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Statistical analysis
SECONDARY
A previous study showed a 6.5% mean risk of an AF episode during a 1-day period and 16.7% mean risk of at least one AF episode during a 7-day period [Efficacy analysis was conducted on the full analysis set (FAS), which included all patients who met the inclusion criteria but not the exclusion criteria. Patients who di...
PMC9955627
Results
Patients were registered at the University of Tsukuba Hospital from August 2018 to December 2019. The follow-up period ended in April 2020.
PMC9955627
Study population
Of the 72 patients who consented to participate, 67 completed the study, 4 withdrew because of scheduling problems, and 1 withdrew without providing a reason. The patients were randomly assigned to group 1 (n = 35), which started the study using the Garment ECG with textile electrode for 2 weeks and then the Holter ECG...
PMC9955627
Patient background
The mean age was 63.1±10.6 years old, and 53 (79%) were men. There were 46 patients (69%) with paroxysmal AF, 18 (27%) with persistent AF, and 3 (4%) with long-standing persistent AF. Underbust circumference averaged 92.0±9.1 cm, appropriate for the available sizes (Small, Medium, and Large) of the Garment ECG. Most pa...
PMC9955627
Patient characteristics.
ATRIAL FIBRILLATION
AF, atrial fibrillation; BNP, B-type natriuretic peptide; EF, ejection fraction; eGFR, estimated glomerular filtration rate; LAD, left anterior descending artery; LAVI, left atrial volume index; PVI, pulmonary vein isolation; SD, standard deviation.
PMC9955627
Efficacy
RECURRENCE
The 2-week Garment ECG monitoring detected 12 patients (18%) with AF recurrence, of whom only 4 were detected by 24-hour Holter ECG (6%, p = 0.008) (
PMC9955627
AF occurrences during the follow-up period.
ATRIAL FIBRILLATION
A, AF occurrences in 12 relapsed patients. B, Data from 5 patients who had AF on the first day of Garment ECG measurements. * Of the 12 patients, 4 also showed AF on the Holter 24-hour ECG. AF, atrial fibrillation; ECG, electrocardiogram.
PMC9955627
AF duration in the Garment ECG measurement period.
ATRIAL FIBRILLATION
AF, atrial fibrillation; ECG, electrocardiogram.
PMC9955627
Results from questionnaire on wearability of the garment ECG device (secondary endpoint).
PACS, PREMATURE ATRIAL CONTRACTIONS
The Holter 24-hour ECG demonstrated a slightly higher frequency of premature atrial contractions (PACs) than the 2-week Garment ECG (0.09% [IQR 0.03–0.48%] versus 0.09% [0.03–0.33%], p = 0.014) (
PMC9955627
Safety
redness, erosion
ADVERSE EVENTS, EROSION, SCAR
There were no serious adverse events or unexpected adverse events with either monitoring system. The expected effects on the skin were: redness (n = 2, 3%), erosion (n = 0, 0%), and scar (n = 0, 0%) for 2-week Garment ECG; and redness (n = 0, 0%), erosion (n = 0, 0%), and scar (n = 0, 0%) for 24-hour Holter ECG.
PMC9955627
Discussion
skin irritation, AF
EVENTS, RECURRENCE, PACS
A Garment ECG using hitoeLong-term ECG monitoring options for AF are being explored using implantable devices and non-invasive external recorders. However, implantable devices are expensive and not covered by health insurance, and non-invasive recorders often provide false positives or are otherwise unreliable [In the ...
PMC9955627
Supporting information
PMC9955627
CONSORT 2010 checklist of information to include when reporting a randomised trial*.
(DOC)Click here for additional data file.
PMC9955627
Study protocol.
(DOCX)Click here for additional data file.We thank all the patients who participated in this study and our hospital staff at the physiological laboratory.
PMC9955627
Abbreviations
Atrial fibrillationconfidence intervalelectrocardiogramfull analysis setimplantable loop recorderinterquartile rangeJapan Registry of Clinical Trialspoly(3,4-ethylenedioxythiophene) poly(styrenesulfonate)ACReSS, University Hospital Clinical Trial Alliance Clinical Research Support System)
PMC9955627
References
PMC9955627
Background
hypertension
HYPERTENSION
This randomized controlled trial was performed to observe the effect of remimazolam with sufentanil on hemodynamics during anesthetic induction in elderly patients with mild hypertension undergoing orthopedic surgery of the lower limbs.
