Prospective randomised trial of the Integrated Pulmonary Index™ in low-acuity inpatients.
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ABSTRACT:
SUBMITTER: Freundlich RE
PROVIDER: S-EPMC6972229 | biostudies-literature | 2018 Dec
REPOSITORIES: biostudies-literature
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Prospective randomised trial of the Integrated Pulmonary Index™ in low-acuity inpatients.
Freundlich R E RE Walco J P JP Mueller D M DM Wanderer J P JP Rothman B S BS Shotwell M S MS Sandberg W S WS Pandharipande P P PP Weavind L M LM
British journal of anaesthesia 20181009 6
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Project description:BackgroundChronic pain can disrupt the cortical representation of a painful body part. This disruption may play a role in maintaining the individual's pain. Tactile acuity training has been used to normalise cortical representation and reduce pain in certain pain conditions. However, there is little evidence for the effectiveness of this intervention for chronic low back pain (CLBP). The primary aim of this study was to inform the development of a fully powered randomised controlled trial (RCT) by providing preliminary data on the effect of tactile acuity training on pain and function in individuals with CLBP. The secondary aim was to obtain qualitative feedback about the intervention.MethodsIn this mixed-methods pilot RCT 15 individuals were randomised to either an intervention (tactile acuity training) or a placebo group (sham tactile acuity training). All participants received 3 sessions of acuity training (intervention or sham) from a physiotherapist and were requested to undertake daily acuity home training facilitated by an informal carer (friend/relative). All participants also received usual care physiotherapy. The primary outcome measures were pain (0-100visual analogue scale (VAS)) and function (Roland Morris Disability Questionnaire (RMDQ)). Participants and their informal carers were invited to a focus group to provide feedback on the intervention.ResultsThe placebo group improved by the greatest magnitude for both outcome measures, but there was no statistically significant difference (Mean difference (95%CI), p-value) between groups for change in pain (25.6 (-0.7 to 51.9), p = 0.056) or function (2.2 (-1.6 to 6.0), p = 0.237). Comparing the number of individuals achieving a minimally clinically significant improvement, the placebo group had better outcomes for pain with all participants achieving ?30% improvement compared to only a third of the intervention group (6/6 vs. 3/9, p = 0.036). Qualitatively, participants reported that needing an informal carer was a considerable barrier to the home training component of the study.ConclusionsThis pilot RCT found tactile acuity training to be no more effective than sham tactile acuity training for function and less effective for pain in individuals with CLBP. That the intervention could not be self-applied was a considerable barrier to its use.Trial registration isrctnISRCTN98118082.
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Project description:Thunderbeat™ is a device that uses both ultrasonic and advanced bipolar energies to achieve hemostasis. It has been evaluated in a variety of clinical contexts, but no literature exists regarding its application to pancreatic surgery. Using a prospective, randomized controlled trial, we evaluated its safety and efficacy in the Whipple procedure. Thirty-two participants were enrolled in the study. The Thunderbeat™ device during the Whipple procedure showed similar safety profile compared to standard of care.
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Project description: Not available
| S-EPMC9524622 | biostudies-literature
Project description:BACKGROUND:The intubating laryngeal mask Fastrach™ is considered a gold standard for blind intubation as well as for fibreoptic guided intubation via a laryngeal mask. Recently, a single use version of the mask has been introduced. We compared the Fastrach single use with the new, low-priced single use intubating laryngeal mask Ambu Aura-i™. We hypothesised that the LMA Ambu Aura-i and the LMA Fastrach are comparable with respect to success rates for mask placement and blind tracheal intubation through the LMA device. METHODS:A prospective, randomised clinical trial. University Hospital Schleswig-Holstein, Campus Kiel, from April 2011 to April 2012. Eighty patients undergoing general anaesthesia with planned tracheal intubation were randomised and enrolled in the study. Blind intubation was performed with either laryngeal mask using two different tracheal tubes (Rüsch Super Safety Silk™ and LMA ETT™). A crossover-design was performed after an unsuccessful procedure. Primary outcome measure was the overall success rate of blind intubation. Secondary outcome measures were the time to the first adequate ventilation, a subjective handling score, and a fibreoptic control of placement, as well as the success rate of mask placement, time for mask removal after successful intubation, differences in airway leak pressure, and the incidence of postoperative sore throat and hoarseness. RESULTS:The success rate of tracheal intubation with the Fastrach for the first and second attempt was significantly better compared with the Ambu Aura-i. Tracheal intubation was also significantly faster (14.1 s. ±4.4 versus 21.3 s. ±9.0; p < 0.01), and the time interval for mask removal after successful intubation was significantly shorter using the Fastrach device (24.0 s. ±8.2 versus 29.4 s. ±7.5; p < 0.001). There were no significant differences between groups regarding the incidence of postoperative sore throat and hoarseness. CONCLUSION:Both laryngeal mask devices are suitable for ventilation and oxygenation. Blind intubation remains the domain of the LMA Fastrach, the Ambu Aura-i is not suitable for blind intubation. TRIAL REGISTRATION:Clinicaltrials.gov Identification Number NCT03109678 , retrospectively registered on April 12, 2017.
