The Effect of Support Surfaces on the Incidence of Pressure Injuries in Critically Ill Patients: A Randomized Clinical Trial

Purpose. To analyze whether a viscoelastic mattress support surface can reduce the incidence of stage 2 pressure injuries compared to a standard hospital mattress with pyramidal overlay in critically ill patients. Method. A randomized clinical trial with intention-to-treat analysis was carried out recruiting patients with Braden scale ≤14 on intensive care unit admission from April 2016 to April 2017. Patients were allocated into two groups: intervention group (viscoelastic mattress) and control group (standard mattress with pyramidal overlay). The level of significance adopted was 5%. Results. A total of 62 patients were included in the study. There was a predominance of males (53%) and the mean age was 67.9 (SD 18.8) years. There were no differences in clinical or severity characteristics between the patients in the control group and the intervention group. Pressure injuries occurred in 35 patients, with a median time of 7 days (ITQ 4–10) from admission. The frequency of pressure injuries was higher in the control group (80.6%) compared to the intervention group (32.2%; p<0.001). Conclusions. Viscoelastic support surfaces reduced the incidence of pressure injuries in moderate or higher risk critically ill patients when compared to pyramidal support surfaces.

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Virtual reality stimulation to reduce the incidence of delirium in critically ill patients: study protocol for a randomized clinical trial

Trials ◽

10.1186/s13063-021-05090-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Aileen C. Naef ◽

Marie-Madlen Jeitziner ◽

Stephan M. Gerber ◽

Béatrice Jenni-Moser ◽

René M. Müri ◽

...

Keyword(s):

Clinical Trial ◽

Virtual Reality ◽

Randomized Clinical Trial ◽

Critically Ill ◽

Critically Ill Patients ◽

Movement Patterns ◽

Control Group ◽

Immersive Virtual Reality ◽

Head Mounted Display ◽

Noise Cancelling

Abstract Background Delirium has been long considered as a major contributor to cognitive impairments and increased mortality following a critical illness. Pharmacologic and non-pharmacologic strategies are used against delirium in the intensive care unit (ICU), despite these strategies remaining controversial. Previous studies have shown the feasibility of using virtual reality within the ICU setting, and we propose to use this technology to investigate the effect of immersive virtual reality stimulation on the incidence of delirium in the ICU. Moreover, we propose to use motion sensors to determine if patient movement patterns can lead to early prediction of delirium onset. Methods This study is conducted as a randomized clinical trial. A total of 920 critically ill patients in the ICU will participate. The control group will receive standard ICU care, whereas the intervention group will, in addition to the standard ICU care, receive relaxing 360-degree immersive virtual reality content played inside a head-mounted display with noise-cancelling headphones, three times a day. The first 100 patients, regardless of their group, will additionally have their movement patterns recorded using wearable and ambient sensors. Follow-up measurements will take place 6 months after discharge from the ICU. Discussion Delirium is widely present within the ICU setting but lacks validated prevention and treatment strategies. By providing patients with virtual reality stimulation presented inside a head-mounted display and noise-cancelling headphones, participants may be isolated from disturbances on an ICU. It is believed that by doing so, the incidence of delirium will be decrease among these patients. Moreover, identifying movement patterns associated with delirium would allow for early detection and intervention, which may further improve long-term negative outcomes associated with delirium during critical care. Trial registration ClinicalTrials.gov NCT04498585. Registered on August 3, 2020

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The Effect of Vitamin C on Pathological Parameters and Survival Duration of Critically Ill Coronavirus Disease 2019 Patients: A Randomized Clinical Trial

Frontiers in Immunology ◽

10.3389/fimmu.2021.717816 ◽

2021 ◽

Vol 12 ◽

Author(s):

Nazanin Majidi ◽

Faezeh Rabbani ◽

Somayeh Gholami ◽

Maryam Gholamalizadeh ◽

Fatemeh BourBour ◽

...

