scholarly journals Pupillometry pain index decreases intraoperative sufentanyl administration in cardiac surgery: a prospective randomized study

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Vivien Berthoud ◽  
Maxime Nguyen ◽  
Anouck Appriou ◽  
Omar Ellouze ◽  
Mohamed Radhouani ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cardiac Surgery ◽  
Primary Outcome ◽  
Randomized Study ◽  
Intervention Group ◽  
Prospective Randomized Study ◽  
Control Group ◽  
Standard Group ◽  
Postoperative Course ◽  
The Impact

AbstractPupillometry has proven effective for the monitoring of intraoperative analgesia in non-cardiac surgery. We performed a prospective randomized study to evaluate the impact of an analgesia-guided pupillometry algorithm on the consumption of sufentanyl during cardiac surgery. Fifty patients were included prior to surgery. General anesthesia was standardized with propofol and target-controlled infusions of sufentanyl. The standard group consisted of sufentanyl target infusion left to the discretion of the anesthesiologist. The intervention group consisted of sufentanyl target infusion based on the pupillary pain index. The primary outcome was the total intraoperative sufentanyl dose. The total dose of sufentanyl was lower in the intervention group than in the control group and (55.8 µg [39.7–95.2] vs 83.9 µg [64.1–107.0], p = 0.04). During the postoperative course, the cumulative doses of morphine (mg) were not significantly different between groups (23 mg [15–53] vs 24 mg [17–46]; p = 0.95). We found no significant differences in chronic pain at 3 months between the 2 groups (0 (0%) vs 2 (9.5%) p = 0.49). Overall, the algorithm based on the pupillometry pain index decreased the dose of sufentanyl infused during cardiac surgery.Clinical trial number: NCT03864016.

A Randomized Study to Assess the Impact of Pharmacist Counseling of Employer-Based Health Plan Beneficiaries With Diabetes

2011 ◽  
Vol 25 (2) ◽  
pp. 169-179 ◽  
Author(s):  
Dale F. Kraemer ◽  
Wayne A. Kradjan ◽  
Theresa M. Bianco ◽  
Judi A. Low
Keyword(s):  
Diabetes Management ◽  
Statistical Significance ◽  
Glycosylated Hemoglobin ◽  
Randomized Study ◽  
Intervention Group ◽  
Control Group ◽  
Counseling Intervention ◽  
Care Plans ◽  
Pharmacist Counseling ◽  
The Impact

Objective: To assess the impact of pharmacist counseling on empowering people with diabetes to better self-care. Introduction: Community-based pharmacists can play a key role in educating and empowering people in such programs. Methods: A randomized trial compared the effects of pharmacist counseling (intervention group) with printed materials (control group) in diabetic beneficiaries of several employer-based health care plans. All participants also received waiver of out-of-pocket expenses for diabetic-related medications and supplies. Clinical, humanistic, and claim outcomes were evaluated at baseline and at 1 year follow-up. Results: Sixty-seven beneficiaries participated in this study. The 0.50% decrease from baseline in glycosylated hemoglobin (A1c) was statistically significant ( P = .0008) in the intervention group and the difference between the groups approached statistical significance ( P = .076). Beneficiaries in both groups had greater claim costs for diabetic-related medications and supplies during the study year. Both groups also improved in ability to manage their diabetes with the counseling group showing a significantly better understanding of diabetes ( P = .0024). Conclusion: There was a trend toward improvement in A1c in patients counseled by pharmacist with an increased utilization of diabetes-related medications and supplies. Counseling also improved diabetes knowledge and empowered patients to better diabetes management.

Effects of a Risk-Stratified Treatment in Patients with Chronic Back Pain in Rehabilitation: Results of a Controlled Clinical Trial

2020 ◽  
Author(s):  
Christian Schmidt ◽  
Sebastian Bernert ◽  
Matthias Sing ◽  
Sandra Fahrenkrog ◽  
Dominika Urbanski-Rini ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Back Pain ◽  
Functional Capacity ◽  
Primary Outcome ◽  
Intervention Group ◽  
Analysis Of Covariance ◽  
Individual Risk ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Risk Profiles

