scholarly journals Can Cardiopulmonary Rehabilitation Facilitate Weaning of Extracorporeal Membrane Oxygenation (CaRe-ECMO)? Study Protocol for a Prospective Multidisciplinary Randomized Controlled Trial

2022 ◽  
Vol 8 ◽  
Author(s):  
Yu Zheng ◽  
Hao Sun ◽  
Yong Mei ◽  
Yongxia Gao ◽  
Jinru Lv ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Critical Illness ◽  
Extracorporeal Membrane Oxygenation ◽  
Usual Care ◽  
Control Group ◽  
Randomized Controlled ◽  
Membrane Oxygenation ◽  
Secondary Outcomes ◽  
Ecmo Therapy

Background: Mortality of patients suffering from critical illness has been dramatically improved with advanced technological development of extracorporeal membrane oxygenation (ECMO) therapy. However, the majority of ECMO-supported patients failed to wean from ECMO therapy. As one of several options, cardiopulmonary rehabilitation serves as effective intervention in the improvement of cardiovascular and respiratory function in various major critical illness. Nonetheless, its role in facilitating ECMO weaning has not yet been explored. The purpose of this study is to investigate the effectiveness of cardiopulmonary rehabilitation on rate of ready for ECMO weaning in ECMO-supported patients (CaRe-ECMO).Methods: The CaRe-ECMO trial is a randomized controlled, parallel group, clinical trial. This trial will be performed in a minimum number of 366 ECMO-supported eligible patients. Patients will be randomly assigned to either: (1) the CaRe-ECMO group, which will be treated with usual care including pharmacotherapy, non-pharmacotherapy, and specific nursing for ECMO therapy and the CaRe-ECMO program; or (2) the control group, which will receive usual care only. The CaRe-ECMO program consists of protocolized positioning, passive range of motion (PROM) training, neuromuscular electrical stimulation (NMES), surface electrical phrenic nerve stimulation (SEPNS), and pulmonary rehabilitation. The primary outcome of the CaRe-ECMO trial is the rate of ready for ECMO weaning at CaRe-ECMO day 7 (refers to 7 days after the CaRe-ECMO program initiation). Secondary outcomes include rate of ECMO and mechanical ventilation weaning, total length in day of ready for ECMO weaning, ECMO weaning and mechanical ventilation, all-cause mortality, rate of major post-ECMO complications, ECMO unit length of stay (LOS) and hospital LOS, total cost for hospitalization, cerebral performance category (CPC), activities of daily living (ADL), and health-related quality of life (HRQoL).Discussion: The CaRe-ECMO is designed to answer the question “whether cardiopulmonary rehabilitation can facilitate weaning of ECMO (CaRe-ECMO).” Should the implementation of the CaRe-ECMO program result in superior primary and secondary outcomes as compared to the controls, specifically the add-on effects of cardiopulmonary rehabilitation to the routine ECMO practice for facilitating successful weaning, the CaRe-ECMO trial will offer an innovative treatment option for ECMO-supported patients and meaningfully impact on the standard care in ECMO therapy.Clinical Trial Registration:ClinicalTrials.gov, identifier: NCT05035797.

Effectiveness of spiritual care using spiritual pain assessment sheet for advanced cancer patients: A pilot non-randomized controlled trial

2019 ◽  
Vol 17 (1) ◽  
pp. 46-53
Author(s):  
Kaori Ichihara ◽  
Sayako Ouchi ◽  
Sachiko Okayama ◽  
Fukiko Kinoshita ◽  
Mitsunori Miyashita ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Pain Assessment ◽  
Spiritual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Assessment Sheet

AbstractObjectiveTo obtain preliminary knowledge to design a randomized controlled trial to clarify the effects of spiritual care using the Spiritual Pain Assessment Sheet (SpiPas).MethodThe study was designed as a nonrandomized controlled trial. The study took place between January 2015 and July 2015 in a hematology and oncology ward and two palliative care units in Japan. Among 54 eligible patients with advanced cancer, 46 were recruited (24 in the control group vs. 22 in the intervention group). The intervention group received spiritual care using SpiPas and usual care; the control group received usual care. The primary outcome was the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp). The secondary outcomes were the Hospital Anxiety and Depression Scale (HADS) and Comprehensive Quality of Life Outcome (CoQoLo).ResultA total of 33 (72%) and 23 (50%) patients completed 2- and 3-week follow-up evaluations, respectively. The differences in the changes during 2 weeks in total scores of FACIT-Sp and HADS were significant (95% confidence intervals, 3.65, 14.4, p < 0.01; –11.2 to –1.09, p = .02, respectively). No significant changes were observed in the total score of CoQoLo.Significance of resultsSpiritual care using the SpiPas might be useful for improving patient spiritual well-being. This controlled clinical trial could be performed and a future clinical trial is promising if outcomes are obtained within 2 weeks.

