EXtubation related complications- an international observational study To Understand the impact and BEst practices in the operating room and intensive care unit (EXTUBE Study)

Globally, it is estimated that over 200 million people each year require mechanical ventilation using an endotracheal tube, as part of general anesthesia for surgery or as a life saving intervention in critical illnesses (for example, in severe respiratory failure due to pneumonia). Once a patient has recovered, the endotracheal tube is removed, a process called ‘extubation’. While routinely performed, extubation is a skilled and potentially high risk procedure that should be performed only when physiologic, pharmacologic, and contextual conditions are optimal. The decision of when and how to extubate a patient can be challenging because optimizing certain conditions can antagonize others. For example, extubation while the patient is fully anesthetized before upper airway reflexes return prevents laryngospasm but increases the risk of aspiration. Complications at this stage of patient care can result in decreased oxygen delivery to the brain and body, sometimes leading to serious adverse events such as cardiac arrest, brain damage, or death. Indeed, in audits and safety reports, one quarter of airway complications that result in death or brain death occur at the time of extubation. Each of the last 5 semi annual safety bulletins of critical care incidents in England report serious adverse complications of extubation resulting in patients’ death. In all these cases, the experts’ opinion reflected that these complications could have been prevented with proper planning and timing, adequate techniques and expertise at the bedside.

Despite the frequency of extubation and the potential for life threatening complications of extubation failure, we currently lack systematic data on the rate and circumstances under which these severe complications occur. The limited data on complication rates indicate 30% of extubations may lead to severe complications, de pending on the population and outcome definition. However, the certainty of these estimates is severely limited because they are based on studies that are small, 11 mostly single centre, based on clinician recall, only capture a small portion of extubation complications, or do not reflect current clinical practice. Beyond these data, extubation complications and practices have not been thoroughly studied Yet extubation management decisions and outcomes depend on a complex interplay of patien t and situational characteristics so a large, systematic study would be required to make conclusions about the best extubation technique in various patient populations and settings. Historically, extubation has received significantly less research attention than intubation (i.e the process of inserting the endotracheal tube at the start of mechanical ventilation), even though complications at extubation may occur as frequently as complications at intubation, but may have increased risk of severe patient harm.

Promisingly, a recent focus on intubation complications, risk factors, and best practices has decreased intubation related complications an evidence based bundle of intubation strategies decreased airway complications by 26% suggesting that a similar program of research focusing on extubation could have a comparable impact on patient safety and outcomes. As a result, there have been calls for research to identify risks of extubation complications and effective extubation techniques. In particular, high quality baseline data on complication rates are needed to evaluate future interventions and clinical practice guidelines. High quality data on patient risk factors for complications are needed because current guidelines specify that extubation algorithms should be selected based on patient risk level, but risk factors to date are based mainly on expert opinion. The algorithms themselves are based on case studies and expert opinion as there has been no large scale study of the effectiveness of individual extubation techniques or guidelines, so procedural factors associated with complications need to be elucidated. While adherence to clinical practice guidelines has not been formally evaluated, surveys of anesthesiology and critical care professionals show non adherence to some best practices and considerable variation in practice Lack of adherence to best practices is frequently at the root cause of serious adverse outcomes of extubation, according to data from audits and medicolegal claims, suggesting that half of the complications are preventable For example, half of adverse events associated with extubation in a large audit had evidence of poor planning Therefore, data on the frequency and nature of extubation complications, patient and procedural risk factors for complications, and guideline adherence rates are needed before these preventable events can be addressed. We propose the EXTUBE study, the first systematic, large, international prospective cohort study evaluating the incidence, risk factors, and outcomes of extubation related complications and describing clinical practices related to extubation. We will use an innovative, point prevalence design that we recently adopted to successfully conduct the INTUBE study the largest ever study on endotracheal intubation in critically ill patients. These data will provide a precise understand ing of current extubation practices and associated complications, and will be fundamental in informing targeted interventions to improve patient safety.