Abstract Background and Aim The management of chronic low back pain is a persisting challenge for multidisciplinary biopsychosocial rehabilitation (MBR). A promising approach to improve the effectiveness is better individual tailoring of the therapeutic minutes to the impairment. We designed a questionnaire-based algorithm to identify individual risk profiles, which allows physicians and patients to decide upon the kind and amount of suitable and adequate therapeutic components of MBR. Our aim was to test whether the algorithm leads to a shift in the therapeutic components depending on the impairment, which should significantly increase the functional capacity of the rehabilitants 6 months after the end of rehabilitation. Methods Between January and November 2016, a controlled clinical trial with a sequential arrangement of study groups and 3 measurement time points (start of rehabilitation, end of rehabilitation and 6-month follow-up) was conducted. The control group (CG) passed through the standard inpatient MBR. In the intervention group (IG)the MBR components were matched to the individual risk-profiles determined via a new algorithm. The shift of therapeutic minutes is displayed via boxplots. The primary outcome was statistically tested by applying an analysis of covariance. All secondary outcomes are presented descriptively. Results Of 169 patients in total, 85 were assigned to the CG and 84 to the IG. Complete data concerning the primary outcome were available for 76 (89.4%) patients in the CG and 75 (89.3%) patients in the IG. Compared to the CG, the boxplots for the IG show a better fit of therapeutic minutes according to the impairments. For example, in the IG, the mean value of psychological therapies was about 120 min if they were impaired and 44.3 min if not. In contrast, impaired tested patients of the CG shown mean values of those therapies of about 96.6 min and 50.6 min if not. The baseline adjusted mean difference in functional capacity was significantly (p=0.047) improved by 4.4 points (95% CI: 0.063–8.465) in favor of the IG. . Main limitation is lack of randomization. In order to avoid inadequate therapy recommendations, the physician had the decision-making authority over the therapies. Conclusion The application of the developed algorithm for individual adaptation of the MBR increases the effectiveness of rehabilitation in terms of functional capacity.

scholarly journals Clinical Outcomes and Cost of Ventilator Weaning and Endotracheal Extubation Guided by An Established Ventilator Weaning Protocol in Patients Undergoing Elective Cardiac Surgery

2021 ◽  
Vol 73 (12) ◽  
pp. 815-822
Author(s):  
Supanan Innok ◽  
Witchuda Dokphueng ◽  
Kamol Udol ◽  
Worawong Slisatkorn ◽  
Prasert Sawasdiwipachai
Keyword(s):  
Cardiac Surgery ◽  
Primary Outcome ◽  
Intervention Group ◽  
Ventilator Weaning ◽  
Control Group ◽  
Early Extubation ◽  
Elective Cardiac Surgery ◽  
Postoperative Intensive Care ◽  
Cardiovascular Care ◽  
Relevant Cost

Objective: To compare successful early extubation rates, complications, and cost before and after the use of anestablished ventilator weaning protocol in patients undergoing elective cardiac surgery.Materials and Methods: Subjects were adult patients undergoing elective cardiac surgery who were clinically stablewithin 2 hours after surgery. The control group underwent conventional ventilator weaning at the discretion of theirattending staff. The intervention group underwent protocol-guided ventilator weaning. The primary outcome wasa successful early extubation (within 6 hours after surgery). Secondary outcomes were complications from weaningto 24 hours after surgery, and the relevant cost related to respiratory and cardiovascular care within 24 hours afteradmission to the postoperative intensive care unit.Results: The primary outcome occurred in 37 out of 65 patients (56.9%) in the intervention group and in 5 out of65 patients (7.7%) in the control group (adjusted odds ratio 20.6; 95% confidence interval 6.7–62.9, p<0.001). Thecomplication rates were not statistically different between the intervention and control groups (26.2% vs. 20.0%,p=0.41). The relevant cost, approximated by the service charges, related to respiratory and cardiovascular care wassignificantly less in the intervention group than in the control group (median 2,491 vs. 2,711 Thai baht, p<0.001).Conclusion: The use of the established ventilator weaning protocol after elective cardiac surgery was associated witha higher rate of successful early extubation and lower cost related to respiratory and cardiovascular care comparedto the conventional practices of ventilator weaning and extubation. The rates of overall complications were notsignificantly different.

scholarly journals Monsel´s solution for first degree perineal bleeding tears treatment: a randomized controlled clinical trial

2020 ◽  
Vol 11 (1) ◽  
Author(s):  
Casale Roberto Antonio ◽  
Varela Silvana
Keyword(s):  
Clinical Trial ◽  
Vaginal Delivery ◽  
Primary Outcome ◽  
Intervention Group ◽  
Active Bleeding ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Wound Infections ◽  
Suture Materials ◽  
Intention To Treat