PMC10500846
Methods
bradycardia, nausea, vomiting, pain, hypotension
ADVERSE EVENTS
Sixty elderly patients were randomly assigned to undergo general anesthesia with intravenous injection of either remimazolam besylate (25 mg/vial, batch number 10T11011; Yichang Humanwell Pharmaceutical Co., Ltd., Yichang, China) at 0.2 mg/kg (Group R, n = 30) or propofol at 1.5 mg/kg (Group P, n = 30). Both injections...
PMC10500846
Results
ADVERSE EVENTS, ADVERSE EVENT
The MAP, HR, CO, and CI at T1, T2, T3, and T4 were significantly higher in Group R than P, while SVR was significantly lower in Group R than P (P < 0.05). In Group P, the MAP, HR, CO, and CI were significantly lower and the SVR was significantly higher at T1, T2, T3, and T4 than at T0 (P < 0.05). Adverse events occurre...
PMC10500846
Conclusion
ADVERSE REACTIONS, HYPERTENSION
Remimazolam combined with sufentanil for general anesthesia induction has the advantages of small hemodynamic fluctuations, stable circulation, and few adverse reactions, making it suitable for elderly patients with mild hypertension.
PMC10500846
Trial registration
Chinese Clinical Trial Registry (ChiCTR2300069224, 10/03/2023).
PMC10500846
Keywords
PMC10500846
Background
bradycardia, arrhythmia, Hypertension, hypotension, hypertension
ARRHYTHMIA, HYPERTENSION, HYPERTENSION, COMPLICATIONS
With the aging of the population, increasing numbers of elderly patients need surgical treatment. Hypertension is very common in elderly patients. Because elderly patients with hypertension generally have poor vascular elasticity, declining cardiovascular reserve function, and weakening of compensatory ability, hemodyn...
PMC10500846
Methods
PMC10500846
Clinical data
bradycardia, mental illness, liver and kidney dysfunction, arrhythmia, hypertension
ATRIOVENTRICULAR BLOCK, HYPERTENSION, ARRHYTHMIA, ESSENTIAL HYPERTENSION
This study was approved by the Medical Ethics Committee of The Sixth Affiliated Hospital of Wenzhou Medical University in Lishui, China (LLW-FO-403) and was registered at the Chinese Clinical Trial Registry (ChiCTR2300069224, 10 March 2023). Written informed consent was obtained from all patients. All methods were carr...
PMC10500846
Methods
EVENTS
The patients in both groups were routinely administered 10 mL/kg/h lactated Ringer’s solution in a readily accessible hand vein upon admission, and the mean arterial pressure (MAP), electrocardiogram, heart rate (HR), pulse oxygen saturation (SpOAdverse events were defined as follows [
PMC10500846
Outcomes
PMC10500846
Primary outcomes
The primary outcomes of this study were the disappearance time of the eyelash reflex and the following hemodynamic indices: MAP, HR, CO, CI, and SVR.
PMC10500846
Secondary outcome
bradycardia, nausea, vomiting, pain, hypotension
ADVERSE EVENTS, EVENTS, SECONDARY
The secondary outcome of this study was the incidence of adverse events, including hypotension, bradycardia, hiccupping, nausea, injection pain, and vomiting. The patients were monitored for these events from the beginning of anesthetic induction to the completion of endotracheal intubation.
PMC10500846
Statistical analysis
hypotension
The sample size was estimated using PASS 11 software (NCSS, LLC, Kaysville, UT, USA). In our pilot study, the incidence of hypotension elicited by 1.5 mg/kg of propofol was 40% (8/20), which was reduced to 10% (2/20) after pretreatment with 0.2 mg/kg of remimazolam. To achieve 80% (β = 0.20) statistical power with α = ...
PMC10500846
Results
PMC10500846
Demographic characteristics
This trial was conducted from August 2021 to March 2022. Sixty eligible patients were screened and included in the final analyses. The patients’ demographic characteristics, including sex, age, and body mass index, were similar between the two groups (P > 0.05) (Table  Demographic dataValues are expressed as mean ± sta...