scholarly journals Efficacy and safety of Bujing Yishi tablet for glaucoma with controlled IOP: study protocol for a multi-centre randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Hongji Liu ◽  
Xiang Li ◽  
Zongduan Zhang ◽  
Jieping Zeng ◽  
Yan Dai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intraocular Pressure ◽  
Chinese Medicine ◽  
Visual Function ◽  
Vision Loss ◽  
Control Group ◽  
Therapeutic Effects ◽  
Randomized Controlled ◽  
First Choice ◽  
Secondary Outcomes

Abstract Background As an irreversible, intractable disease with vision loss, glaucoma leads to permanent and progressive damage of visual function. Lowering high intraocular pressure (HIOP) is the first choice for treating glaucoma; however, the control of HIOP is not enough to prevent progressive vison loss. Currently, the therapies to treat glaucoma with controlled IOP (GPCI) are unsatisfactory. Chinese medicine is effective for improving visual function in patients with GPCI. Bujing Yishi tablets (BJYSP) have been the standard preparation for treating GPCI in our hospital for decades. However, no rigorous randomized controlled clinical studies have investigated its effects and safety. Methods This study will be a 6-month, multicenter, stratified trial following a prospective, randomized, open-label, blinded endpoint (PROBE) protocol. A total of 216 eligible GPCI patients aged 18–75 years will be stratified according to the early, moderate, and advanced stages of glaucoma. After stratifying, the participants will be randomly assigned to the BJYSP group or control group at a ratio of 1:1. Following randomization, participants in the BJYSP group and control group will receive BJYSP and mecobalamin tablets, respectively, for the same 6-month period. The primary outcomes will include the best-corrected visual acuity (BCVA), visual field assessment, visual evoked potential (VEP) test, and Heidelberg retina tomography II (HRT II); the secondary outcomes will include intraocular pressure (IOP) and Traditional Chinese medicine (TCM) clinical symptom scales. The primary and secondary outcomes will be measured at baseline and 8, 16, and 24 weeks thereafter. Safety assessments will also be evaluated at baseline and 12 and 24 weeks thereafter. Discussion This study will be a standardized, scientific, clinical trial designed to evaluate the therapeutic effects and safety of BJYSP as a novel therapeutic strategy for improving visual function in patients with GPCI. Trial registration Chinese Clinical Trial Registry, ChiCTR1800016431. Registered on 1 June 2018.

“Awake” Extracorporeal Membrane Oxygenation as a Bridge to Lung Transplant

2016 ◽  
Vol 27 (3) ◽  
pp. 293-300 ◽  
Author(s):  
Sara K. Kearns ◽  
Omar O. Hernandez
Keyword(s):  
Mechanical Ventilation ◽  
Extracorporeal Membrane Oxygenation ◽  
Patient Population ◽  
Lung Transplant ◽  
Relevant Literature ◽  
Significant Problem ◽  
Membrane Oxygenation ◽  
Number Of Patients ◽  
Indications And Complications ◽  
Ecmo Therapy

Mortality of patients awaiting lung transplant remains a significant problem as the number of patients on the waiting list far surpasses the number of donor organs available. Interest in the use of “awake” extracorporeal membrane oxygenation (ECMO) as a bridge to lung transplant has emerged because this strategy offers several benefits over mechanical ventilation. This article provides a review of relevant literature and discusses indications and complications of awake ECMO therapy, cannulation strategies, and nursing considerations for this patient population.

scholarly journals Prior Antiplatelet Therapy and Stroke Risk in Critically Ill Patients Undergoing Extracorporeal Membrane Oxygenation

2021 ◽  
Vol 18 (16) ◽  
pp. 8679
Author(s):  
Tak-Kyu Oh ◽  
In-Ae Song ◽  
Sol-Yi Lee ◽  
Hey-Ran Choi
Keyword(s):  
Extracorporeal Membrane Oxygenation ◽  
Antiplatelet Therapy ◽  
Lower Incidence ◽  
Population Based ◽  
Control Group ◽  
Multivariable Logistic Regression Analysis ◽  
Stroke Incidence ◽  
Membrane Oxygenation ◽  
Number Of Patients ◽  
Ecmo Therapy

We aimed to investigate whether prior exposure to antiplatelet therapy (anti-PLT) was associated with stroke incidence after the initiation of extracorporeal membrane oxygenation (ECMO) therapy. We conducted a population-based cohort study based on health records obtained from the National Health Insurance Service database in South Korea. Adult patients (aged ≥ 18 years) who underwent ECMO therapy in the intensive care unit during 2009–2018 were enrolled. In total, 17,237 patients who underwent ECMO therapy were included; stroke occurred in 779 (4.5%) of 17,237 patients within 7 days of initiating the ECMO therapy. The number of patients in the anti-PLT and control groups was 3909 (22.7%) and 13,328 (77.3%), respectively. In the multivariable logistic regression analysis, the anti-PLT group showed 33% lower incidence of stroke than the control group (odds ratio (OR): 0.67, 95% confidence interval (CI): 0.55–0.82; p < 0.001). The cardiovascular group showed 35% lower incidence of stroke than the control group (OR: 0.65, 95% CI: 0.52–0.78; p < 0.001), whereas the respiratory group (p = 0.821) and the other group (p = 0.705) did not show any significant association. Prior anti-PLT therapy was associated with a lower incidence of stroke within 7 days of initiating ECMO therapy, which was more evident in the cardiovascular group.