Introduction: During vaginal delivery, tears can occur in different areas of the lower genital tract. The policy of "restrictive episiotomy" increases anterior perineal trauma, mainly paraurethral tears. The topical application of Monsel´s solution in first degree perineal bleeding tears may benefit patients because of less use of anesthetics, sutures and procedure time. Objective: To determine if the Monsel´s solution stops active bleeding in first degree tears compared to traditional suture. Materials and methods: Randomized clinical trial, carried out at Hospital Nacional "Prof. Alejandro Posadas" from January 2011 to December 2013. 330 patients with recent postpartum vaginal delivery were admitted with a diagnosis of first degree bleeding tears. They were randomized to receive the application of Monsel´s solution, until stopping bleeding (intervention group) or traditional suture (control group). The primary outcome was the stoppage of active bleeding. Secondary outcomes were: patient discomfort with the procedure, practicality of the procedure, alterations in the scarring of the tear and wound infections. Crude and adjusted ORs and 95% CI were calculated. Analysis was done by intention to treat. The study was approved by the Bioethics Committee of the Hospital. Results: Monsel´s solution was effective for the stoppage of active bleeding in 86.7% of first degree bleeding tears. Out of 150 patients randomized to the intervention group, 130 met the primary outcome, ORc 0.04 (95% CI 0.01-0.27)/ORa 0.05 (95% CI 0.01-0.34) Monsel´s solution was safe, because it did not interfere with the scarring process It also offered a protective aspect on wound infections. The procedure was practical and simple for the intervening professionals and, despite being an irritant for the mucous; it was well tolerated by the patients. Conclusion: The Monsel´s solution appears effective, practical and safe for treatment of first degree bleeding tears.

scholarly journals Kinesiotherapy With Exergaming as a Potential Modulator of Epigenetic Marks and Clinical Functional Variables of Older Women: Protocol for a Mixed Methods Study

10.2196/32729 ◽  
2021 ◽  
Vol 10 (10) ◽  
pp. e32729
Author(s):  
Patrícia Paula Bazzanello Henrique ◽  
Fabrízzio Martin Pelle Perez ◽  
Osvaldo Henrique Cemin Becker ◽  
Ericles Andrei Bellei ◽  
Daiana Biduski ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Older Women ◽  
Intervention Group ◽  
Control Group ◽  
Timed Up And Go ◽  
Epigenetic Marks ◽  
Exercise Interventions ◽  
Group A ◽  
Clinical Trials Registry ◽  
The Impact

Background Kinesiotherapy is an option to mitigate worsening neuropsychomotor function due to human aging. Moreover, exergames are beneficial for the practice of physical therapy by older patients. Physical exercise interventions are known to alter the epigenome, but little is known about their association with exergames. Objective We aim to evaluate the effects of kinesiotherapy with exergaming on older women’s epigenetic marks and cognitive ability, as well as on their clinical functional variables. Our hypothesis states that this kind of therapy can elicit equal or even better outcomes than conventional therapy. Methods We will develop a virtual clinic exergame with 8 types of kinesiotherapy exercises. Afterward, we will conduct a 1:1 randomized clinical trial to compare the practice of kinesiotherapy with exergames (intervention group) against conventional kinesiotherapy (control group). A total of 24 older women will be enrolled for 1-hour sessions performed twice a week, for 6 weeks, totaling 12 sessions. We will assess outcomes using epigenetic blood tests, the Montreal Cognitive Assessment test, the Timed Up and Go test, muscle strength grading in a hydraulic dynamometer, and the Game Experience Questionnaire at various stages. Results The project was funded in October 2019. Game development took place in 2020. Patient recruitment and a clinical trial are planned for 2021. Conclusions Research on this topic is likely to significantly expand the understanding of kinesiotherapy and the impact of exergames. To the best of our knowledge, this may be one of the first studies exploring epigenetic outcomes of exergaming interventions. Trial Registration Brazilian Clinical Trials Registry/Registro Brasileiro de Ensaios Clínicos (ReBEC) RBR-9tdrmw; https://ensaiosclinicos.gov.br/rg/RBR-9tdrmw. International Registered Report Identifier (IRRID) DERR1-10.2196/32729

scholarly journals Rational and Design of the SIMULATOR Study: A Multicentre Randomized Study to Assess the Impact of SIMULation-bAsed Training on Transoesophageal echocardiOgraphy leaRning for Cardiology Residents

2021 ◽  
Vol 8 ◽  
Author(s):  
Théo Pezel ◽  
Anne Bernard ◽  
Yoan Lavie Badie ◽  
Julien Dreyfus ◽  
Etienne Audureau ◽  
...  
Keyword(s):  
Randomized Study ◽  
Intervention Group ◽  
Medical Residents ◽  
Control Group ◽  
Traditional Teaching ◽  
Single Center ◽  
Simulation Based ◽  
Simulator Study ◽  
And Performance ◽  
The Impact