PMC10500846
Discussion
hypertension, postoperative nausea and vomiting, P.
ADVERSE EVENTS, CEREBROVASCULAR ACCIDENTS, DISEASE, HYPERTENSION, DISEASES
In this study, we demonstrated that the MAP, HR, CO, and CI at T1, T2, T3, and T4 were significantly higher in Group R than P, while SVR was significantly lower in Group R than P. The incidence of total adverse events was 73% in patients in Group P but only 20% in patients in Group R.Elderly patients’ health is often c...
PMC10500846
Acknowledgements
We thank Angela Morben, DVM, ELS, from Liwen Bianji (Edanz) (
PMC10500846
Authors’ contributions
All authors made substantial contributions to the design of this study, data acquisition and interpretation, statistical planning, drafting of the manuscript, or critical revision of the manuscript. All authors agree to be accountable for all aspects of the work and have approved the final version of the manuscript for...
PMC10500846
Funding
This study was supported by the Project of Zhejiang Medical Association (YS2021-1-15). The funding body had no role in the design of the study; the collection, analysis, or interpretation of the data; or the writing of the manuscript.
PMC10500846
Data Availability
The original contributions presented in this study are included in the article. Further inquiries can be directed to the corresponding authors.
PMC10500846
Declarations
PMC10500846
Ethics approval and consent to participate
This study was approved by the Medical Ethics Committee of The Sixth Affiliated Hospital of Wenzhou Medica University in Lishui, China (LLW-FO-403) and was registered at the Chinese Clinical Trial Registry (ChiCTR2300069224, 10 March 2023). It adheres to the principles outlined in the Declaration of Helsinki and the CO...
PMC10500846
Consent for publication
Not applicable.
PMC10500846
Competing interests
The authors declare that they have no competing interests.
PMC10500846
References
PMC10500846
Subject terms
cough, cord injury, tetraplegia, C-SCI
TETRAPLEGIA
This prospective pilot study investigated the influence of body position on peak cough flow (PCF) during mechanical insufflation–exsufflation (MI-E) treatment in people with tetraplegia. Fifteen participants with cervical spinal cord injury (C-SCI) were randomized into two groups, which differed in the starting positio...
PMC10545699
Introduction
pneumonia, Tetraplegic, cord injury, atelectasis, abdominal muscle weakness, C-SCI, cough
RESPIRATORY FAILURE, PNEUMONIA, ATELECTASIS, NEUROMUSCULAR DISEASES
Respiratory and abdominal muscle weakness due to cervical spinal cord injury (C-SCI) results in a high mortality burden due to respiratory failure, including atelectasis, pneumonia, and ventilator failureAs one such airway clearance technique, mechanical insufflation–exsufflation (MI-E) is a noninvasive cough aid that ...
PMC10545699
Results
PMC10545699
Factors associated with PCF
cough, PCF
The PCF during voluntary cough significantly differed between the positions with a mean PCF of 1.56 ± 0.51 L/s at supine and 1.36 ± 0.62 L/s at reclined positions, respectively (The linear mixed-model (LMM) analysis demonstrated no main effect of assigned group (There was a significant main effect of TIV (Linear mixed-...
PMC10545699
Correlation between TIV and PCF
cough, cough flow(PCF
Because TIV was significantly associated with the generated PCF during MI-E, the correlation between TIV and PCF was analyzed in terms of the applied position. TIV during voluntary cough showed a difference according to the position (Pearson correlation analysis with confidence intervals between the total insufflation ...
PMC10545699
Discussion
cough, myopathy, PCF increase, C-SCI
MYOPATHY
Overall, this study revealed that there was no difference in PCF between the supine and reclined positions when MI-E was applied to patients with C-SCI. However, the generated PCF was affected by the application maneuver and MI-E with additional manual thrust resulted in the most substantial increase, approximately 2.1...
