scholarly journals Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar decompression surgery in the Prone Position: A Randomized Controlled Clinical Trial

2019 ◽  
Author(s):  
DI XIA ◽  
Xu Li ◽  
Li Xu ◽  
Yuguang Huang
Keyword(s):  
Elderly Patients ◽  
Prone Position ◽  
Fluid Therapy ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Decompression Surgery ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Goal Directed Fluid Therapy ◽  
Lumbar Decompression Surgery

Abstract Background Major lumber spine surgeries in the prone position have high mortality and morbidity, especially in elderly patients. Intraoperative goal-directed fluid therapy (GDT) has improved outcomes in abdominal and thoracic surgical procedures. However the utility of intraoperative GDT in spine surgery has not been present. In this study, we investigated whether GDT would reduce the postoperative complications in elderly patients undergoing lumbar stenosis decompression in the prone position. Methods In this single-center, randomized controlled clinical trial, we randomly assigned 84 patients aged > 60 undergoing lumbar decompression surgery to either a GDT group or a control group, who received conventional anesthesiologist-directed fluid therapy. Perioperative lactic acid concentrations with 7 different time point, intraoperative fluid balance and postoperative complications from admittance to 30 days after surgery were recorded. Results Lactic acid concentrations were higher in the control group than in the GTD group from the start of operation to 24 h after the operation, reaching maximum concentrations at exit from the post-anesthesia care unit (2.50 ± 1.22 mmol/l compared with 1.32 ± 0.42 mmol/l in controls; p<0.001). More total fluid volume was infused in GDT patients than in control patients (2416 ± 539 ml vs. 2036 ± 424ml, p<0.001). GDT patients had fewer infectious complications that did control patients (4.7% vs. 19.5%, P<0.001) after the surgery. Conclusion GDT during lumbar decompressive surgery under general anesthesia in elderly patients results in significantly better postoperative outcomes, which may be due to optimal fluid management and better perfusion of tissues and organs. Trial registration NCT02470221. Initial registration date was 06/09/2015.

scholarly journals A randomized controlled clinical trial of the effect of supportive counseling on mental health in Iranian mothers of premature infants

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Leila Seiiedi-Biarag ◽  
Mojgan Mirghafourvand ◽  
Khalil Esmaeilpour ◽  
Shirin Hasanpour
Keyword(s):  
Mental Health ◽  
Clinical Trial ◽  
Premature Infants ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Postpartum Bonding ◽  
Supportive Counseling

Abstract Background Premature birth can affect maternal mental health. Considering that the mental health disorder in mothers may play a vital role in the growth and development of their children, therefore, this study was conducted to determine the effect of supportive counseling on mental health (primary outcome), mother-child bonding and infant anthropometric indices (secondary outcomes) in mothers of premature infants. Methods This randomized controlled clinical trial was carried out on 66 mothers with hospitalized neonates in the NICU of Alzahra hospital in Tabriz- Iran. Participants were randomly allocated into two groups of intervention (n = 34) and control (n = 32) through a block randomization method. The intervention group received 6 sessions of supportive counseling (45–60 minutes each session) by the researcher, and the control group received routine care. Questionnaires of Goldberg General Health and the postpartum bonding were completed before the intervention (first 72 hours postpartum) and 8 weeks postpartum. Also, the anthropometric index of newborns were measured at the same time. Results There was no statistically significant difference between the two groups in terms of socio-demographic characteristics. After the intervention, based on ANCOVA with adjusting the baseline score, mean score of mental health (AMD: -9.8; 95% Confident Interval (95% CI): -12.5 to -7.1; P < 0.001) and postpartum bonding (AMD: -10.0; 95% CI: -0.6 to 13.9; P < 0.001) in the counseling group was significantly lower than those of the control group; however, in terms of weight (P = 0.536), height (P = 0.429) and head circumference (P = 0.129), there was no significant difference between the two groups. Conclusions Supportive counseling may improve mental health and postpartum bonding in mothers of premature infants. Thus, it may be recommendable for health care providers to offer it to mothers. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N45. Date of registration: October 29, 2018.

scholarly journals Supragingival plaque removal with and without dentifrice: a randomized controlled clinical trial

2012 ◽  
Vol 23 (3) ◽  
pp. 235-240 ◽  
Author(s):  
Fabricio B. Zanatta ◽  
Raquel P. Antoniazzi ◽  
Tatiana M. P. Pinto ◽  
Cassiano K. Rösing
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Separate Analysis ◽  
Randomized Controlled Clinical Trial ◽  
Significance Level ◽  
Plaque Removal ◽  
Randomized Controlled ◽  
Removal Capacity

