scholarly journals Repeat assessment of examination signs among children in Malawi with fast-breathing pneumonia

2020 ◽  
Vol 6 (2) ◽  
pp. 00275-2019
Author(s):  
Jennifer L. Lenahan ◽  
Evangelyn Nkwopara ◽  
Melda Phiri ◽  
Tisungane Mvalo ◽  
Mari T. Couasnon ◽  
...  
Keyword(s):  
Placebo Group ◽  
Randomised Controlled Trial ◽  
Physical Examination ◽  
Controlled Trial ◽  
Arterial Oxygen Saturation ◽  
Vital Signs ◽  
Arterial Oxygen ◽  
Support Providers ◽  
Randomised Controlled ◽  
Repeat Assessment

BackgroundAs part of a randomised controlled trial of treatment with placebo versus 3 days of amoxicillin for nonsevere fast-breathing pneumonia among Malawian children aged 2–59 months, a subset of children was hospitalised for observation. We sought to characterise the progression of fast-breathing pneumonia among children undergoing repeat assessments to better understand which children do and do not deteriorate.MethodsVital signs and physical examination findings, including respiratory rate, arterial oxygen saturation measured by pulse oximetry (SpO2), chest indrawing and temperature were assessed every 3 h for the duration of hospitalisation. Children were assessed for treatment failure during study visits on days 1, 2, 3 and 4.ResultsHospital monitoring data from 436 children were included. While no children had SpO2 90–93% at baseline, 7.4% (16 of 215) of children receiving amoxicillin and 9.5% (21 of 221) receiving placebo developed SpO2 90–93% during monitoring. Similarly, no children had chest indrawing at enrolment, but 6.6% (14 of 215) in the amoxicillin group and 7.2% (16 of 221) in the placebo group went on to develop chest indrawing during hospitalisation.ConclusionRepeat monitoring of children with fast-breathing pneumonia identified vital and physical examination signs not present at baseline, including SpO2 90–93% and chest indrawing. This information may support providers and policymakers in developing guidance for care of children with nonsevere pneumonia.

scholarly journals YinQiSanHuang Jiedu decoction for the treatment of hepatitis B-related compensated liver cirrhosis: study protocol for a multicentre randomised controlled trial.

2021 ◽  
Author(s):  
Qing-Juan Wu ◽  
Wen-Liang Lv ◽  
Juan-Mei Li ◽  
Ting-Ting Zhang ◽  
Wen-Hui Zhou ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Liver Cirrhosis ◽  
Placebo Group ◽  
Chinese Medicine ◽  
Randomised Controlled Trial ◽  
Traditional Chinese Medicine ◽  
Liver Fibrosis ◽  
Hepatitis B ◽  
Controlled Trial ◽  
Randomised Controlled

Abstract Introduction: Hepatitis B-related compensated liver cirrhosis is related to higher risk of hepatocellular carcinoma, anti-viral therapy is the preferred method. As the pathological mechanisms of liver fibrosis are complex, drugs developed for a single target are difficult to be effective in clinical practice, so there are no chemical drugs or biological drugs with clear efficacy available for clinical application at present. Traditional Chinese medicine is a kind of medical science that has been gradually formed during thousands of years and continuously enriched by the people of all ethnic groups in China. Traditional chinese medicine shows curative effects in the treatment of liver diseases, especially in the field of liver fibrosis prevention and treatment. This study aim to test the integrative medicine (chinese medicine plus anti-riral therapy) effective on lowing hepatocellular carcinoma risk among patients with hepatitis B-related compensated liver cirrhosis.Methods and Analysis: This is a multicentre randomised controlled trial, total 5 hospitals and 802 patients will involved in. All the subjects are randomly allocated to the YinQiSanHuang Jiedu decoction(YQSHD) group (n=401) or the placebo group (n=401). The YQSHD group receives YQSHD granule with Entecavir(ETV), the placebo group receives YQSHD placebo with ETV. Treatment period will last for 52 weeks, and follow-up period for 52±2 weeks. The primary outcome measure is the annual incidence of HCC. Outcomes will be assessed at baseline and after treatment. Objective of this trial is “the integrative of YQSHD with ETV reduce the annual incidence of HCC to 1%”.Ethics and dissemination:The protocol has been approved by the Medical Ethics Committee of Guang’anmen Hospital, China (No.2019-006-KY), and the other centres in the trial will not begin recruiting until local ethical approval has been obtained.Trial final results will be disseminated via publication. Trial registration: ChiCTR1900021532, this protocol was registered in the Chinese Clinical Trial Registry (URL: http://www.chictr.org.cn/searchproj.aspx) on February 26th, 2019.