PMC10545699
Methods
PMC10545699
Study Participants
cough, impaired cough, C-SCI
This prospective, randomized crossover pilot study recruited C-SCI patients with impaired cough who required further cough augmentation, defined by a PCF < 270 L/min
PMC10545699
Study design
cough, coughs, fatigue
Eligible participants were randomized in a 1:1 ratio into groups I or II without stratification using a computer-generated block size of 4. Group I started in the supine position, was later reclined to 40° on the first day, and then the reclined position first followed by the supine position on the next day. Conversely...
PMC10545699
MI-E application
cough
MI-E treatment sessions were administered using the CoughAssist E70 (Phillips Respironics, Murrysville, Pennsylvania), which was set to generate 3 s of insufflation, 2 s of exsufflation, and 2 s of rest for one cough, with a low inhale flow setting and oscillation off to simulate physiological coughing and facilitate b...
PMC10545699
Expiratory flow measurement
cough, Expiratory airflow
The in-expiratory airflow generated in both directions during the MI-E session was measured using a flowmeter (CITREX H4 gas flow analyzer, IMT Analytics, Buchs, Switzerland) serially connected to one side of a single-use antibacterial filter towards the facemask interface, and the other side to the CoughAssist E70. Th...
PMC10545699
Statistical analysis
The LMM was used to estimate mean PCF, standard error, and confidence interval which described the changes in the PCF according to the position or maneuver. Applied position, maneuvers, TIV, and interaction between maneuver and position were included as fixed effects, and participant-specific random intercepts were inc...
PMC10545699
Acknowledgements
The authors appreciate a skillful therapist who conducted all pulmonary rehabilitation using MI-E in this study and the Medical Research Collaborating Center for statistical advice.
PMC10545699
Author contributions
S.E.H.: Project conception and organization, Project execution, Interpretation of data, Manuscript writing; H.I.S.: Project conception and organization, Interpretation of data, Manuscript writing, review, and critique; W.J.H. & H.M.J.: Project execution, interpretation of data, manuscript review.
PMC10545699
Funding
This study was supported by the Rehabilitation Research & Development Support Program (#NRCRSP-EX20007) of the National Rehabilitation Center, Ministry of Health and Welfare, Korea.
PMC10545699
Data availability
The data generated and/or analyzed during the current study are available from the corresponding author upon reasonable request.
PMC10545699
Competing interests
The authors declare no competing interests.
PMC10545699
References
PMC10545699
Background
People who smoke and who face challenges trying to quit or wish to continue to smoke may benefit by switching from traditional cigarettes to noncombustible nicotine delivery alternatives, such as heated tobacco products (HTPs) and electronic cigarettes (ECs). HTPs and ECs are being increasingly used to quit smoking, bu...
PMC10131829
Objective
We conducted the first randomized controlled trial comparing quit rates between HTPs and ECs among people who smoke and do not intend to quit.
PMC10131829
Methods
SECONDARY
We conducted a 12-week randomized noninferiority switching trial to compare effectiveness, tolerability, and product satisfaction between HTPs (IQOS 2.4 Plus) and refillable ECs (JustFog Q16) among people who do not intend to quit. The cessation intervention included motivational counseling. The primary endpoint of the...
PMC10131829
Results
A total of 211 participants completed the study. High quit rates (CAR weeks 4-12) of 39.1% (43/110) and 30.8% (33/107) were observed for IQOS-HTP and JustFog-EC, respectively. The between-group difference for the CAR weeks 4-12 was not significant (
PMC10131829
Conclusions
Switching to HTPs elicited a marked reduction in cigarette consumption among people who smoke and do not intend to quit, which was comparable to refillable ECs. User experience and risk perception were similar between the HTPs and ECs under investigation. HTPs may be a useful addition to the arsenal of reduced-risk alt...
PMC10131829
Trial Registration
ClinicalTrials.gov NCT03569748; https://clinicaltrials.gov/ct2/show/NCT03569748
PMC10131829
Introduction
premature deaths
HEAT
According to the World Health Organization, smoking is endemic, with more than 1.1 billion smokers worldwide, resulting in approximately 7 million premature deaths every year [Achieving cessation is challenging, because quit rates are low, relapse rates are high, and many smokers wish to continue to smoke [Substitution...