The aim of this study was to compare the efficacy of dental plaque removal by brushing with and without conventional dentifrice. Twenty-four students aged 17 to 28 years participated in this randomized controlled clinical trial. Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 h of cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by Student's paired sample t-test at 5% significance level. The results showed that both groups after toothbrushing presented statistically significant reductions in plaque, with no differences between them (from 3.06 ± 0.54 to 1.27 ± 0.26 versus from 3.07 ± 0.52 to 1.31 ± 0.23). A separate analysis of the buccal and lingual aspects also showed no significant differences between groups. It may be concluded that the use of a conventional dentifrice during toothbrushing does not seem to enhance plaque removal capacity.

scholarly journals A randomized clinical trial to stimulate the cholinergic anti-inflammatory pathway in patients with moderate COVID-19-pneumonia using a slow-paced breathing technique

2021 ◽  
Author(s):  
Elisabeth Maria Balint ◽  
Beate Grüner ◽  
Sophia Haase ◽  
Mandakini Kaw-Geppert ◽  
Julian Thayer ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Interleukin 6 ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Single Center ◽  
Paced Breathing ◽  
Randomized Controlled ◽  
Lr Test ◽  
Practice Time

AbstractImportanceVagus nerve stimulation via slow-paced breathing could serve as adjuvant therapeutic approach to reduce excessive inflammation in coronavirus disease 2019 (COVID-19) pneumonia.ObjectiveDoes a slow-paced breathing technique increasing vagal activity reduce Interleukin-6 (IL-6) in patients hospitalized with moderate COVID-19 pneumonia compared to standard care?DesignSingle-center randomized controlled clinical trial with enrolment from February 23rd 2021 through June 17th 2021 and follow-up until July 22nd 2021.SettingWard for infectious diseases and temporary COVID-19 ward, Ulm University Hospital, GermanyParticipantsConsecutive sample of patients hospitalized with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (primary diagnosis). Of 131 patients screened, 48 patients were randomized and 46 patients analyzed (N=23 per group).InterventionsSlow-paced 20-minute breathing exercise three times a day with six breaths per minute (inhale-to-exhale ratio 4:6).Main outcomes and measuresDifferences between intervention and control group in IL-6 calculated using multilevel mixed-effect linear regression models with random slope including the covariates relevant comorbidities, COVID-19 medication, and age.ResultsMean age 57 years±13 years, N= 28 (60%) male, N=30 (65%) with relevant comorbidities. The model including group by time interaction revealed a significantly lower trajectory of IL-6 in the intervention group compared to the control group (effect size Cohens f2=0.11, LR-test p=.040) in the intention-to-treat sample, confirmed by treatment-per-protocol analysis (f2=0.15, LR-test p=.022).Exploratory analysis using the median split of practice time to predict IL-6 of the next morning indicated a dose-response relationship with beneficial effects of practice time above 45 minutes a day.Three patients in each group were admitted at ICU, one died. Oxygen saturation increased during slow-paced breathing (from 95.1%±2.1% to 95.4%±1.6%, p=0.006).Conclusion and relevancePatients practicing slow-paced breathing had significantly lower IL-6 values than controls without relevant side effects. Further trials should evaluate clinical outcomes as well as an earlier start of the intervention, i.e., at symptom onset. This would offer an access to a therapy option not only for high-income, but also for low- and middle-income countries.Trial registrationGerman register of clinical trials (ID: DRKS00023971) https://www.drks.de, Universal Trial Number (UTN) U1111-1263-8658;Key pointsQuestionCan slow-paced breathing reduce Interleukin-6 (IL-6) in hospitalized patients with moderate coronavirus disease 2019 (COVID-19) pneumonia?FindingsSingle-center randomized controlled clinical trial including 46 patients hospitalized with moderate COVID-19 pneumonia. Compared to controls, IL-6 values were significantly lower (small-to-medium effect sizes) in patients who were instructed to practice six breaths per minute for 20 minutes three times a day. More minutes of slow-paced breathing were significantly correlated with lower IL-6 values the next morning.MeaningSlow-paced breathing could be a safe and feasible adjuvant therapeutic approach in moderate COVID-19 pneumonia.

