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Effect of preheating on the maintenance of body temperature in surgical patients: a randomized clinical trial.

ABSTRACT: OBJECTIVE:to evaluate the effect of preheating on the maintenance of body temperature of patients submitted to elective gynecological surgeries. METHOD:eighty-six patients were randomized, without blinding, to receive usual care (heating with a cotton sheet and blanket) or preheating with a forced air system for 20 minutes (38°C). All patients were actively heated during the intraoperative period. Data were collected from admission of the patient in the surgical center until the end of the surgery. Body temperature was measured during the preoperative and intraoperative periods with an infrared tympanic thermometer. A thermo-hygrometer was used to monitor air temperature and humidity of the operating room. RESULTS:data indicated homogeneity between the groups investigated. There was no statistically significant difference between groups after preheating (p = 0.27). At the end of the surgery, the mean temperature of the groups studied was the same (36.8°C), with a statistically non-significant difference (p = 0.66). CONCLUSION:preheating with the heated forced air system had a similar effect to the usual care in the body temperature of patients submitted to elective gynecological surgeries. ClinicalTrials.gov n. NCT02422758. CAAE, n. 38320814.2.0000.5393.

SUBMITTER: Fuganti CCT

PROVIDER: S-EPMC6206825 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Effect of preheating on the maintenance of body temperature in surgical patients: a randomized clinical trial.

Fuganti Cibele Cristina Tramontini CCT Martinez Edson Zangiacomi EZ Galvão Cristina Maria CM

Revista latino-americana de enfermagem 20181025

<h4>Objective</h4>to evaluate the effect of preheating on the maintenance of body temperature of patients submitted to elective gynecological surgeries.<h4>Method</h4>eighty-six patients were randomized, without blinding, to receive usual care (heating with a cotton sheet and blanket) or preheating with a forced air system for 20 minutes (38°C). All patients were actively heated during the intraoperative period. Data were collected from admission of the patient in the surgical center until the e ...[more]

PMID: 30379244

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Project description:BackgroundOpioid dependence is an increasing public health problem all over the world. Patients with opioid dependence have to receive methadone maintenance therapy (MMT) as replacement therapy for years or even for their entire life. Acupuncture as a kind of therapy has been used to treat substance dependence for many years. Jin's three-needle acupuncture (JTN), a type of acupuncture technique, has been applied to treat various diseases for several decades. However, JTN as an acupuncture technique has not been used to treat patients receiving MMT. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of acupuncture as adjunctive therapy for patients receiving MMT.Methods/designThis study is a parallel-arm, randomized controlled trial that aims to evaluate the efficacy and safety of acupuncture as adjunctive therapy for patients receiving MMT. A total of 140 eligible participants who range in age from 18 to 60 years and fulfil the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V), for opiate dependence will be enrolled into this study. All eligible participants will be randomly assigned to the acupuncture group or routine group in a 1:1 allocation ratio. Participants who are enrolled in the acupuncture group will receive MMT and JTN treatment for 30 min per session. Meanwhile, those who are assigned to the routine arm will receive MMT only. All 18 sessions of JTN treatment will be delivered over 6 weeks (3 per week) and followed by a 4-week follow-up period. The primary outcome measure will be the visual analogue scale (VAS) for drug craving and the daily consumption of methadone (DCOM). Secondary outcome measures will include the urine test for opioid use, the 36-item Short Form Survey (SF-36), the Beck Anxiety Inventory (BAI), the Beck Depression Inventory II (BDI-II) and Pittsburgh sleep quality index (PSQI). VAS, DCOM, BAI, BDI-II and the urine test for opioid use will be evaluated at baseline, the second week, the fourth week, the sixth week and the tenth week. SF-36 and PSQI will be assessed at baseline, the fourth week, the sixth week and the tenth week.DiscussionThe results of this trial will provide evidence on the efficacy and safety of acupuncture as adjunctive therapy for patients receiving MMT.Trial registrationChinese Clinical Trial Registry ChiCTR1900026357 . Registered on 2 October 2019.