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

scholarly journals Chronic respiratory disease and survival outcomes after extracorporeal membrane oxygenation

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Tak Kyu Oh ◽  
Hyoung-Won Cho ◽  
Hun-Taek Lee ◽  
In-Ae Song
Keyword(s):  
Respiratory Failure ◽  
Extracorporeal Membrane Oxygenation ◽  
Lung Disease ◽  
Respiratory Disease ◽  
Chronic Respiratory Disease ◽  
Newly Diagnosed ◽  
Membrane Oxygenation ◽  
Obstructive Sleep ◽  
All Cause Mortality ◽  
Ecmo Therapy

Abstract Background Quality of life following extracorporeal membrane oxygenation (ECMO) therapy is an important health issue. We aimed to describe the characteristics of patients who developed chronic respiratory disease (CRD) following ECMO therapy, and investigate the association between newly diagnosed post-ECMO CRDs and 5-year all-cause mortality among ECMO survivors. Methods We analyzed data from the National Health Insurance Service in South Korea. All adult patients who underwent ECMO therapy in the intensive care unit between 2006 and 2014 were included. ECMO survivors were defined as those who survived for 365 days after ECMO therapy. Chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease, lung cancer, lung disease due to external agents, obstructive sleep apnea, and lung tuberculosis were considered as CRDs. Results A total of 3055 ECMO survivors were included, and 345 (11.3%) were newly diagnosed with CRDs 365 days after ECMO therapy. The prevalence of asthma was the highest at 6.1% (185). In the multivariate logistic regression, ECMO survivors who underwent ECMO therapy for acute respiratory distress syndrome (ARDS) or respiratory failure had a 2.00-fold increase in post-ECMO CRD (95% confidence interval [CI]: 1.39 to 2.89; P < 0.001). In the multivariate Cox regression, newly diagnosed post-ECMO CRD was associated with a 1.47-fold (95% CI: 1.17 to 1.86; P = 0.001) higher 5-year all-cause mortality. Conclusions At 12 months after ECMO therapy, 11.3% of ECMO survivors were newly diagnosed with CRDs. Patients who underwent ECMO therapy for ARDS or respiratory failure were associated with a higher incidence of newly diagnosed post-ECMO CRD compared to those who underwent ECMO for other causes. Additionally, post-ECMO CRDs were associated with a higher 5-year all-cause mortality. Our results suggest that ECMO survivors with newly diagnosed post-ECMO CRD might be a high-risk group requiring dedicated interventions.

scholarly journals Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shicheng Wang ◽  
Wensheng Wang ◽  
Long Shao ◽  
Jing Ling
Keyword(s):  
Clinical Trial ◽  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Pain Control ◽  
Controlled Trial ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Total Knee ◽  
Postoperative Residual

Abstract Background Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group. Methods This randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. Discussion This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn) registration number: ChiCTR2000031674. Registered 07 April 2020.

Rest ventilator management in children on veno-venous extracorporeal membrane oxygenation

2021 ◽  
pp. 039139882199938
Author(s):  
Matthew L Friedman ◽  
Samer Abu-Sultaneh ◽  
James E Slaven ◽  
Christopher W Mastropietro
Keyword(s):  
Mechanical Ventilation ◽  
Extracorporeal Membrane Oxygenation ◽  
Life Support ◽  
Arterial Oxygen Saturation ◽  
Peak Inspiratory Pressure ◽  
Conventional Mechanical Ventilation ◽  
Arterial Oxygen ◽  
Multivariable Logistic Regression Analysis ◽  
Membrane Oxygenation ◽  
Ventilator Management

Background: We aimed to use the Extracorporeal Life Support Organization registry to describe the current practice of rest mechanical ventilation setting in children receiving veno-venous extracorporeal membrane oxygenation (V-V ECMO) and to determine if relationships exist between ventilator settings and mortality. Methods: Data for patients 14 days to 18 years old who received V-V ECMO from 2012-2016 were reviewed. Mechanical ventilation data available includes mode and settings at 24 h after ECMO cannulation. Multivariable logistic regression analysis was performed to determine if rest settings were associated with mortality. Results: We reviewed 1161 subjects, of which 1022 (88%) received conventional mechanical ventilation on ECMO. Rest settings, expressed as medians (25th%, 75th%), are as follows: rate 12 breaths/minute (10, 17); peak inspiratory pressure (PIP) 22 cmH2O (20,27); positive end expiratory pressure (PEEP) 10 cmH2O (8, 10); and fraction of inspired oxygen (FiO2) 0.4 (0.37, 0.60). Survival to discharge was 68%. Higher ventilator FiO2 (odds ratio:1.13 per 0.1 increase, 95% confidence interval:1.04, 1.23), independent of arterial oxygen saturation, was associated with mortality. Conclusions: Current rest ventilator management for children receiving V-V ECMO primarily relies on conventional mechanical ventilation with moderate amounts of PIP, PEEP, and FiO2. Further study on the relationship between FiO2 and mortality should be pursued.

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.

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