Feasibility of conservative fluid administration and deresuscitation compared with usual care in critical illness: the Role of Active Deresuscitation After Resuscitation-2 (RADAR-2) randomised clinical trial

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.

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Effects of mindfulness training programmes delivered by a self-directed mobile app and by telephone compared with an education programme for survivors of critical illness: a pilot randomised clinical trial

Thorax ◽

10.1136/thoraxjnl-2017-211264 ◽

2018 ◽

Vol 74 (1) ◽

pp. 33-42 ◽

Cited By ~ 21

Author(s):

Christopher E Cox ◽

Catherine L Hough ◽

Derek M Jones ◽

Anna Ungar ◽

Wen Reagan ◽

...

Keyword(s):

Clinical Trial ◽

Psychological Distress ◽

Critical Illness ◽

Education Programme ◽

Randomised Clinical Trial ◽

Mobile App ◽

Patient Health Questionnaire ◽

Health Questionnaire ◽

Icu Patients ◽

Patient Health

BackgroundPatients who are sick enough to be admitted to an intensive care unit (ICU) commonly experience symptoms of psychological distress after discharge, yet few effective therapies have been applied to meet their needs.MethodsPilot randomised clinical trial with 3-month follow-up conducted at two academic medical centres. Adult (≥18 years) ICU patients treated for cardiorespiratory failure were randomised after discharge home to 1 of 3 month-long interventions: a self-directed mobile app-based mindfulness programme; a therapist-led telephone-based mindfulness programme; or a web-based critical illness education programme.ResultsAmong 80 patients allocated to mobile mindfulness (n=31), telephone mindfulness (n=31) or education (n=18), 66 (83%) completed the study. For the primary outcomes, target benchmarks were exceeded by observed rates for all participants for feasibility (consent 74%, randomisation 91%, retention 83%), acceptability (mean Client Satisfaction Questionnaire 27.6 (SD 3.8)) and usability (mean Systems Usability Score 89.1 (SD 11.5)). For secondary outcomes, mean values (and 95% CIs) reflected clinically significant group-based changes on the Patient Health Questionnaire depression scale (mobile (−4.8 (−6.6, −2.9)), telephone (−3.9 (−5.6, −2.2)), education (−3.0 (−5.3, 0.8)); the Generalized Anxiety Disorder scale (mobile −2.1 (−3.7, −0.5), telephone −1.6 (−3.0, −0.1), education −0.6 (−2.5, 1.3)); the Post-Traumatic Stress Scale (mobile −2.6 (−6.3, 1.2), telephone −2.2 (−5.6, 1.2), education −3.5 (−8.0, 1.0)); and the Patient Health Questionnaire physical symptom scale (mobile −5.3 (−7.0, −3.7), telephone −3.7 (−5.2, 2.2), education −4.8 (−6.8, 2.7)).ConclusionsAmong ICU patients, a mobile mindfulness app initiated after hospital discharge demonstrated evidence of feasibility, acceptability and usability and had a similar impact on psychological distress and physical symptoms as a therapist-led programme. A larger trial is warranted to formally test the efficacy of this approach.Trial registration numberResults, NCT02701361.

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A Pilot Randomised Clinical Trial of a Novel Approach to Reduce Sedentary Behaviour in Care Home Residents: Feasibility and Preliminary Effects of the GET READY Study

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17082866 ◽

2020 ◽

Vol 17 (8) ◽

pp. 2866 ◽

Cited By ~ 1

Author(s):

Maria Giné-Garriga ◽

Philippa M. Dall ◽

Marlene Sandlund ◽

Javier Jerez-Roig ◽

Sebastien F. M. Chastin ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Usual Care ◽