Keyword(s):

Clinical Trial ◽

Vitamin C ◽

Critically Ill ◽

Critically Ill Patients ◽

Intervention Group ◽

Survival Duration ◽

Control Group ◽

Clinical Trial Registration ◽

Arterial Blood ◽

Vitamin C Supplementation

IntroductionVitamin C has been reported to have beneficial effects on patients with coronavirus disease 2019 (COVID-19). This study aimed to investigate the effect of vitamin C supplementation on pathological parameters and survival duration of critically ill patients with COVID-19.MethodsThis clinical trial was conducted on 120 hospitalized critically ill patients infected with COVID-19. The intervention group (n = 31) received one capsule of 500 mg of vitamin C daily for 14 days. The control group (n = 69) received the same nutrition except for vitamin C supplements. Measurement of pathological and biochemical parameters was performed at baseline and after 2 weeks of the intervention.ResultsFollowing 2 weeks of vitamin C supplementation, the level of serum K was significantly lower in the patients compared with the control group (3.93 vs. 4.21 mEq/L, p < 0.01). Vitamin C supplementation resulted in a higher mean survival duration compared with that of the control group (8 vs. 4 days, p < 0.01). There was a linear association between the number of days of vitamin C intake and survival duration (B = 1.66, p < 0.001). The vitamin C supplementation had no effect on blood glucose, mean arterial pressure, arterial blood gas (ABG) parameters, Glasgow Coma Scale (GCS), kidney function, cell blood count (CBC), hemoglobin (Hb), platelet (Plt), partial thromboplastin time (PTT), albumin, hematocrit (Hct), and other serum electrolytes including sodium (Na), calcium, and phosphorus (P).ConclusionThe present study demonstrated the potential of vitamin C supplementation in enhancing the survival duration of critically ill patients with COVID-19.Clinical Trial Registrationhttps://www.irct.ir/trial/55074, identifier IRCT20151226025699N5

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Effects of fenugreek seed powder on stress-induced hyperglycemia and clinical outcomes in critically ill patients: A randomized clinical trial

Biomedical Research and Therapy ◽

10.15419/bmrat.v5i9.476 ◽

2018 ◽

Vol 5 (9) ◽

pp. 2664-2670

Author(s):

Akram Kooshki ◽

Zaher Khazaei ◽

Mojtaba Rad ◽

Azam Zarghi ◽

Akram Chanbari Mogaddam

Keyword(s):

Clinical Trial ◽

Critically Ill ◽

Critically Ill Patients ◽

Intervention Group ◽

Routine Care ◽

Wilcoxon Test ◽

Apache Ii Score ◽

Control Group ◽

Controlled Clinical Trial ◽

Fenugreek Seed

Introduction: Stress-induced hyperglycemia (SIH) is commonly observed in critically ill patients and associated with poor clinical outcome for patients. Fenugreek seed powder has long been known as an anti-diabetic drug since its pharmaceutical properties were demonstrated. Materials: The study herein was a parallel, randomized controlled clinical trial consisting of 60 adult patients randomly divided into 2 groups (n=30 per group). The study was conducted in Sabzevar, Iran in April 2015. The intervention group received 3 g of fenugreek seed powder by gavage, twice a day, in addition to routine care. The control group received only routine care. In the beginning, a daily evaluation of fasting and postprandial blood sugar was conducted for 10 days. Secondary components (prevalence of pneumonia; length of intensive care unit (ICU) stay, length of hospital stay, ventilator days, APACHE II score, and mortality rate) were measured until the time of hospital discharge or death. Data were analyzed via SPSS v.20 using Student's t-test (paired and unpaired), chi-square test, repeated measure ANOVA, and Wilcoxon test. Results: In during 10 days of treatment, there was a significant fall in mean glucose levels in 2 groups. However, this improve was more significant in Intervention group in compared to control group (p<0.001). Conclusion: The present study suggests that daily diet with fenugreek seeds can be used as an add-on therapy with other medications in the management of SIH in critically ill patients.

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Effects of a diuretic adjustment algorithm protocol on heart failure admissions: A randomized clinical trial

Journal of Telemedicine and Telecare ◽

10.1177/1357633x211009640 ◽

2021 ◽

pp. 1357633X2110096

Author(s):

Maria KEF Feijó ◽

Karen Brasil Ruschel ◽

Daniela Bernardes ◽

Eduarda B Ferro ◽

Luis E Rohde ◽

...