scholarly journals Effect of Physical Therapy on Bone Remodelling in Preterm Infants. A Multicenter Randomized Controlled Clinical Trial

2022 ◽  
Author(s):  
Galaad Torró-Ferrero ◽  
Francisco Javier Fernández-Rego ◽  
Rosario Jiménez-Liria ◽  
Juan Jose Agüera-Arenas ◽  
Jessica Piñero-Peñalver ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Bone Formation ◽  
Preterm Infants ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Bone Modeling ◽  
Randomized Controlled Clinical Trial ◽  
Bone Biomarkers ◽  
Randomized Controlled

Abstract Background: Preterm infants have a low level of bone mineralization compared to those born at term, since 80% of calcium incorporation occurs at the end of pregnancy. The purpose of the present study was to investigate the effect of reflex locomotion therapy on bone modeling and growth in preterm infants and to compare its effect with those of other Physiotherapy modalities.Methods: A multicentre randomized controlled clinical trial was conducted (02/2016 – 07/2020). 106 preterm infants born at the Virgen de la Arrixaca University Clinical Hospital, the General University Hospital of Elche and the Torrecárdenas Hospital in Almería, between 29 and 34 weeks with hemodynamic stability, complete enteral nutrition and without any metabolic, congenital, genetic, neurological or respiratory disorders were evaluated for inclusion. Infants were randomly assigned to three groups: one group received reflex locomotion therapy (EGrlt); another group received passive mobilizations with gentle joint compression (EGpmc); and the control group received massage (CG). All treatments were carried out in the neonatal units lasting one month. The main outcome measure was bone formation and resorption measured with bone biomarkers. A mixed ANOVA was used to compare the results of bone biomarkers, and anthropometric measurements. Results: Infants were randomized to EGrlt (n = 38), EGpmc (n = 32), and CG (n = 36). All groups were similar in terms of gender (p = 0.891 female 47.2%), gestational age (M = 30.753, SD = 1.878, p = 0.39) and birth weight (M = 1413.45, SD = 347.36, p = 0.157). At the end of the study, significant differences were found between the groups in their interaction in bone formation, measured with osteocalcin [F (2,35) = 4.92, p = 0.013, ηp2 = 0.043], in benefit of the EGrlt. Conclusions: Reflex locomotion therapy has been effective in improving bone formation, more so than other Physiotherapy modalities. Therefore, reflex locomotion therapy could be considered one of the most effective physiotherapeutic modalities for the prevention and treatment of osteopenia of prematurity Trial registrstion: Trial retrospectively registered at ClinicalTrials.gov. First posted on 22/04/2020. Registration number: NCT04356807. URL: https://clinicaltrials.gov/ct2/show/NCT04356807?cond=Physical+Therapy+to+Prevent+Osteopenia+in+Preterm+Infants&draw=2&rank=1

scholarly journals The effect of prenatal counseling on breastfeeding self-efficacy and frequency of breastfeeding problems in mothers with previous unsuccessful breastfeeding: A randomized controlled clinical trial

2020 ◽  
Author(s):  
fahimeh sehhatie shafaei ◽  
mojgan mirghafourvand ◽  
shiva havizari
Keyword(s):  
Self Efficacy ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Prenatal Counseling ◽  
Control Groups ◽  
Randomized Controlled ◽  
Breastfeeding Problems ◽  
And Control

Abstract Background: Breastfeeding is one of the most important interfering factors in infants’ health. Monitoring mothers’ performance and providing them with the feedback helps to increase their self-efficacy, interest in learning, and level of performance. The present research evaluates the effect of prenatal counseling on the breastfeeding self-efficacy and frequency of breastfeeding problems in mothers with previous unsuccessful breastfeeding.Methods: This randomized controlled clinical trial was conducted on 108 pregnant women with unsuccessful breastfeeding in Tabriz health centers during 2017-2018. The participants were randomly assigned to intervention and control groups. The intervention group had four prenatal counseling sessions and the controls only received routine care. Then, the mothers who gave birth to their children received a counseling session up to 4 months after the delivery. The Breastfeeding Self-Efficacy (BSES) questionnaire and the frequency of breast feeding problems checklist on the 15th day, and 2nd and 4th month were completed both by the intervention and control groups.Results: The mean (SD) of breastfeeding self-efficacy was 119.3 (10.5), 128.3 (8.3) and 133.8 (10.3) in the intervention group and 105.3 (16.1), 105.7 (19.7) and 109.4 (24.7) in the control group on the 15th day, 2nd and 4th month after the delivery, respectively. There was a significant difference in terms of breastfeeding self-efficacy between intervention and control group on the 15th day (p<0.001), and 2nd (p<0.001) and 4th (p<0.001) month after the delivery. The frequency of breastfeeding problems on the 15th (p=0.008), 2nd (p<0.001) and 4th (p<0.001) after the delivery was significantly different in most cases of the intervention group when compared to the controls.Conclusion: The results indicated that prenatal counseling can increase mothers’ breastfeeding self-efficacy and solves most breastfeeding problems during postpartum period.Trial registration: IRCT20100109003027N19