Olanzapine or chlorpromazine plus lithium in first episode psychotic mania: An 8-week randomised controlled trial

2015 ◽  
Vol 30 (8) ◽  
pp. 975-982 ◽  
Author(s):  
P. Conus ◽  
M. Berk ◽  
S.M. Cotton ◽  
L. Kader ◽  
C. Macneil ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Safety Profile ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Vital Signs ◽  
Treatment Strategies ◽  
First Episode ◽  
Safety And Efficacy ◽  
Randomised Controlled ◽  
Over Time

AbstractBackgroundTreatment strategies for mental disorders may vary according to illness stage. However no data currently exist to guide treatment in first episode psychotic mania. The aim of this study was to compare the safety and efficacy profile of chlorpromazine and olanzapine, as add-on to lithium, in patients with a first episode of psychotic mania, expecting better safety profile and adherence to olanzapine but similar efficacy for both treatments.MethodsData from 83 patients were collected in an 8-week randomised controlled trial on clinical variables, side effects, vital signs, and weight. Analyses of treatment differences over time were based on intent-to-treat principles. Kaplan-Meier estimated survival curves were used to analyse time-to-event data and mixed effects models repeated measures analysis of variance were used to determine treatment group differences over time on safety and efficacy measures.ResultsEthics committee approval to delay informed consent procedure until recovery from the acute episode allowed the inclusion of 83 patients highly representative of those treated in the public sector. Contrary to our hypotheses, safety profile of both medications was similar. A signal for higher rate (P=.032) and earlier occurrence (P= .043) of mania remission was observed in the olanzapine group which did not survive correction for multiple comparisons.ConclusionsOlanzapine and chlorpromazine have a similar safety profile in a uniquely representative cohort of patients with first episode psychotic mania. The possibility for a greater impact of olanzapine on manic symptoms leading to earlier remission of the episode needs exploration in a large sample.

scholarly journals Investigating the impact of patient-centred labels on comprehension of medication dosing: a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e053969
Author(s):  
Ahsan Saleem ◽  
Gemma Woodruff ◽  
Kathryn Steadman ◽  
Adam La Caze
Keyword(s):  
Health Literacy ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Vital Signs ◽  
Pharmacy Practice ◽  
Care Hospital ◽  
Randomised Controlled ◽  
The Impact ◽  
High Health Literacy

ObjectiveThis study aims to implement a version of patient-centred labels (PCL) consistent with current labelling practice in Australia; assess the effectiveness of PCL in relation to the proportion of participants that correctly comprehend dosing instructions, and explore the proportion of correct comprehension of PCL in participants with both low and high health literacy.DesignRandomised controlled trial.SettingA large tertiary care hospital in Brisbane, Queensland, Australia.Participants121 participants with a majority born in Australia (65.3%), New Zealand (14.0%), the UK (6.6%) and Ireland (2.5%).InterventionParticipants were randomly assigned to either a panel of three PCL (n=61) or three standard labels (n=60) and asked to comprehend their assigned panel of labels.Outcome measuresDifference in the proportion of participants that correctly comprehend dosing instructions provided on PCL compared with standard labels. The two-proportion test was used to measure the impact of PCL on the proportion of participants correctly comprehending dosing instructions.ResultsA greater proportion of participants were able to accurately comprehend PCL compared with standard labels. The proportion of participants who were able to correctly comprehend dose instructions provided on all three labels was significantly higher in the group that received PCL; 23.3% standard vs 83.6% PCL, p<0.001. The effect was observed in both low and high health literacy participants. The proportion of participants with accurate label comprehension was higher in participants with low Newest Vital Signs scores (8.3% standard vs 85.7% PCL, p<0.001) and low Rapid Estimate of Adult Literacy in Medicine scores (10.5% standard vs 96.0% PCL, p<0.001) who received PCL.ConclusionThis study supports the use of PCL in Australian pharmacy practice. PCL provide simple, clear and explicit dosing instructions to patients. Implementing PCL may reduce the risk of misinterpreting dosing instructions by patients and improve quality use of medicines.Trial registration numberACTRN12621000083897; Results.

scholarly journals Sulodexide in the treatment of patients with early stages of COVID-19: a randomised controlled trial