Keyword(s):

Clinical Trial ◽

Emergency Department ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Heart Association ◽

Functional Class ◽

Emergency Department Visits ◽

Control Group ◽

Point Change ◽

Clinical Instability

Introduction The aim of this study was to evaluate the effectiveness of a diuretic adjustment algorithm (DAA) in maintaining clinical stability and reducing HF readmissions using telemonitoring Technologies. Methods Randomized clinical trial of patients with an indication for furosemide dose adjustment during routine outpatient visits. In the intervention group (IG), the diuretic dose was adjusted according to the DAA and the patients received telephone calls for 30 days. In the control group (CG), the diuretic dose was adjusted by a physician at baseline only. Co-primary outcomes were hospital readmission and/or emergency department visits due to decompensated HF within 90 days, and a 2-point change in the Clinical Congestion Score and/or a deterioration in New York Heart Association functional class within 30 days. Results A total of 206 patients were included. Most patients were male ( n=119; 58%), with a mean age of 62 (SD 13) years. Four patients (2%) in the IG and 14 (7%) in the CG were hospitalized for HF (odds ratio (OR) 0.31 (0.10–0.91); p=0.04). Multivariate analysis showed a reduction of 67% in readmissions and/or emergency department visits due to decompensated HF in the IG compared with the CG (95% CI 0.13–0.88; p=0.027). Regarding the combined outcome of HF readmission and/or emergency department visits or clinical instability, the IG had 20% fewer events than the CG within 30 days (IG: n=48 (23%), CG: n=70 (34%); OR 0.80 (0.63–0.93); p=0.03). Discussion Using DAA improved the combined outcome in these outpatients, with favorable and significant results that included a reduction in HF admissions and in clinical instability. (NCT02068937)

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Impact of ascorbic acid in reducing the incidence of vancomycin associated nephrotoxicity in critically ill patients: A preliminary randomized controlled trial

F1000Research ◽

10.12688/f1000research.55619.1 ◽

2021 ◽

Vol 10 ◽

pp. 929

Author(s):

Nouran Hesham El-Sherazy ◽

Naglaa Samir Bazan ◽

Sara Mahmoud Shaheen ◽

Nagwa A. Sabri

Keyword(s):

Ascorbic Acid ◽

Critically Ill ◽

Critically Ill Patients ◽

Statistical Significance ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Control Groups ◽

The Absolute ◽

And Control

Background Antioxidants show nephroprotective effect against vancomycin associated nephrotoxicity (VAN) in animals. This study aimed to assess the ascorbic acid nephro-protective role against VAN clinically. Methods Forty-one critically ill patients were randomly assigned to one of two groups: intervention group (vancomycin IV plus ascorbic acid, n=21) or control group (vancomycin IV only, n=20). Primary outcomes were the incidence of VAN and the absolute change in creatinine parameters, while mortality rate was the secondary outcome. Nephrotoxicity was defined as an increase in serum creatinine (S.cr) by at least 0.5 mg/dL or 50% of baseline for at least two successive measurements. This study is registered at Clinicaltrials.gov (NCT03921099), April 2019. Results Mean absolute S.cr increase was significant when compared between both groups, P-value = 0.036, where S.cr increased by 0.05(0.12) and 0.34(0.55) mg/dL in the intervention and control groups, respectively. Mean absolute Cr.cl decline was significant when compared between both groups, P-value = 0.04, where Cr.cl was decreased by 5.9(17.8) and 22.3(30.4) ml/min in the intervention and control groups, respectively. Incidence of VAN was 1/21(4.7%) versus 5/20(25%) in the intervention and control groups, respectively (RR: 0.19; CI: 0.024–1.49; P-value = 0.093). Mortality was higher in the control group; however, it was not statistically significant, P-value = 0.141. Conclusion Co-administration of ascorbic acid with vancomycin preserved renal function and reduced the absolute risk of VAN by 20.3%, however, the reduction in VAN incidence didn’t reach statistical significance level. Further large multicenter prospective trials are recommended.