Introduction: Simulation-based training in transesophageal echocardiography (TEE) seems promising. However, data are limited to non-randomized or single-center studies. To assess the impact of simulation-based vs. traditional teaching on TEE knowledge and performance for medical residents in cardiology.Materials and Methods: Nationwide prospective randomized multicenter study involving 43 centers throughout France allowing for the inclusion of &gt;70% of all French cardiology residents. All cardiology residents naive from TEE will be included. Randomization with stratification by center will allocate residents to either a control group receiving theoretical knowledge by e-learning only, or to an intervention group receiving two simulation-based training sessions on a TEE simulator in addition.Results: All residents will undergo both a theoretical test (0–100 points) and a practical test on a TEE simulator (0–100 points) before and 3 months after the training. Satisfaction will be assessed by a 5-points Likert scale. The primary outcomes will be to compare the scores in the final theoretical and practical tests between the two groups, 3 months after the completion of the training.Conclusion: Data regarding simulation-based learning in TEE are limited to non-randomized or single-center studies. The randomized multicenter SIMULATOR study will assess the impact of simulation-based vs. traditional teaching on TEE knowledge and performance for medical residents in cardiology, and whether such an educational program should be proposed in first line for TEE teaching.

scholarly journals Effectiveness of a nursing intervention in decreasing the anxiety levels of family members of patients undergoing cardiac surgery: a randomized clinical trial

2016 ◽  
Vol 24 (0) ◽  
Author(s):  
Letícia Hamester ◽  
Emiliane Nogueira de Souza ◽  
Cibele Cielo ◽  
Maria Antonieta Moraes ◽  
Lúcia Campos Pellanda
Keyword(s):  
Clinical Trial ◽  
Cardiac Surgery ◽  
Randomized Clinical Trial ◽  
Family Members ◽  
Intervention Group ◽  
Nursing Intervention ◽  
Control Group ◽  
Waiting Room ◽  
Post Operative Period ◽  
Anxiety Levels

ABSTRACT Objective: to verify the effectiveness of nursing orientation provided to families of patients in the immediate post-operative following cardiac surgery before the first visit to the post-anesthesia care unit, in decreasing anxiety levels, compared to the unit's routine orientation. Method: open randomized clinical trial addressing family members in the waiting room before the first visit in the immediate post-operative period. The family members assigned to the intervention group received audiovisual orientation concerning the patients' conditions at the time and the control group received the unit's routine orientation. Outcome anxiety was assessed using the STAI-State. Results: 210 individuals were included, 105 in each group, aged 46.4 years old on average (±14.5); 69% were female and 41% were the patients' children. The mean score obtained on the anxiety assessment in the intervention group was 41.3±8.6, while the control group scored 50.6±9.4 (p<0.001). Conclusion: a nursing intervention focused on providing guidance to families before their first visit to patients in the immediate post-operative period of cardiac surgery helps to decrease the levels of anxiety of companions, making them feel better prepared for the moment. ReBEC (Brazilian Clinical Trials Registry) and The Universal Trial Number (UTN), No. U1111-1145-6172.

scholarly journals Impact of Modified Transesophageal Echocardiography on Mortality and Stroke after Cardiac Surgery: A Large Cohort Study

2017 ◽  
Vol 2017 ◽  
pp. 1-8
Author(s):  
Wouter W. Jansen Klomp ◽  
Carl G. M. Moons ◽  
Arno P. Nierich ◽  
George J. Brandon Bravo Bruinsma ◽  
Arnoud W. J. van’t Hof ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Transesophageal Echocardiography ◽  
Intervention Group ◽  
Postoperative Mortality ◽  
Control Group ◽  
Aortic Atherosclerosis ◽  
Stroke Incidence ◽  
Relative Risks ◽  
Large Cohort Study ◽  
The Impact