Sedentary Behaviour ◽

Fear Of Falling ◽

Care Home ◽

Randomised Clinical Trial ◽

Post Intervention ◽

Novel Approach

Care-home residents are among the most sedentary and least active of the population. We aimed to assess the feasibility, acceptability, safety, and preliminary effects of an intervention to reduce sedentary behaviour (SB) co-created with care home residents, staff, family members, and policymakers within a pilot two-armed pragmatic cluster randomized clinical trial (RCT). Four care homes from two European countries participated, and were randomly assigned to control (usual care, CG) or the Get Ready intervention (GR), delivered by a staff champion one-to-one with the care home resident and a family member. A total of thirty-one residents participated (51.6% female, 82.9 (13.6) years old). GR involves six face to face sessions over a 12-week period with goal-oriented prompts for movement throughout. The feasibility and acceptability of the intervention were assessed and adverse events (AEs) were collected. The preliminary effects of the GR on SB, quality of life, fear of falling, and physical function were assessed. Means and standard deviations are presented, with the mean change from baseline to post-intervention calculated along with 95% confidence intervals. The CG smoked more, sat more, and had more functional movement difficulties than the GR at baseline. The GR intervention was feasible and acceptable to residents and staff. No AEs occurred during the intervention. GR participants showed a decrease in daily hours spent sitting/lying (Cohen’s d = 0.36) and an increase in daily hours stepping, and improvements in health-related quality of life, fear of falling, and habitual gait speed compared to usual care, but these effects need confirmation in a definitive RCT. The co-created GR was shown to be feasible and acceptable, with no AEs.

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P3623Integrating depression and acute coronary syndrome care in low-resource hospitals in china: primary results from the I-Care randomised clinical trial

European Heart Journal ◽

10.1093/eurheartj/ehz745.0481 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

Y Wu ◽

X Yu ◽

Y Zhu ◽

C Shi ◽

X Li ◽

...

Keyword(s):

Clinical Trial ◽

Usual Care ◽

Clinical Outcomes ◽

Random Effect ◽

Randomised Clinical Trial ◽

Mean Difference ◽

Hospital Level ◽

Problem Solving Therapy ◽

Risk Factor Management ◽

Coronary Syndrome

Abstract Background Depression and acute coronary syndromes (ACS) are significant public health challenges. Patients with ACS often experience depression, which adversely affects prognosis. Low-cost, sustainable, and effective service models that integrate depression care into the management of ACS patients to reduce depression and improve ACS outcomes are critically needed. Purpose I-CARE study is a multi-center, randomised clinical trial (RCT) to evaluate the efficacy of an 11-month integrated care (IC) intervention compared to usual care (UC) in the management of ACS patients. Methods The I-CARE RCT was conducted between October 2014 and March 2018 in 16 rural Chinese hospitals. A total of 4041 patients with ACS were consecutively enrolled and randomly assigned in a 1:1 ratio to an IC intervention consisting of nurse-led risk factor management, group-based counseling supplemented by individual problem solving therapy and antidepressant medications as needed, or UC. The primary outcome was change in Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 6 and 12 months. Secondary outcomes included incidence of major adverse events (MAEs) after discharge, quality of life (EQ5D), and adherence to ACS secondary prevention medications. Data analysis used a multilevel mixed-effects model with hospital-level and subject-level random-effect intercepts and hospital-level random slope incorporated to adjust for clustering effect. Primary analyses followed the intent-to-treat principle. Results The mean age of the patients was 61±10 years and 63% were men; however, only 3.3% were classified as depressed based upon a cutoff of ≥10 on the PHQ-9, and 26.9% had PHQ-9 scores between 5 to 9 at the baseline. There were no significant differences in patients' clinical characteristics between IC and UC groups. Changes in PHQ-9 scores from baseline to 6- and 12-months did not differ between treatment groups (−1.47 in IC group vs −1.40 in UC group; adjusted mean difference, −0.04; 95% CI, −0.17 to 0.08 at 6-months; −1.62 in IC group vs −1.54 in UC group; adjusted mean difference, −0.06; 95% CI: −0.19 to 0.06 at 12-months).The risk of MAEs after discharge between IC and UC groups also did not differ significantly (42.1% vs 43.1%; p=0.307). Conclusions Results from the I-CARE trial showed that a nurse-coordinated ACS and depression IC intervention did not reduce depression or improve clinical outcomes among patients with ACS compared to usual care controls. The low prevalence of depression was unexpected and may have minimized the potential added benefits of the IC intervention on depression and clinical outcomes compared to UC. Acknowledgement/Funding This study is supported by a grant from the National Institute of Mental Health (R01MH100332).

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