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Trisodium citrate 4% versus heparin as a catheter lock for non-tunneled hemodialysis catheters in critically ill patients: a multicenter, randomized clinical trial

Annals of Intensive Care ◽

10.1186/s13613-019-0553-4 ◽

2019 ◽

Vol 9 (1) ◽

Cited By ~ 5

Author(s):

Jean-Pierre Quenot ◽

◽

Julie Helms ◽

Abderrahmane Bourredjem ◽

Auguste Dargent ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Critically Ill ◽

Critically Ill Patients ◽

Trisodium Citrate ◽

Catheter Lock

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Physical methods for the treatment of fever in critically ill patients: a randomized controlled trial

Revista da Escola de Enfermagem da USP ◽

10.1590/s0080-623420160000600016 ◽

2016 ◽

Vol 50 (5) ◽

pp. 823-830 ◽

Cited By ~ 3

Author(s):

Patrícia de Oliveira Salgado ◽

Ludmila Christiane Rosa da Silva ◽

Priscila Marinho Aleixo Silva ◽

Tânia Couto Machado Chianca

Keyword(s):

Body Temperature ◽

Critically Ill ◽

Critically Ill Patients ◽

Intervention Group ◽

Tympanic Temperature ◽

Control Group ◽

Physical Methods ◽

Group I ◽

Significant Difference ◽

Ice Pack

Abstract OBJECTIVE To evaluate the effects of physical methods of reducing body temperature (ice pack and warm compression) in critically ill patients with fever. METHOD A randomized clinical trial involving 102 adult patients with tympanic temperature ≥ 38.3°C of an infectious focus, and randomized into three groups: Intervention I - ice pack associated with antipyretic; Intervention II - warm compress associated with antipyretic; and Control - antipyretic. Tympanic temperature was measured at 15 minute intervals for 3 hours. The effect of the interventions was evaluated through the Mann-Whitney test and Survival Analysis. "Effect size" calculation was carried out. RESULTS Patients in the intervention groups I and II presented greater reduction in body temperature. The group of patients receiving intervention I presented tympanic temperature below 38.3°C at 45 minutes of monitoring, while the value for control group was lower than 38.3°C starting at 60 minutes, and those who received intervention II had values lower than 38.3°C at 75 minutes of monitoring. CONCLUSION No statistically significant difference was found between the interventions, but with the intervention group I patients showed greater reduction in tympanic temperature compared to the other groups. Brazilian Registry of Clinical Trials: RBR-2k3kbq

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Effect of prenatal recommendations of Traditional Persian Medicine on obstetric outcomes: a randomized clinical trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2017-0085 ◽

2018 ◽

Vol 15 (3) ◽

Author(s):

Mansoor Keshavarz ◽

Maryam Kashanian ◽

Soodabeh Bioos ◽

Yasaman Vazani

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Active Phase ◽

Obstetric Outcomes ◽

Control Group ◽

Control Groups ◽

Persian Medicine ◽

Traditional Persian Medicine ◽

And Control

Abstract Background Traditional Persian Medicine (TPM) is an ancient medical system that provides suggestions to improve the health of mothers and children during pregnancy and labor. Persian physicians believed that these instructions made labor easier, safer, and less painful. Methods The present randomized clinical trial was conducted among women at 33–38 weeks of pregnancy in Tehran, Iran. TPM instructions consisted of diet, bathing, and application of oil from the 38th week of pregnancy to the onset of labor. The primary outcome was the duration of the active phase of labor. Results The mean duration of the active phase was 331.60 ± 151.48 min for the intervention group and 344.40 ± 271.46 min for the control groups, but it was not statistically significant. The active phase was significantly shorter in women who had better compliance (p=0.03). The need for oxytocin augmentation was 53.3% in the control group and 38.5% in the intervention group (p=0.17). The rate of perineal infection was 13% in the control group and 0% in the intervention group (p=0.11). Conclusions The active phase was not different in the intervention and control groups, but it was shorter in compliant women. It is possible that prolonged use of these recommendations in combination with a sitz baths and a larger sample size could result in more significant outcomes.

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