The aim of this study was to investigate the impact of perioperative screening with modified transesophageal echocardiography (A-View method). We compared, in consecutive patients who underwent cardiac surgery between 2006 and 2014, 30-day mortality and in-hospital stroke incidence, operated either with perioperative modified TEE screening (intervention group) or only with conventional TEE screening (control group). Of the 8,605 study patients, modified TEE was applied in 1,391 patients (16.2%). Patients in the intervention group were on average older (71 versus 68 years, p<0.001) and more often females (31.0% versus 28.0%, p<0.001) and had a higher predicted mortality (EuroSCORE I: 5.9% versus 4.0%, p<0.001). The observed 30-day mortality was 2.2% and 2.5% in both groups, respectively, with multivariable and propensity-score adjusted relative risks (RRs) of 0.70 (95% CI: 0.50–1.00, p=0.05) and 0.67 (95% CI: 0.45–0.98, p=0.04). In-hospital stroke was 2.9% and 2.1% in both groups, respectively, with adjusted RRs of 1.03 (95% CI: 0.73–1.45) and 1.01 (95% CI: 0.71–1.43). In patients undergoing cardiac surgery, use of perioperative screening for aortic atherosclerosis with modified TEE was associated with lower postoperative mortality, but not stroke, as compared to patients operated on without such screening.

scholarly journals Interleukin-31 Serum And Pruritus Dimension After Acupuncture Treatment In Hemodialysis Patients: A Randomized Clinical Trial

2021 ◽  
Vol 9 (B) ◽  
pp. 196-201
Author(s):  
Dedi Ardinata ◽  
Rozaimah Zain-Hamid ◽  
Irma. D. Roesyanto-Mahadi ◽  
Hasan Mihardja
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Serum Levels ◽  
Hemodialysis Patients ◽  
Control Group ◽  
Placebo Control ◽  
Limited Information ◽  
Before And After ◽  
The Impact

BACKGROUND: Interleukin (IL)-31 serum levels were significantly higher in hemodialysis patients with pruritus, whereas acupuncture in LI11 was shown to improve symptoms of pruritus. However, there is limited information that IL-31 serum levels that correlate with decreased dimensions of the pruritus after acupuncture in LI11 in a hemodialysis patient. AIM: The aim of the study was to demonstrate the impact of acupuncture in LI11 and IL-31 serum level and its correlation with dimensions of the pruritus in hemodialysis patients. METHODS: A randomized clinical trial has been carried out from August 2019 to December 2019 at H. Adam Malik General Hospital, Medan, Indonesia. Sixty patients underwent hemodialysis who were randomly allocated to two groups, one group got acupuncture in Quchi LI11 (intervention group), and the other group got a placebo (control group). IL-31 serum levels and pruritus were measured before and after 6 weeks of acupuncture in both groups. RESULTS: Acupuncture did not significantly reduce IL-31 (p = 0.931) and decreased dimensions: Degree, duration, disability, and distribution of the pruritus between the intervention group and the control group after 6 weeks of acupuncture in LI11. It can be shown that there is no significant correlation between IL-31 serum levels and dimensions of the pruritus. CONCLUSION: This study demonstrates the effect of acupuncture on reducing dimensions of the pruritus not related to IL-31 serum levels. Identifying the action mechanism of acupuncture to minimize pruritus considerably enhances knowledge of the impacts of acupuncture on reducing pruritus in hemodialysis patients.

scholarly journals Investigating the impact of physical-mental exercises on depression after prederm delivery: a clinical trial

2020 ◽  
pp. 128-138
Keyword(s):  
Clinical Trial ◽  
Intervention Group ◽  
Psychological Trauma ◽  
The Body ◽  
Public Hospitals ◽  
Control Group ◽  
Control Groups ◽  
The Mean ◽  
The Impact ◽  
Stretching Exercises

Background and Aim: Prederm delivery, and the consequences are include premature newborn, hospitalization in the NICU ward, psychological damage to mother and heart family performing low-cost, practical interventions can play an important role in promoting maternal health by to reduce psychological trauma. Therefore, the present study was performed to determine the impact of physical-mental exercises on depression after prederm delivery. Materials and Methods: In this clinical trial, 100 women with prederm delivery 28-36 weeks, it was performed in public hospitals in Mashhad in 2019. Sampling was performed by random blocking method and the subjects were selected by available method and were divided into two control groups (n=50) and intervention (n=50). The intervention group performed stretching exercises as well as meditation by the researcher on the third day after delivery with a frequency of two sessions per week for up to 8 sessions, and the control group received the usual care. Beck's depression questionnaire was completed for both groups in the first 24 hours after delivery and at the end of the study. Statistical analysis of the data was performed by independent t-test, Mann-Whitney and Wilkaxon. Results: The mean score of depression in the intervention and control groups at the end of the study was statistically significant (p≤0.001). The mean score of depression in the intervention group was significant at the beginning and the end of the study (P<0.001). Conclusion: Stretching exercises with a focus on the body after delivery can reduce the rate of depression in mothers with prederm delivery. Key Words: Meditation; Postpartum Depression; prederm delivery; Stretching Exercise

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