Correction to: Induction techniques that reduce redistribution hypothermia: a prospective, randomized, controlled, single blind effectiveness study.
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ABSTRACT:
SUBMITTER: Roth JV
PROVIDER: S-EPMC8040191 | biostudies-literature | 2021 Apr
REPOSITORIES: biostudies-literature
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Correction to: Induction techniques that reduce redistribution hypothermia: a prospective, randomized, controlled, single blind effectiveness study.
Roth Jonathan V JV Braitman Leonard E LE Hunt Lacy H LH
BMC anesthesiology 20210412 1
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Project description:BackgroundWhile much effort has been devoted to correcting intraoperative hypothermia, less attention has been directed to preventing redistribution hypothermia. In this study, we compared three different anesthetic induction techniques to standard IV propofol inductions (control) in their effect on reducing redistribution hypothermia.MethodsElective, afebrile patients, age 18 to 55 years, were randomly assigned to one of four groups (n = 50 each). Group "INH/100" was induced with 8% sevoflurane in 100% oxygen, Group "INH/50" with 8% sevoflurane in 50% oxygen and 50% nitrous oxide, Group "PROP" with 2.2 mg/kg propofol, and Group "Phnl/PROP" with 2.2 mg/kg propofol immediately preceded by 160 mcg phenylephrine. Patients were maintained with sevoflurane in 50% nitrous oxide and 50% oxygen in addition to opioid narcotic. Forced air warming was used. Core temperatures were recorded every 15 min after induction for 1 h.ResultsCompared to control group PROP, the mean temperatures in groups INH/100, INH/50, and Phnl/PROP were higher 15, 30, 45 and 60 min after induction (p < 0.001 for all comparisons), averaging between 0.39 °C and 0.54 °C higher. In group PROP, 60% of patients had at least one temperature below 36.0 °C in the first hour whereas only 16% did in each of groups INH/100, INH/50, and Phnl/PROP (p < 0.0001 in each group compared to PROP).ConclusionsIn this effectiveness trial, inhalation inductions with sevoflurane or with prophylactic phenylephrine bolus prior to propofol induction reduced the magnitude of redistribution hypothermia by an average of 0.4 to 0.5 °C in patients aged 18 to 55 years.Trial registrationRetrospectively registered on clinical-trials.gov as NCT02331108 , November 20, 2014.
| S-EPMC6836364 | biostudies-literature
Project description:IntroductionThe aim of this study was to explore a method to rank the cost-effectiveness of presbyopia correction in diverse strategies of bilateral cataract surgery to provide references for healthcare policymakers in rationalizing resource utilization and surgeons in customizing patient management.MethodsThe cost-effectiveness analysis based on a prospective single-blind two-center clinical trial included seven strategies in bilateral cataract surgery: monofocal, monovision, diffractive bifocal, blended, refractive bifocal, trifocal, and extended depth of focus (EDOF) strategies. The effectiveness according to the objective spectacle independence rate (hereafter "rate", a novel indicator defined as the proportion of patients with binocular uncorrected distance, intermediate and near visual acuity all better than 0.1 logMAR, logarithm of the minimum angle of resolution), costs, average cost-effectiveness ratios (ACERs, $/1% rate), and incremental cost-effectiveness ratios (ICERs, $/1% incremental rate) were estimated.ResultsIn 194 participants (388 eyes), the trifocal strategy achieved the highest rate [93.10% (95% confidence interval (CI) 83.8-102.35%)]. The refractive bifocal strategy had the minimum ACER [$45.54/1% rate (95% CI 34.57-56.50)], followed by the blended [$59.10/1% rate (95% CI 31.72-86.48)], diffractive bifocal [$69.06/1% rate (95% CI 30.89-107.21)], EDOF [$72.85/1% rate (95% CI 52.02-93.70)], trifocal [$93.01/1% rate (95% CI 83.23-102.79)], monovision [$136.83/1% rate (95% CI - 55.40 to 329.14)], and monofocal [$264.45/1% rate (95% CI - 97.45 to 626.55)] strategies. Compared with the refractive bifocal strategy, the probabilities that the trifocal strategy (ICER $289.74/1% incremental rate) is very cost-effective and cost-effective were 81.7% and 93.2%, respectively, at the wiliness-to-pay threshold of one and three times China's annual disposable income per capita in 2021 per 10% incremental rates.ConclusionsCost-effectiveness analysis with ACER and ICER according to objective spectacle independence rate is a helpful tool to identify highly cost-effective presbyopia-correcting strategies in cataract surgery for clinical and policy decisions.Trial registrationClinicaltrials.gov (NCT04265846).