| S-EPMC6441151 | biostudies-literature
Project description:BackgroundThe Supreme™ and ProSeal™ laryngeal mask airways (LMAs) are widely used in paediatric anaesthesia; however, LMA use in infants is limited because many anaesthesiologists prefer to use tracheal intubation in infants. In this study, we compared the Supreme and ProSeal LMAs in infants by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in haemodynamics and rates of postoperative complications.MethodsInfants of ASA physical status I scheduled for elective, minor, lower abdominal surgery were divided into two groups: the Supreme LMA group and the ProSeal LMA group. Times and ease of LMA insertion were noted. The percentages of tidal volume leakage as well as peak, mean and leakage pressures for all infants were measured. Heart rate (HR), oxygen saturation (SpO2) and end tidal carbon dioxide (EtCO2) values were recorded before and after LMA insertion and before and after extubation. After extubation, complications and adverse effects were noted.ResultsDemographic and surgical data were similar between the two groups. LMA insertion times were shorter for the ProSeal group than for the Supreme group (P < 0.002). The mean HR value for the ProSeal group was lower than for the Supreme group (P < 0.011). Both the peak pressure and the leakage percentage for the ProSeal group were statistically lower than for the Supreme group. The leakage pressure for the ProSeal group was statistically higher than for the Supreme group (P < 0.001).ConclusionsThe ProSeal LMA is superior to the Supreme LMA for use in infants due to the ease of insertion, high oropharyngeal leakage pressure and fewer induced changes in haemodynamics.Trial registrationClinicalTrial.gov, NCT03251105 , retrospectively registered on 15 Aug 2017.
| S-EPMC5584514 | biostudies-literature
Project description:ObjectiveTo determine if a low glycaemic index diet in pregnancy could reduce the incidence of macrosomia in an at risk group.DesignRandomised controlled trial.SettingMaternity hospital in Dublin, Ireland.Participants800 women without diabetes, all in their second pregnancy between January 2007 to January 2011, having previously delivered an infant weighing greater than 4 kg.InterventionWomen were randomised to receive no dietary intervention or start on a low glycaemic index diet from early pregnancy.Main outcomesThe primary outcome measure was difference in birth weight. The secondary outcome measure was difference in gestational weight gain.ResultsNo significant difference was seen between the two groups in absolute birth weight, birthweight centile, or ponderal index. Significantly less gestational weight gain occurred in women in the intervention arm (12.2 v 13.7 kg; mean difference -1.3, 95% confidence interval -2.4 to -0.2; P=0.01). The rate of glucose intolerance was also lower in the intervention arm: 21% (67/320) compared with 28% (100/352) of controls had a fasting glucose of 5.1 mmol/L or greater or a 1 hour glucose challenge test result of greater than 7.8 mmol/L (P=0.02).ConclusionA low glycaemic index diet in pregnancy did not reduce the incidence of large for gestational age infants in a group at risk of fetal macrosomia. It did, however, have a significant positive effect on gestational weight gain and maternal glucose intolerance.Trial registrationCurrent Controlled Trials ISRCTN54392969.
| S-EPMC3431285 | biostudies-literature
Project description:BackgroundThe early warning scores may increase the safety of perioperative period. The objective of this study was to assess the diagnostic and predictive role of Integrated Pulmonary Index (IPI) after off-pump coronary artery bypass grafting (OPCAB).Materials and methodsForty adult patients undergoing elective OPCAB were enrolled into a single-center prospective observational study. We assessed respiratory function using IPI that includes oxygen saturation, end-tidal CO2, respiratory rate, and pulse rate. In addition, we evaluated blood gas analyses and hemodynamics, including ECG, invasive arterial pressure, and cardiac index. The measurements were performed after transfer to the intensive care unit, after spontaneous breathing trial and at 2, 6, 12, and 18 h after extubation.Results and discussionThe value of IPI registered during respiratory support correlated weakly with cardiac index (rho = 0.4; p = 0.04) and ScvO2 (rho = 0.4, p = 0.02). After extubation, IPI values decreased significantly, achieving a minimum by 18 h. The IPI value ≤9 at 6 h after extubation was a predictor of complicated early postoperative period (AUC = 0.71; p = 0.04) observed in 13 patients.ConclusionIn off-pump coronary surgery, the IPI decreases significantly after tracheal extubation and may predict postoperative complications.