PMC10131829
Methods
PMC10131829
Study Participants
Eligibility criteria have been described previously in detail [
PMC10131829
Trial Design and Study Visits
Details of the study design and protocol have been previously published [The study was conducted in accordance with the Guideline for Good Clinical Practice and followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines for randomized studies (CONSORT (Consolidated Standards of Reporting Tri...
PMC10131829
Study Products
HTPs and ECs were provided for the whole duration of the intervention phase (12 weeks).
PMC10131829
HTPs
Participants randomized to the HTP arm of the study received IQOS 2.4 Plus consisting of a pen-like holder into which a tobacco stick is inserted and heated, and a battery case to recharge the holder after each use. IQOS 2.4 Plus was the only HTP available on the Italian market when this trial was designed. The device ...
PMC10131829
ECs
Participants randomized to the EC arm of the study received JustFog Q16 Starter Kit consisting of a battery and a 1.9-mL refillable tank fitted with a 1.6-Ohm nichrome coil. Participants could choose from 3 varieties of e-liquid flavors (Puff Riserva Country 16 mg, sweet tobacco flavor; Puff Riserva Toscana 16 mg, full...
PMC10131829
Study Endpoints
SECONDARY
The primary efficacy endpoint of the study was the continuous abstinence rate (CAR) from week 4 to week 12 (CAR weeks 4-12). Abstinence from smoking was defined as eCO-verified (<10 ppm) self-reported abstinence from cigarette smoking. CAR weeks 4-12 was used to compare quit rates between IQOS-HTP and JustFog-EC.The se...
PMC10131829
Study Assessments
The assessments carried out during study visits are listed in Other measurements included the following questionnaires: (1) Fagerstrom Test for Cigarette Dependence [Secondary analyses of blood pressure, heart rate, BMI, and Chester step test results by smoking phenotype classification will be reported in separate pape...
PMC10131829
Ethical Considerations
The Ethical Review Board of Azienda Ospedaliero Universitaria “Policlinico-V. Emanuele,” Università di Catania, Italy, reviewed and approved the study (approval reference number: 215/2017/PO). All participants provided written informed consent prior to participation in the study. The study has been registered at Clinic...
PMC10131829
Statistical Methods
REGRESSION, EVENTS
A detailed description of the sample size calculation can be found in the published research protocol [All the analyses were performed using SAS Version 9.4 (SAS Institute Inc). The primary efficacy endpoint of the study in the experimental study group was calculated with a noninferiority threshold of 15%. An α level o...
PMC10131829
Results
PMC10131829
Smoking Abstinence and Reduction Rates
smoking reduction
Smoking abstinence rates (CAR weeks 4-12), reduction rates (CRR weeks 4-12), and 7-day point prevalence of smoking abstinence and reduction are shown in Smoking abstinence rates and smoking reduction rates. CAR: continuous abstinence rate; CRR: continuous reduction rate; EC: electronic cigarette; HTP: heated tobacco pr...
PMC10131829
Product Preference, Acceptability, and Risk Perception
Among participants in the EC study arm, 50.9% (56/110) chose Puff Riserva Country, 30.9% (34/110) chose Puff Riserva Tuscan, and 18.2% (20/110) chose Puff Artic e-liquid. Among participants in the HTP study arm, 56.4% (62/110) chose Appeal of the study products was analyzed using the mCEQ and mSCAS. No significant with...
PMC10131829
Evaluation of Participant Well-being
EQ-5D-5L and EQ VAS results are summarized in Changes in exercise tolerance between study products were not significant (Chester step test results. EC: electronic cigarette; HTP: heated tobacco product; NS: not significant.
PMC10131829
Predictors of Smoking Abstinence
craving reduction
REGRESSION
The results of the abovementioned logistic regression model showed the following evidence: males were less likely to achieve CAR weeks 4-12 compared to females (OR 0.457, 95% CI 0.249-0.840), subjects who had a high consumption of the product were likely to achieve CAR weeks 4-12 compared to those who had a low consump...
PMC10131829
Adverse Events
ADVERSE EVENTS
The reported numbers of adverse events are listed in
PMC10131829
Discussion
cough, RE, COPD, Cancer
INFECTIOUS DISEASES, ADVERSE EVENT, ADVERSE EVENTS, ADVERSE EVENT, RECRUITMENT, COPD, DEL, CANCER
HTP use elicited a marked reduction in cigarette consumption, resulting in almost 40% abstinence from smoking by the end of the study. When present, adverse events were mild and transitory. This is the first study to directly compare ECs to HTPs, showing comparable effectiveness and tolerability between the JustFog-EC ...
