Trials
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Although general anaesthesia (GA) with one-lung ventilation is the current standard of care, minor thoracoscopic surgery, i.e. treatment of pleural effusions, biopsies and small peripheral pulmonary wedge resections, can also be performed using local anaesthesia (LA), analgosedation and spontaneous breathing. Whilst the feasibility and safety of LA have been demonstrated, its impact on patient satisfaction remains unclear. Most studies evaluating patient satisfaction lack control groups or do not meet psychometric criteria. We report the design of the PASSAT trial (PAtientS' SATisfaction in thoracic surgery - general vs. local anaesthesia), a randomised controlled trial with a non-randomised side arm. ⋯ The PASSAT study is the first randomised controlled trial to systematically assess patients' satisfaction depending on LA or GA. The study follows an interdisciplinary approach, and its results may also be applicable to other surgical disciplines. It is also the first cost study based on randomised samples. Comparison of the randomised and the non-randomised groups may contribute to satisfaction research.
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Adolescence and young adulthood are critical times of initiation and progression to daily use of tobacco. However, it is difficult to recruit young adults to traditional smoking cessation and retention rates are typically low. Smartphone cessation applications (apps) can provide real-time responses to smoking urges and related cues, which are known to be important factors in lapse and relapse. Given the popularity of smartphones among young adults and the considerably higher download rates of commercially developed apps compared to research-based apps, there is a need to design pragmatic studies that evaluate commercial tobacco cessation apps. The aims of this pilot study are to assess the impact on tobacco cessation of using a smartphone app compared with usual care and to generate feasibility data to inform a future fully powered clinical trial. ⋯ This pilot trial will be the first to evaluate a commercially available smartphone app for tobacco cessation in a hospitalized setting. Data generated by this study can be used for larger fully powered trials such as comparative effectiveness studies against apps developed by academics or health scientists based on behavioral theories, or cost-effectiveness analyses of mobile interventions.
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Postoperative delirium may manifest in the immediate post-anaesthesia care period. Such episodes appear to be predictive of further episodes of inpatient delirium and associated adverse outcomes. Frontal electroencephalogram (EEG) findings of suppression patterns and low proprietary index values have been associated with postoperative delirium and poor outcomes. However, the efficacy of titrating anaesthesia to proprietary index targets for preventing delirium remains contentious. We aim to assess the efficacy of two strategies which we hypothesise could prevent post-anaesthesia care unit (PACU) delirium by maximising the alpha oscillation observed in frontal EEG channels during the maintenance and emergence phases of anaesthesia. ⋯ This is a largely exploratory study; the extent to which EEG signatures can be modified by titration of pharmacological agents is not known. The underlying concept is maximisation of anaesthetic efficacy by individualised drug titration to a clearly defined EEG feature. The interventions are already clinically used strategies in anaesthetic practice, but have not been formally evaluated. The addition of propofol during the emergence phase of volatile-based general anaesthesia is known to reduce emergence delirium in children; however, the efficacy of this strategy in older patients is not known.
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The need for cardiopulmonary resuscitation (CPR) is often unexpected, and the infrequent use of CPR in the delivery room (DR) limits the opportunity to perform rigorous clinical studies to determine the best method for delivering chest compression (CC) to newborn infants. The current neonatal resuscitation guidelines recommend using a coordinated 3:1 compression-to-ventilation (C:V) ratio (CC at a rate of 90/min and ventilations at a rate of 30/min). In comparison, providing CC during a sustained inflation (SI) (CC + SI) significantly improved hemodynamics, minute ventilation, and time to return of spontaneous circulation (ROSC) compared to 3:1 C:V ratio in asphyxiated piglets. Similarly, a small pilot trial in newborn infants showed similar results. Until now no study has examined different CC techniques during neonatal resuscitation in asphyxiated newborn infants in the DR. To date, no trial has been performed to directly compare CC + SI and 3:1 C:V ratio in the DR during CPR of asphyxiated newborn infants. ⋯ Morbidity and mortality rates are extremely high for newborns requiring CC. We believe the combination of simultaneous CC and SI during CPR has the potential to significantly improve ROSC and survival. In addition, we believe that CC + SI might improve respiratory and hemodynamic parameters and potentially minimize morbidity and mortality in newborn infants. In addition, this will be the first randomized controlled trial to examine CC in the newborn period.
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Subclinical hypothyroidism is a common condition in patients with heart failure and is defined as elevated serum thyroid hormone (TSH) with normal circulating free thyroxine (FT4). Evidence on the effect of thyroid hormone treatment is lacking. We designed a randomized controlled trial to compare the efficacy and safety of thyroid hormone supplementation in patients with chronic heart failure complicated with subclinical hypothyroidism. ⋯ ClinicalTrials.gov, NCT03096613 . Registered on 30 March 2017.