| S-EPMC5552677 | biostudies-literature
Project description: Not available
| S-EPMC8332197 | biostudies-literature
Project description:IntroductionWhether medication optimisation improves clinical outcomes in elderly individuals remains unclear. The current study aims to evaluate the effect of multidisciplinary team-based medication optimisation on survival, rehospitalisation and unscheduled hospital visits in elderly patients.Methods and analysisWe report the protocol of a single-centre, open-label, randomised controlled trial. The enrolled subjects will be medical inpatients, aged 65 years or older, admitted to a community hospital and receiving five or more regular medications. The participants will be randomly assigned to receive either an intervention for medication optimisation or the usual care. The intervention will consist of a multidisciplinary team-based medication review, followed by a medication optimisation proposal based on the Screening Tool of Older Persons' potentially inappropriate Prescriptions/Screening Tool to Alert doctors to the Right Treatment criteria and an implicit medication optimisation protocol. Medication optimisation summaries will be sent to primary care physicians and community pharmacists on discharge. The primary outcome will be a composite of death, unscheduled hospital visits and rehospitalisation until 48 weeks after randomisation. Secondary outcomes will include each of the primary endpoints, the number of prescribed medications, quality of life score, level of long-term care required, drug-related adverse events, death during hospitalisation and falls. Participants will be followed up for 48 weeks with bimonthly telephone interviews to assess the primary and secondary outcomes. A log-rank test stratified by randomisation factors will be used to compare the incidence of the composite endpoint. The study was initiated in 2019 and a minimum of 500 patients will be enrolled.Ethics and disseminationThe study protocol has been approved by the Institutional Ethical Committee of St. Marianna University School of Medicine (No. 4129). The results of the current study will be submitted to a peer-reviewed journal.Trial registration numberUMIN000035265.
| S-EPMC7552871 | biostudies-literature
Project description:ObjectiveTo investigate the long term effectiveness of integrated disease management delivered in primary care on quality of life in patients with chronic obstructive pulmonary disease (COPD) compared with usual care.Design24 month, multicentre, pragmatic cluster randomised controlled trialSetting40 general practices in the western part of the NetherlandsParticipantsPatients with COPD according to GOLD (Global Initiative for COPD) criteria. Exclusion criteria were terminal illness, cognitive impairment, alcohol or drug misuse, and inability to fill in Dutch questionnaires. Practices were included if they were willing to create a multidisciplinary COPD team.InterventionGeneral practitioners, practice nurses, and specialised physiotherapists in the intervention group received a two day training course on incorporating integrated disease management in practice, including early recognition of exacerbations and self management, smoking cessation, physiotherapeutic reactivation, optimal diagnosis, and drug adherence. Additionally, the course served as a network platform and collaborating healthcare providers designed an individual practice plan to integrate integrated disease management into daily practice. The control group continued usual care (based on international guidelines).Main outcome measuresThe primary outcome was difference in health status at 12 months, measured by the Clinical COPD Questionnaire (CCQ); quality of life, Medical Research Council dyspnoea, exacerbation related outcomes, self management, physical activity, and level of integrated care (PACIC) were also assessed as secondary outcomes.ResultsOf a total of 1086 patients from 40 clusters, 20 practices (554 patients) were randomly assigned to the intervention group and 20 clusters (532 patients) to the usual care group. No difference was seen between groups in the CCQ at 12 months (mean difference -0.01, 95% confidence interval -0.10 to 0.08; P=0.8). After 12 months, no differences were seen in secondary outcomes between groups, except for the PACIC domain "follow-up/coordination" (indicating improved integration of care) and proportion of physically active patients. Exacerbation rates as well as number of days in hospital did not differ between groups. After 24 months, no differences were seen in outcomes, except for the PACIC follow-up/coordination domain.ConclusionIn this pragmatic study, an integrated disease management approach delivered in primary care showed no additional benefit compared with usual care, except improved level of integrated care and a self reported higher degree of daily activities. The contradictory findings to earlier positive studies could be explained by differences between interventions (provider versus patient targeted), selective reporting of positive trials, or little room for improvement in the already well developed Dutch healthcare system.Trial registrationNetherlands Trial Register NTR2268.
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