Trials
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Randomized Controlled Trial Multicenter Study Comparative Study
Different strategies for mechanical VENTilation during CardioPulmonary Bypass (CPBVENT 2014): study protocol for a randomized controlled trial.
There is no consensus on which lung-protective strategies should be used in cardiac surgery patients. Sparse and small randomized clinical and animal trials suggest that maintaining mechanical ventilation during cardiopulmonary bypass is protective on the lungs. Unfortunately, such evidence is weak as it comes from surrogate and minor clinical endpoints mainly limited to elective coronary surgery. According to the available data in the academic literature, an unquestionable standardized strategy of lung protection during cardiopulmonary bypass cannot be recommended. The purpose of the CPBVENT study is to investigate the effectiveness of different strategies of mechanical ventilation during cardiopulmonary bypass on postoperative pulmonary function and complications. ⋯ The CPBVENT trial will establish whether, and how, different ventilator strategies during cardiopulmonary bypass will have an impact on postoperative pulmonary complications and outcomes of patients undergoing cardiac surgery.
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Multicenter Study
Impact of community-initiated Kangaroo Mother Care on survival of low birth weight infants: study protocol for a randomized controlled trial.
Around 70% neonatal deaths occur in low birth weight (LBW) babies. Globally, 15% of babies are born with LBW. Kangaroo Mother Care (KMC) appears to be an effective way to reduce mortality and morbidity among LBW babies. KMC comprises of early and continuous skin-to-skin contact between mother and baby as well as exclusive breastfeeding. Evidence derived from hospital-based studies shows that KMC results in a 40% relative reduction in mortality, a 58% relative reduction in the risk of nosocomial infections or sepsis, shorter hospital stay, and a lower risk of lower respiratory tract infections in babies with birth weight <2000 g. There has been considerable interest in KMC initiated outside health facilities for LBW babies born at home or discharged early. Currently, there is insufficient evidence to support initiation of KMC in the community (cKMC). Formative research in our study setting, where 24% of babies are born with LBW, demonstrated that KMC is feasible and acceptable when initiated at home for LBW babies. The aim of this trial is to determine the impact of cKMC on the survival of these babies. ⋯ This efficacy trial will answer the question whether the benefits of KMC observed in hospital settings can also be observed when KMC is started in the community. The formative research used for intervention development suggests that the necessary high level of KMC adoption can be reached in the community, addressing a problem that seriously constrained conclusions in the only other trial in which researchers examined the benefits of cKMC.
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Randomized Controlled Trial Multicenter Study
Fatigue mitigation with SleepTrackTXT2 in air medical emergency care systems: study protocol for a randomized controlled trial.
Most air medical Emergency Medical Services (EMS) clinicians work extended duration shifts, and more than 50% report inadequate sleep, poor sleep quality, and/or poor recovery between shifts. The SleepTrackTXT pilot trial (ClinicalTrials.gov, NCT02063737) showed that use of mobile phone text messages could impact EMS clinician self-reported fatigue and sleepiness during long duration shifts. The purpose of the SleepTrackTXT2 trial is to leverage lessons learned from the first SleepTrackTXT study and test an enhanced intervention targeting air medical EMS clinicians. ⋯ The SleepTrackTXT2 trial may provide evidence of real-world effectiveness that would support widespread expansion of fatigue mitigation interventions in emergency care clinician shift workers. The trial may specifically support use of real-time assessments and interventions delivered via mobile technology such as text messaging.
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Randomized Controlled Trial
Influences of De Qi induced by acupuncture on immediate and accumulated analgesic effects in patients with knee osteoarthritis: study protocol for a randomized controlled trial.
De Qi is a special sensational response upon acupuncture needling. According to traditional acupuncture theory, the treatment is "effective only after Qi arrival"; that is, De Qi is an important indicator of therapeutic efficacy and good prognosis. However, it is still disputable whether De Qi improves the efficacy of acupuncture therapy. This prospective, randomized controlled trial aims to explore the influence of De Qi induced by acupuncture on immediate and accumulated analgesic effects in patients with knee osteoarthritis (KOA). ⋯ This prospective randomized controlled study will be helpful in enhancing our understanding of the analgesic effect of De Qi on patients with KOA and may provide a clinical basis for further investigation of the relationship between De Qi and the therapeutic efficacy of acupuncture, thereby offering some evidence for the role of De Qi in an efficacious acupuncture therapy.
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Randomized Controlled Trial Multicenter Study Comparative Study
Live birth after fresh versus frozen single blastocyst transfer (Frefro-blastocyst): study protocol for a randomized controlled trial.
Multiple pregnancies are one of the major safety concerns of in vitro fertilization (IVF) due to the increased risk of maternal and neonatal complications. Single embryo transfer is the most effective way to reduce the risk of multiple pregnancies. Selection of the embryo and optimization of the implantation environment are crucial to retain the success rate when the number of transferred embryos is diminished. Fresh embryo transfer with supra-physiological levels of hormones has been suggested to have an adverse effect on implantation. Elective frozen embryo transfer has been suggested to result in a higher rate of live birth than fresh embryo transfer. However, there is still a lack of evidence from randomized clinical trials comparing the efficacy and safety between frozen and fresh single blastocyst transfers. ⋯ The results of this study will provide evidence for the efficacy and safety of the strategy of elective frozen single blastocyst transfer in women with a good prognosis.