, recruitment rates and protocol adherence. The primary clinical outcome is incidence of delirium (ICDSC ≥4). Secondary outcomes include pain scores, inflammatory biomarkers, heart rate variability, stress and quality of life (6 weeks and 4 months) post-ICU discharge. Feasibility measures will be analysed descriptively, and outcomes will be analysed longitudinally. Estimates of effects will be calculated. ETHICS AND DISSEMINATION: The study has received approval from the Human Research Ethics Board, University of Alberta. Results will inform the design of a future multicentre trial. TRIAL REGISTRATION NUMBER: NCT02905812; Pre-results.

Program of Integrated Care for Patients with Chronic Obstructive Pulmonary Disease and Multiple Comorbidities (PIC COPD+): a randomised controlled trial.

We sought to evaluate the effectiveness of a multi-component, case manager-led exacerbation prevention/management model for reducing emergency department visits. Secondary outcomes included hospitalisation, mortality, health-related quality of life, chronic obstructive pulmonary disease (COPD) severity, COPD self-efficacy, anxiety and depression.Two-centre randomised controlled trial recruiting patients with ≥2 prognostically important COPD-associated comorbidities. We compared our multi-component intervention including individualised care/action plans and telephone consults (12-weekly then 9-monthly) with usual care (both groups). We used zero-inflated Poisson models to examine emergency department visits and hospitalisation; Cox proportional hazard model for mortality.We randomised 470 participants (236 intervention, 234 control). There were no differences in number of emergency department visits or hospital admissions between groups. We detected difference in emergency department visit risk, for those that visited the emergency department, favouring the intervention (RR 0.74, 95% CI 0.63-0.86). Similarly, risk of hospital admission was lower in the intervention group for those requiring hospital admission (RR 0.69, 95% CI 0.54-0.88). Fewer intervention patients died (21 versus 36) (HR 0.56, 95% CI 0.32-0.95). No differences were detected in other secondary outcomes.Our multi-component, case manager-led exacerbation prevention/management model resulted in no difference in emergency department visits, hospital admissions and other secondary outcomes. Estimated risk of death (intervention) was nearly half that of the control.

Capturing the experiences of patients across multiple complex interventions: a meta-qualitative approach.

OBJECTIVES: The perspectives, needs and preferences of individuals with complex health and social needs can be overlooked in the design of healthcare interventions. This study was designed to provide new insights on patient perspectives drawing from the qualitative evaluation of 5 complex healthcare interventions. SETTING: Patients and their caregivers were recruited from 5 interventions based in primary, hospital and community care in Ontario, Canada. PARTICIPANTS: We included 62 interviews from 44 patients and 18 non-clinical caregivers. INTERVENTION: Our team analysed the transcripts from 5 distinct projects. This approach to qualitative meta-evaluation identifies common issues described by a diverse group of patients, therefore providing potential insights into systems issues. OUTCOME MEASURES: This study is a secondary analysis of qualitative data; therefore, no outcome measures were identified. RESULTS: We identified 5 broad themes that capture the patients' experience and highlight issues that might not be adequately addressed in complex interventions. In our study, we found that: (1) the emergency department is the unavoidable point of care; (2) patients and caregivers are part of complex and variable family systems; (3) non-medical issues mediate patients' experiences of health and healthcare delivery; (4) the unanticipated consequences of complex healthcare interventions are often the most valuable; and (5) patient experiences are shaped by the healthcare discourses on medically complex patients. CONCLUSIONS: Our findings suggest that key assumptions about patients that inform intervention design need to be made explicit in order to build capacity to better understand and support patients with multiple chronic diseases. Across many health systems internationally, multiple models are being implemented simultaneously that may have shared features and target similar patients, and a qualitative meta-evaluation approach, thus offers an opportunity for cumulative learning at a system level in addition to informing intervention design and modification.

Critical care nurses management of prolonged weaning: an interview study.

BACKGROUND: For most critically ill patients requiring mechanical ventilation in the intensive care unit (ICU) weaning is uncomplicated. For the remainder, weaning is a challenge and may result in further complications and increased risk of mortality. Critical care nurses (CCNs) require substantial knowledge and experience to manage patients experiencing prolonged weaning. AIM: The aim of this study was to explore CCNs approach for management of patients experiencing prolonged weaning in the ICU. DESIGN: A descriptive qualitative design. METHODS: Semi-structured interviews with 19 experienced CCNs were conducted. Data were analysed using content analysis. RESULTS: Participants used various strategies for weaning that were grouped into four categories: individualized planning for the weaning process, assessing patient's capacity, managing the process and team interaction. The overall theme that emerged was: CCNs drive the weaning process using both a patient centred and targeted approach. CONCLUSION: CCNs in these ICUs performed weaning using a patient centred approach to plan, initiate, assess and establish a holistic weaning process. Team collaboration among all health care practitioners was important. CCNs have a key role in prioritizing weaning and driving the process forward. RELEVANCE TO CLINICAL PRACTICE: Closeness to the patient and a key role in management of the mechanical ventilated patient in ICU gives the CCN unique potential to develop and create models and tools for prolonged weaning. These tools, specially designed for patients undergoing prolonged weaning, would give focus on continuous planning, collaborating, managing and evaluation in the process of liberating patients from mechanical ventilation.

In pursuit of a holistic learning environment: the impact of music in the medical physiology classroom.

A holistic learning environment is one that nurtures all aspects of students' learning. The environment is safe, supportive, and provides opportunities to help students deal with nonacademic as well as academic factors that impact their learning. Creation of such an environment requires the establishment of a supportive learning community. For a variety of reasons, establishing such a learning community of first-year medical students can be challenging. This communication presents one approach to meeting this challenge in a medical school Human Physiology course. Steps were taken at the beginning of the course to create the community, and activities designed to reinforce these efforts were incorporated into the course as it progressed. Two pilot studies were conducted to test the hypothesis that providing students with a participatory music experience may help to promote a holistic learning environment by helping them restore a sense of balance to their emotional well-being as well as reinforce a sense of community in the classroom. Student response to these activities indicated that these efforts provided emotional support during stressful periods during the quarter, helped promote a feeling of safety within the environment, and re-energized the class during long class sessions. This project illustrates that each instructor, within the confines of his/her own classroom, can make a significant contribution to achieving a holistic learning environment for his/her students.