Project description:ImportanceGynecological laparoscopies are one of the most common surgical procedures worldwide. Limited evidence exists on rates of surgical site infections in patients undergoing gynecological laparoscopies and strategies to prevent these infections.ObjectiveTo compare rates of port-site infections, organ or space infections, and any type of surgical site infections among patients who underwent gynecological laparoscopies and received 1 of 3 types of skin preparation solutions.Design, setting, and participantsA double-blind randomized clinical trial was conducted between February 28, 2017, and November 26, 2018, at a tertiary university-affiliated referral center. A total of 661 patients 18 years or older who underwent an elective operative laparoscopy for treatment of nonmalignant gynecological disorders were randomly assigned in a 1:1:1 ratio to have their skin cleaned before surgery with alcohol-based chlorhexidine, alcohol-based povidone-iodine, or water-based povidone-iodine. Statistical analysis was performed from February 28, 2017, to November 26, 2018. Analyses were performed on a modified intention-to-treat basis.InterventionsA total of 221 patients were randomized to have their skin prepared preoperatively with water-based povidone-iodine, 220 were randomized to alcohol-based povidone-iodine, and 220 were randomized to alcohol-based chlorhexidine. The patients were blinded to the solution used to clean their skin. Patients were followed up 1 and 4 weeks after surgery by a physician who was blinded to the skin preparation solution used at surgery. Evidence of infection according to Centers for Disease Control and Prevention criteria were documented.Main outcomes and measuresThe primary outcome of this study was port-site infection 30 days after surgery. Secondary outcomes were organ or space infections and any type of surgical site infections; the study also aimed to prospectively describe rates of surgical site infections in gynecological laparoscopies.ResultsOf the 661 patients, 640 (96.8%; mean [SD] age, 36.2 [10.6] years) were examined after surgery by a physician at the study site and were included in the modified intention-to-treat analysis. The overall rate of port-site infection was 10.2% (65 of 640), rate of organ or space infection was 6.6% (42 of 640), and rate of any surgical site infection was 16.3% (104 of 640). The odds ratio for port-site infection for alcohol-based chlorhexidine vs water-based povidone-iodine was 1.13 (95% CI, 0.61-2.08), for alcohol-based chlorhexidine vs alcohol-based povidone-iodine was 1.34 (95% CI, 0.71-2.52), and for water-based povidone-iodine vs alcohol-based povidone-iodine was 1.19 (95% 0.62-2.27).Conclusions and relevanceSurgical site infections were more common than expected among patients who underwent gynecological laparoscopies. No skin preparation solution provided an advantage compared with the other solutions in reducing infection rates.Trial registrationhttp://anzctr.org.au Identifier: ACTRN12617000475347.

Project description:ImportanceTumor-treating fields (TTFields) is an antimitotic treatment modality that interferes with glioblastoma cell division and organelle assembly by delivering low-intensity alternating electric fields to the tumor.ObjectiveTo investigate whether TTFields improves progression-free and overall survival of patients with glioblastoma, a fatal disease that commonly recurs at the initial tumor site or in the central nervous system.Design, setting, and participantsIn this randomized, open-label trial, 695 patients with glioblastoma whose tumor was resected or biopsied and had completed concomitant radiochemotherapy (median time from diagnosis to randomization, 3.8 months) were enrolled at 83 centers (July 2009-2014) and followed up through December 2016. A preliminary report from this trial was published in 2015; this report describes the final analysis.InterventionsPatients were randomized 2:1 to TTFields plus maintenance temozolomide chemotherapy (n = 466) or temozolomide alone (n = 229). The TTFields, consisting of low-intensity, 200 kHz frequency, alternating electric fields, was delivered (≥ 18 hours/d) via 4 transducer arrays on the shaved scalp and connected to a portable device. Temozolomide was administered to both groups (150-200 mg/m2) for 5 days per 28-day cycle (6-12 cycles).Main outcomes and measuresProgression-free survival (tested at α = .046). The secondary end point was overall survival (tested hierarchically at α = .048). Analyses were performed for the intent-to-treat population. Adverse events were compared by group.ResultsOf the 695 randomized patients (median age, 56 years; IQR, 48-63; 473 men [68%]), 637 (92%) completed the trial. Median progression-free survival from randomization was 6.7 months in the TTFields-temozolomide group and 4.0 months in the temozolomide-alone group (HR, 0.63; 95% CI, 0.52-0.76; P < .001). Median overall survival was 20.9 months in the TTFields-temozolomide group vs 16.0 months in the temozolomide-alone group (HR, 0.63; 95% CI, 0.53-0.76; P < .001). Systemic adverse event frequency was 48% in the TTFields-temozolomide group and 44% in the temozolomide-alone group. Mild to moderate skin toxicity underneath the transducer arrays occurred in 52% of patients who received TTFields-temozolomide vs no patients who received temozolomide alone.Conclusions and relevanceIn the final analysis of this randomized clinical trial of patients with glioblastoma who had received standard radiochemotherapy, the addition of TTFields to maintenance temozolomide chemotherapy vs maintenance temozolomide alone, resulted in statistically significant improvement in progression-free survival and overall survival. These results are consistent with the previous interim analysis.Trial registrationclinicaltrials.gov Identifier: NCT00916409.