| S-EPMC9587195 | biostudies-literature
Project description:BackgroundRejuvenation of the under-eye area is a popular facial aesthetic treatment option.ObjectivesThis study evaluated the safety and effectiveness of VYC-15L for the correction of moderate or severe infraorbital hollowing.MethodsThis was a randomized, controlled, single-blind study with a primary endpoint defined as the proportion of participants with ≥1-grade improvement at Month 3 assessed by an evaluating investigator employing the Allergan Infraorbital Hollow Scale. Three-dimensional imaging was conducted to assess infraorbital volume up to Month 12. Procedure pain and injection-site responses (ISRs) were documented, and safety was monitored throughout the study.ResultsAt Month 3, the difference between treatment (83.1%) and control (15.6%) was 67.5% (95% CI = 52.9 to 82.0, P < 0.0001). 3D imaging showed a mean volume increase from baseline of 0.733 mL (left) and 0.777 mL (right) at Month 12. Mean pain scores were ≤1.7 (scale of 0 to 10). Most ISRs with initial treatment were mild/moderate and resolved in ≤1 week, including tenderness (49.5%), bruising (42.7%), and swelling (41.7%). Thirty-four participants had treatment-emergent adverse events (TEAEs), of which 14 (10.3%) had treatment-related TEAEs, including bruising (3.8%) and swelling/edema (2.9%), which resolved in ≤2 weeks. Three participants had swelling/edema starting >30 days posttreatment; 2 resolved in ≤4 days, 1 by 45 days. No treatment-related serious AEs were reported.ConclusionsVYC-15L was safe and effective for the correction of moderate or severe infraorbital hollowing and lasted through 1 year.Level of evidence: 2
| S-EPMC8520027 | biostudies-literature
Project description:BackgroundInfraorbital hollowing can be addressed with hyaluronic acid soft tissue fillers. A prospective, multicenter, evaluator-blinded, randomized, controlled study (NCT03418545) demonstrated the safety and effectiveness of Juvéderm Volbella XC (VYC-15L, Allergan Aesthetics, an AbbVie company, Irvine, CA) in adults seeking correction for infraorbital hollows.ObjectiveThe objective of the current analysis was to examine patient-reported outcomes from the clinical study.MethodsParticipants were randomly assigned 3:1 to the VYC-15L treatment group or the no-treatment control group. Outcome measurements included: evaluating investigator (EI)- and participant-assessed Global Aesthetic Improvement Scale (GAIS) scores, as well as participant responses to the FACE-Q Appraisal of Lower Eyelids, questions on treatment satisfaction, the extent to which patients were bothered by dark circles under their eyes, and willingness to recommend treatment to a friend.ResultsThe modified intent-to-treat population included 135 participants (median age, 47 years; 91.9% female). At Month 3, the majority of VYC-15L-treated participants showed improvements in the EI- and participant-assessed GAIS. The mean change from baseline to Month 3 score (32.7% increase) showed statistically significant improvement (mean [standard deviation], 17.8 [19.8], P < .0001). At Months 3 and 12 posttreatment, most VYC-15L-treated participants reported feeling satisfied with treatment and not feeling moderately or very bothered by dark circles under their eyes, and would recommend treatment to a friend.ConclusionsThe current analysis demonstrated the effectiveness of VYC-15L treatment to reduce infraorbital hollowing and to improve overall satisfaction based on validated patient-reported outcomes. Participant-assessed improvements aligned with EI-assessed outcomes and lasted for 1 year.Level of evidence: 2
| S-EPMC10575619 | biostudies-literature
Project description:Groin pain syndrome (GPS) is a prevalent issue in soccer. This study assessed the effectiveness of a new preventive protocol on GPS for youth soccer players. The protocol included targeted stretching and strengthening exercises for the adductor and core muscles from preseason to midseason. A questionnaire and two pain provocation tests were used for the evaluation. Mild GPS required positive results in at least two evaluations, while severe GPS was associated with pain incompatible with engagement in any activity confirmed by diagnostic ultrasound. Forty-two elite male athletes (aged 16.9 ± 0.7 years) participated in the study, with half of them assigned to the usual training (control group) and the remaining athletes undergoing the preventive protocol (treatment group) for 24 weeks. GPS rates were 14.3% (three diagnoses: two mild, one severe) in the treatment group and 28.6% (six diagnoses: three mild, three severe) in the control group. Toward the end of the season, three players, one from the treatment group and two from the control group had to stop playing due to severe GPS problems. In addition, one player in the control group stopped midseason. Even though the reduction in the risk of developing GPS was not significant (relative risk of 0.50 ([95%CI 0.14 to 1.74], p = 0.2759), the halved incidence of severe GPS and the increased muscle strength related to the treatment (p = 0.0277) are encouraging data for future studies.