PMC10131829
Abbreviations
continuous abstinence rateConsolidated Standards of Reporting Trialschronic obstructive pulmonary diseasecontinuous reduction rateelectronic cigaretteexhaled carbon monoxideheated tobacco productmodified Cigarette Evaluation Questionnairemodified Smoking Cue Appeal Surveynicotine delivery alternativeodds ratioPerceived...
PMC10131829
Data Availability
We may share deidentified individual participant-level data that underlie the results reported in this article. Data will be available on receipt of a request detailing the study hypothesis and statistical analysis plan. All requests should be sent to the corresponding author. Based on the scientific rigor of the propo...
PMC10131829
Background
cognitive decline
Finding innovative yet feasible ways of preventing physical and cognitive decline in those at risk is a critical global challenge, with exercise being championed as a key precursor to robust health in later life. Exercise snacking, here defined as short bouts of sporadic [muscle-strengthening] exercise, is one such str...
PMC10403822
Methods
mild-cognitive impairment
In this single group design, 21 pre-frail outpatients with mild-cognitive impairment were recruited from a UK memory clinic. To be eligible, participants were aged ≥ 65-years who scored 3–8 (inclusive) on the short physical performance battery (SPPB) and were not regularly engaging in sport or exercise. Participants co...
PMC10403822
Results
Eighteen participants provided follow-up data and showed 85% adherence to the exercise snacking intervention, measured as the proportion of all sessions completed out of a possible 56. Participants rated the intervention as highly acceptable (4.6/5) suggesting it supported their self-efficacy (4.3/5) was enjoyable (4.1...
PMC10403822
Conclusions
Exercise snacking is an acceptable and potentially efficacious format of exercise for pre-frail memory clinic attendees who are at heightened risk of falling and frailty. Large scale randomised controlled trials are required to confirm whether exercise snacking is effective in the short and long term.
PMC10403822
ClinicalTrials.gov registration
NCT05439252 (30/06/2022)
PMC10403822
Supplementary Information
The online version contains supplementary material available at 10.1186/s12877-023-04169-6.
PMC10403822
Keywords
PMC10403822
Background
cognitive decline, dementia, cognitive impairment
The prevalence of age associated physical and cognitive decline is markedly rising due to the ageing population and places an enormous strain on health and social care in the UK [Older people with cognitive impairment are markedly more likely to have reduced physical function and strength, and ultimately a greater fall...
PMC10403822
Methods
PMC10403822
Study design
This pilot study used a single group, pre-test-post-test design to assess the acceptability homebased ‘exercise snacking’ in older adult patients attending the memory clinic at the Research Institute for the Care of Older People (RICE) in Bath, UK. All participants were asked to undertake 28 days of twice daily exercis...
PMC10403822
Participants
cognitive impairment
RECRUITMENT
Outpatients attending the memory clinic at RICE who were identified as being potentially eligible to participate in the present pilot study were invited to participate by RICE gerontology clinicians. Interested individuals were referred to study staff, with clinicians taking no further roll in study procedures. Eligibi...
PMC10403822
Assessments
RPE
Intervention acceptability was assessed by a theoretical framework of acceptability questionnaire on participant experiences of exercise snacking completed at the follow-up assessment only. The seven domains (Affective attitude; Burden; Ethicality; Intervention Coherence; Opportunity Cost; Perceived effectiveness; and ...
PMC10403822
Intervention
ADVERSE EVENTS, MINOR, EVENT
The exercise snacking intervention consisted of five exercises, each performed for one minute interspersed with one minute of seated rest, with the aim being to complete as many repetitions as possible of each exercise in the given minute. The total length of each exercise ‘snack’ was therefore nine minutes. Participan...
PMC10403822
Statistical analysis
The primary outcome of acceptability of the exercise snacking intervention was assessed descriptively based on the scores from the TFA questionnaire, and qualitatively using framework analysis [
PMC10403822