Project description:ImportancePatients with chronic kidney disease have impaired vitamin D activation and elevated cardiovascular risk. Observational studies in patients treated with hemodialysis showed that the use of active vitamin D sterols was associated with lower risk of all-cause mortality, regardless of parathyroid hormone levels.ObjectiveTo determine whether vitamin D receptor activators reduce cardiovascular events and mortality in patients without secondary hyperparathyroidism undergoing hemodialysis.Design, setting, and participantsRandomized, open-label, blinded end point multicenter study of 1289 patients in 207 dialysis centers in Japan. The study included 976 patients receiving maintenance hemodialysis with serum intact parathyroid hormone levels less than or equal to 180 pg/mL. The first and last participants were enrolled on August 18, 2008, and January 26, 2011, respectively. The final date of follow-up was April 4, 2015.InterventionsTreatment with 0.5 μg of oral alfacalcidol per day (intervention group; n = 495) vs treatment without vitamin D receptor activators (control group; n = 481).Main outcomes and measuresThe primary outcome was a composite measure of fatal and nonfatal cardiovascular events, including myocardial infarctions, hospitalizations for congestive heart failure, stroke, aortic dissection/rupture, amputation of lower limb due to ischemia, and cardiac sudden death; coronary revascularization; and leg artery revascularization during 48 months of follow-up. The secondary outcome was all-cause death.ResultsAmong 976 patients who were randomized from 108 dialysis centers, 964 patients were included in the intention-to-treat analysis (median age, 65 years; 386 women [40.0%]), and 944 (97.9%) completed the trial. During follow-up (median, 4.0 years), the primary composite outcome of cardiovascular events occurred in 103 of 488 patients (21.1%) in the intervention group and 85 of 476 patients (17.9%) in the control group (absolute difference, 3.25% [95% CI, -1.75% to 8.24%]; hazard ratio, 1.25 [95% CI, 0.94-1.67]; P = .13). There was no significant difference in the secondary outcome of all-cause mortality between the groups (18.2% vs 16.8%, respectively; hazard ratio, 1.12 [95% CI, 0.83-1.52]; P = .46). Of the 488 participants in the intervention group, 199 (40.8%) experienced serious adverse events that were classified as cardiovascular, 64 (13.1%) experienced adverse events classified as infection, and 22 (4.5%) experienced malignancy-related serious adverse events. Of 476 participants in the control group, 191 (40.1%) experienced cardiovascular-related serious adverse events, 63 (13.2%) experienced infection-related serious adverse events, and 21 (4.4%) experienced malignancy-related adverse events.Conclusions and relevanceAmong patients without secondary hyperparathyroidism undergoing maintenance hemodialysis, oral alfacalcidol compared with usual care did not reduce the risk of a composite measure of select cardiovascular events. These findings do not support the use of vitamin D receptor activators for patients such as these.Trial registrationUMIN-CTR Identifier: UMIN000001194.

Project description:ImportanceDuring the COVID-19 pandemic, wearing masks has become necessary, especially within health care. However, to our knowledge, the consequences of mask wearing on communication between surgeons and patients have not been studied.ObjectiveTo evaluate the effects of clear vs standard covered masks on communication during surgical clinic encounters.DesignThis randomized clinical trial examined communication between surgeons and their patients when surgeons wore clear vs covered masks in surgical outpatient clinics at a single academic medical center. New patients were recruited from participating surgeons' clinic schedules.InterventionsSurgeons wore either clear masks or covered masks for each clinic visit with a new patient, based on a per-visit randomization plan.Main outcomes and measuresThe primary outcome measures included patient perceptions of (1) surgeon communication and (2) trust in surgeons, as well as (3) quantitative assessments and (4) qualitative assessments regarding patient impressions of the surgeon's mask. After the clinic encounter, patients completed a verbal survey including validated Clinician and Group Consumer Assessment of Healthcare Providers and Systems questions. Additional questions involved surgeon empathy, trust, and the patient's impression of the surgeon's mask. Data were analyzed by comparing patient data in the clear vs covered groups using Cochran-Mantel-Haenszel tests, and comments were analyzed for themes.ResultsTwo hundred patients were enrolled from 15 surgeons' clinics spanning 7 subspecialties. When surgeons wore a clear mask, patients rated their surgeons higher for providing understandable explanations (clear, 95 of 100 [95%] vs covered, 78 of 100 [78%]; P < .001), demonstrating empathy (clear, 99 [99%] vs covered, 85 [85%]; P < .001), and building trust (clear, 94 [94%] vs covered, 72 [72%]; P < .001). Patients preferred clear masks (clear, 100 [100%] vs covered, 72 [72%]; P < .001), citing improved surgeon communication and appreciation for visualization of the face. Conversely, 8 of 15 surgeons (53%) were unlikely to choose the clear mask over their standard covered mask.Conclusions and relevanceThis randomized clinical trial demonstrates that patients prefer to see their surgeon's face. Surgeons who wore clear masks were perceived by patients to be better communicators, have more empathy, and elicit greater trust. Because masks will remain part of the health care landscape for some time, deliberate attention to preserving communication within the surgeon-patient relationship is warranted.Trial registrationClinicalTrials.gov Identifier: NCT04595695.

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Effect of preheating on the maintenance of body temperature in surgical patients: a randomized clinical trial.

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Effect of preheating on the maintenance of body temperature in surgical patients: a randomized clinical trial.

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