| S-EPMC10486402 | biostudies-literature
Project description:BackgroundWhile some studies suggest that nutritional supplementation may reduce aggressive behavior in children, they have not examined whether its efficacy may be enhanced in conjunction with other treatment approaches. This study tests the hypothesis that a nutritional supplementation of omega-3, multivitamins, and minerals over 3 months, combined with cognitive behavior therapy, will reduce childhood aggression.MethodsIn this randomized, single-blind, stratified, factorial trial, a high-risk community sample of 290 children aged 11-12 years were randomized into Nutrition only, cognitive behavioral therapy (CBT) only, Nutrition + CBT, and Control groups. The primary outcome measures of child- and parent-reported aggressive and antisocial behavior were collected at 0 months (baseline), 3 months (end of treatment), 6 months (3 months posttreatment), and 12 months (9 months posttreatment). The trial ('Healthy Brains & Behavior: Understanding and Treating Youth Aggression (HBB)' was registered at ClinicalTrials.gov at https://clinicaltrials.gov/ct2/show/NCT00842439 RESULTS: For child self-reports, children in the Nutrition only group showed reduced externalizing behavior compared to Controls at 3 months. At 6 months, the Nutrition + CBT group scored lower on externalizing behavior compared to both CBT only and Control groups. Findings were more in evidence for an Aggressive-Reactive form of antisocial behavior than for a Callous-Proactive form. Effect sizes were in the small-to-medium range (d = -.33 to -.37). Group differences were not sustained 9 months posttreatment, and no other effects were significant.ConclusionsFindings provide some limited support for the efficacy of omega-3, vitamin, and mineral supplementation in reducing aggressive behavior in children, and represent the first evaluation of nutritional supplements in conjunction with CBT.
| S-EPMC10234432 | biostudies-literature
Project description:Prewarming has been shown to prevent intraoperative inadvertent hypothermia. Nevertheless, data about optimal prewarming-time from published clinical trials report contradictory results. We conducted this pilot study to evaluate routine clinical practice regarding prewarming and its effect on the prevalence of perioperative hypothermia in patients undergoing transurethral resection (TUR) under spinal anesthesia. This was a prospective, observational, pilot study to examine clinical practice in a tertiary hospital regarding prewarming in 140 consecutive patients. When prewarming (pw) was performed, forced-air warming was provided in the pre-anesthesia room for 15 (pw15), 30 (pw30), or 45 (pw45) min. Tympanic temperature was recorded upon entering the pre-anesthesia room, at the time of initiating surgery, and every 15 min intra-operatively. We also recorded duration of the surgical procedure and length of stay in the Post-Anesthesia Care Unit (PACU). Pw15 was performed in 34 patients, pw30 in 29 patients, and pw45 in 21 patients. Fifty-six patients did not receive pw and 96% of them developed hypothermia at the end of the surgical procedure, compared to 73% of patients in pw15 (p = 0.002), 75% in pw30 (p = 0.006) and 90% in pw45 (p = 0.3). Length of stay in the PACU was markedly shorter in pw15 (131 ± 69 min) and pw30 (123 ± 60 min) than in the non-pw group (197 ± 105 min) (p = 0.015 and p = 0.011, respectively). This difference was not significant in pw45 (129 ± 56 min) compared to non-pw patients. In conclusion, prewarming for 15 or 30 min before TUR under spinal anesthesia prevents development of hypothermia at the end of the surgical procedure.