scholarly journals Randomized Controlled Clinical Trial of Nanostructured Carbonated Hydroxyapatite for Alveolar Bone Repair

Materials ◽  
2019 ◽  
Vol 12 (22) ◽  
pp. 3645 ◽  
Author(s):  
Rodrigo F. B. Resende ◽  
Suelen C. Sartoretto ◽  
Marcelo J. Uzeda ◽  
Adriana T. N. N. Alves ◽  
José A. Calasans-Maia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bone Repair ◽  
Alveolar Bone ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Double Blind ◽  
Socket Preservation ◽  
Carbonated Hydroxyapatite ◽  
Randomized Controlled

The properties of the biodegradation of bone substitutes in the dental socket after extraction is one of the goals of regenerative medicine. This double-blind, randomized, controlled clinical trial aimed to compare the effects of a new bioabsorbable nanostructured carbonated hydroxyapatite (CHA) with a commercially available bovine xenograft (Bio-Oss®) and clot (control group) in alveolar preservation. Thirty participants who required tooth extraction and implant placement were enrolled in this study. After 90 days, a sample of the grafted area was obtained for histological and histomorphometric evaluation and an implant was installed at the site. All surgical procedures were successfully carried out without complications and none of the patients were excluded. The samples revealed a statistically significant increase of new bone formation (NFB) in the CHA group compared with Bio-Oss® after 90 days from surgery (p < 0.05). However, the clot group presented no differences of NFB compared to CHA and Bio-Oss®. The CHA group presented less amount of reminiscent biomaterial compared to Bio-Oss®. Both biomaterials were considered osteoconductors, easy to handle, biocompatible, and suitable for alveolar filling. Nanostructured carbonated hydroxyapatite spheres promoted a higher biodegradation rate and is a promising biomaterial for alveolar socket preservation before implant treatment.

scholarly journals Preoperative carbohydrate loading and intraoperative goal-directed fluid therapy for elderly patients undergoing open gastrointestinal surgery: a prospective randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Xia Liu ◽  
Peng Zhang ◽  
Meng Xue Liu ◽  
Jun Li Ma ◽  
Xin Chuan Wei ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Elderly Patients ◽  
Fluid Therapy ◽  
Controlled Trial ◽  
Gastrointestinal Surgery ◽  
Randomized Controlled ◽  
Carbohydrate Loading ◽  
Prospective Randomized Controlled Trial ◽  
Preoperative Carbohydrate Loading ◽  
Goal Directed Fluid Therapy

Abstract Background The effect of a combination of a goal-directed fluid protocol and preoperative carbohydrate loading on postoperative complications in elderly patients still remains unknown. Therefore, we designed this trial to evaluate the relative impact of preoperative carbohydrate loading and intraoperative goal-directed fluid therapy versus conventional fluid therapy (CFT) on clinical outcomes in elderly patients following gastrointestinal surgery. Methods This prospective randomized controlled trial with 120 patients over 65 years undergoing gastrointestinal surgery were randomized into a CFT group (n = 60) with traditional methods of fasting and water-deprivation, and a GDFT group (n = 60) with carbohydrate (200 ml) loading 2 h before surgery. The CFT group underwent routine monitoring during surgery, however, the GDFT group was conducted by a Vigileo/FloTrac monitor with cardiac index (CI), stroke volume variation (SVV), and mean arterial pressure (MAP). For all patients, demographic data, intraoperative parameters and postoperative outcomes were recorded. Results Patients in the GDFT group received significantly less crystalloids fluid (1111 ± 442.9 ml vs 1411 ± 412.6 ml; p < 0.001) and produced significantly less urine output (200 ml [150–300] vs 400 ml [290–500]; p < 0.001) as compared to the CFT group. Moreover, GDFT was associated with a shorter average time to first flatus (56 ± 14.1 h vs 64 ± 22.3 h; p = 0.002) and oral intake (72 ± 16.9 h vs 85 ± 26.8 h; p = 0.011), as well as a reduction in the rate of postoperative complications (15 (25.0%) vs 29 (48.3%) patients; p = 0.013). However, postoperative hospitalization or hospitalization expenses were similar between groups (p > 0.05). Conclusions Focused on elderly patients undergoing open gastrointestinal surgery, we found perioperative fluid optimisation may be associated with improvement of bowel function and a lower incidence of postoperative complications. Trial registration ChiCTR, ChiCTR1800018227. Registered 6 September 2018 - Retrospectively registered.