| S-EPMC6848102 | biostudies-literature
Project description:BackgroundHypothermic protection against ischemic stroke has been reported by many studies. Hypothermia is supposed to mitigate the effects of deleterious genes and proteins and promote the activity of protective genes and proteins in the ischemic brain. Metallothionein (MT)-1/2 is thought to be a crucial factor for metal homeostasis, immune function, and apoptosis. This protein was found to exert protective effects in models of brain injury as well. In the present study, we investigated the effect of hypothermia on MT expression and the underlying mechanisms.MethodsCultured bEnd.3 brain endothelial cells were exposed to oxygen glucose deprivation and reperfusion (OGD+R). Reverse transcription PCR and western blot analyses were performed to measure the expression of MT, transcription factors, and methylation regulating factors. Transcription factor binding assays were also performed. Methylation profiles of the promoter area were obtained with pyrosequencing.ResultsHypothermia protected bEnd.3 cells from OGD+R. When the cells were exposed to OGD+R, MT expression was induced. Hypothermia augmented MT levels. While OGD+R-induced MT expression was mainly associated with metal regulatory transcription factor 1 (MTF-1), MT expression promoted by hypothermia was primarily mediated by the signal transducer and activator of transcription 3 (STAT3). Significantly increased STAT3 phosphorylation at Ser727 was observed with hypothermia, and JSI-124, a STAT-3 inhibitor, suppressed MT expression. The DNA demethylating drug 5-aza-2'-deoxycytidine (5-Aza) enhanced MT expression. Some of the CpG sites in the promoter MT=> it should be "the CpG sites in the MT promoter" showed different methylation profiles and some methylation regulating factors had different expressional profiles in the presence of OGD+R and hypothermia.ConclusionsWe demonstrated that hypothermia is a potent inducer of MT gene transcription in brain endothelial cells, and enhanced MT expression might contribute to protection against ischemia. MT gene expression is induced by hypothermia mainly through the STAT3 pathway. DNA methylation may contribute to MT gene regulation under ischemic or hypothermic conditions.
| S-EPMC3607999 | biostudies-literature
Project description:BackgroundDesflurane is not recommended during anesthesia induction because of its sympathetic stimulation effect, particularly in patients with myocardial ischemic disease. To date, the hemodynamic response to 1 MAC desflurane inhalation in combination with remifentanil infusion during anesthesia induction has rarely been reported.MethodsThis investigation was designed to compare hemodynamic responses to 1 MAC desflurane (group D, n = 200) with sevoflurane (group S, n = 200) during anesthesia induction and endotracheal intubation in adult patients undergoing elective spine surgery. Subgroup analysis of the different age subgroups was also performed. With continuous infusion of remifentanil 0.1 μg/kg/min, anesthesia was induced with propofol bolus, and endotracheal intubation was performed after muscle relaxation. Heart rate (HR) and mean arterial blood pressure (MAP) were measured every minute for 5 min after anesthesia induction (T1-5) and after endotracheal intubation (T6-10).ResultsHR was significantly higher in group D (n = 182) than in group S (n = 173) at T3-10 except at T6 (1 min after intubation) (all P < 0.05). In the age-based subgroup analyses, which subdivided the group D and S into four subgroups based on patient's age, the changes in HR from baseline values were significantly different between the coeval subgroups of patients in their 20-29 years and 30-39 years of age (all P < 0.05). MAP was reduced from baseline value, irrespective of group and age.ConclusionInhalation of 1 MAC desflurane during anesthesia induction with propofol bolus and remifentanil continuous infusion and during endotracheal intubation was more likely to induce elevations in HR more likely than 1 MAC sevoflurane, especially in younger patients.Trial registrationThis study was registered in the Clinical Research Information Service (CRIS, http://cris.nih.go.kr ) of the Republic of Korea on Feb 12, 2016 (Registration No. KCT 0,001,813).
| S-EPMC9945592 | biostudies-literature
Project description:Interventions: ESD with single balloon overtube
ESD without single balloon overtube
Primary outcome(s): treatment time
Study Design: Parallel Randomized
| 2647924 | ecrin-mdr-crc