scholarly journals Development of Cognitive Abilities through the Abacus in Primary Education Students: A Randomized Controlled Clinical Trial

2021 ◽  
Vol 11 (2) ◽  
pp. 83
Author(s):  
Samuel P. León ◽  
María del Carmen Carcelén Fraile ◽  
Inmaculada García-Martínez
Keyword(s):  
Clinical Trial ◽  
Cognitive Abilities ◽  
Auditory Memory ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
School Students ◽  
Beneficial Effects ◽  
Randomized Controlled ◽  
The Difference

(1) Background: An abacus is an instrument used to perform different arithmetic operations. The objective was to analyze the benefits of mathematical calculations made with an abacus to improve the concentration, attention, memory, perceptive attitudes, and creativity cognitive abilities of primary school students. (2) Methods: A total of 65 children, aged 7–11 years (8.49 ± 1.65) participated in this randomized controlled clinical trial. The children were randomly distributed into a control group (n = 34) and experimental group (n = 31). The questionnaires used were the D2 test to measure attention and concentration, the Difference Perception Test (FACE-R) test for the perception of differences, the test of immediate auditory memory (AIM), and the test to evaluate creative intelligence (CREA). (3) Results: No significant differences were found between both groups before the intervention. Significant improvements were observed in the cognitive parameters of concentration, memory, perceptive attitudes, and creativity after the intervention, using the abacus, with respect to the control group. (4) Conclusions: It is demonstrated that a calculation program based on the use of the abacus for 8 weeks has beneficial effects on the cognitive capacities of concentration, immediate auditory memory, perceptive attitudes, and creativity. In addition, the benefits of using the abacus to improve cognitive attitudes are reported.

scholarly journals Adhesion prevention after endometriosis surgery — results of a randomized, controlled clinical trial with second-look laparoscopy

2021 ◽  
Author(s):  
Bernhard Krämer ◽  
Jürgen Andress ◽  
Felix Neis ◽  
Sascha Hoffmann ◽  
Sara Brucker ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Saline Solution ◽  
Adhesion Formation ◽  
Adhesion Prevention ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Adhesion Barrier ◽  
Randomized Controlled ◽  
Endometriosis Surgery

Abstract Purpose Adhesion formation after endometriosis surgery is a severe problem affecting up to 90% of patients. Possible complications include chronic pain, ileus, and secondary infertility. Therefore, effective adhesion prophylaxis is desirable, for which the adhesion barrier 4DryField® PH is evaluated in the present clinical study. It is a starch-based powder that forms a gel after irrigation with saline solution and thus separates surgical sites as physical barrier for adhesion prevention. Methods Fifty patients with extensive and deep infiltrating endometriosis were included in this prospective, randomized, controlled clinical trial with two-staged laparoscopic approach. The patients were randomized into two groups, one receiving 4DryField® PH and the other irrigation with saline solution for adhesion prevention. Adhesion formation was directly scored during second-look interventions considering incidence, extent, and severity. Adhesion prevention treatment in the second surgery was performed corresponding to the first intervention to evaluate the long-term outcome in the later course. Results Both groups were comparable with respect to relevant patient parameters. Severity and extent of adhesions were significantly reduced by 85% in the 4DryField® PH group compared to the control group (mean total adhesion score 2.2 vs. 14.2; p = 0.004). Incidence of adhesion formation based on the number of affected sites was significantly reduced by 53% in the intervention vs. control group (mean 1.1 vs. 2.3 sites; p = 0.004). Follow-up of secondary endpoints is not yet completed; results will become available at a later stage. Conclusion Adhesion formation could be reduced significantly by 85% by application of the adhesion barrier 4DryField® PH. Trial registration Trial registration main ID: DRKS00014720, secondary ID: U1111-1213-4142; date of registration 09th May 2018.

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