2020 ◽  
Author(s):  
Alejandro J. Gonzalez-Ochoa ◽  
Joseph D. Raffetto ◽  
Ana G. Hernández ◽  
Nestor Zavala ◽  
Obed Gutiérrez ◽  
...  
Keyword(s):  
Placebo Group ◽  
Randomised Controlled Trial ◽  
Hospital Admissions ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Well Being ◽  
Outpatient Setting ◽  
Effective Vaccine ◽  
Parallel Group Design ◽  
Randomised Controlled

AbstractBackgroundTargeting endothelial cells has been suggested for the treatment of patients with COVID-19 and sulodexide has pleiotropic properties within the vascular endothelium that can prove beneficial to the same. We aimed to evaluate the effect of sulodexide when used in the early clinical stages of COVID-19.MethodsWe conducted a single-centre, outpatient setting, randomised controlled trial with a parallel-group design in Mexico. Including patients within three days of clinical symptom onset, who were at a high risk of severe clinical progression due to chronic comorbidities. Participants were randomly allocated to receive an oral dose of sulodexide (500 LRU twice a day) or the placebo for 21 days. Primary outcomes were need and length of hospitalisation, need and length of oxygen support.ResultsBetween June 5 and August 30, 2020, 243 patients were included in the “per-protocol” analysis. One hundred twenty-four of them received sulodexide, while 119 received placeboes. At 21 days follow-up, 22 of 124 patients required hospitalisation in the sulodexide group compared to 35 of 119 in the placebo group [relative risk (RR), 0·6; 95% confidence interval (CI), 0·37-0·96; p=0·03]. Fewer patients required oxygen support in the sulodexide group [37 of 124 vs. 50 of 119; RR, 0·71; 95% CI, 0·5 to 1; p=0·05], and for fewer days (9±7·2 in the sulodexide group vs. 11·5±9·6 in the placebo group; p=0·02). There was no between-group difference concerning the length of hospital stay.InterpretationEarly intervention in COVID-19 patients with sulodexide reduced hospital admissions and oxygen support requirements, although with no significant effect on mortality. This has beneficial implications in the patient well-being, making sulodexide a favourable medication until an effective vaccine or an antiviral becomes available.FundingResearcher independently initiated, partially funded by Alfasigma, Mexico.Listed in the ISRCTN registry under ID ISRCTN59048638.

scholarly journals Systemic Oxygen Delivery during One-Lung Ventilation: Comparison between Propofol and Sevoflurane Anaesthesia in a Randomised Controlled Trial

2019 ◽  
Vol 8 (9) ◽  
pp. 1438
Author(s):  
Tae Soo Hahm ◽  
Heejoon Jeong ◽  
Hyun Joo Ahn
Keyword(s):  
Randomised Controlled Trial ◽  
Oxygen Delivery ◽  
Controlled Trial ◽  
Lung Ventilation ◽  
Arterial Oxygen ◽  
One Lung Ventilation ◽  
Systemic Oxygen Delivery ◽  
Patient Status ◽  
Systemic Oxygen ◽  
Randomised Controlled

Systemic oxygen delivery (DO2) is a more comprehensive marker of patient status than arterial oxygen saturation (SaO2), and DO2 in the range of 330–500 mL min−1 is reportedly adequate during anaesthesia. We measured DO2 during one-lung ventilation (OLV) for thoracic surgery—where the risk of pulmonary shunt is significant, and hypoxia occurs frequently—and compared sevoflurane and propofol, the two most commonly used anaesthetics in terms of DO2. Sevoflurane impairs hypoxic pulmonary vasoconstriction. Thus, our hypothesis was that propofol-based anaesthesia would show a higher DO2 value than sevoflurane-based anaesthesia. This was a double-blinded randomised controlled trial conducted at a university hospital from 2017 to 2018. The study population consisted of patients scheduled for lobectomy under OLV (N = 120). Sevoflurane or propofol was titrated to a bispectral index of 40–50. Haemodynamic variables were measured during two-lung ventilation (TLV) and OLV at 15 and 45 min (OLV15 and OLV45, respectively) using oesophageal Doppler monitoring. The mean DO2 (mL min−1) was not different between the sevoflurane and propofol anaesthesia groups (TLV: 680 vs. 706; OLV15: 685 vs. 703; OLV45: 759 vs. 782, respectively). SaO2 was not correlated with DO2 (r = 0.09, p = 0.100). Patients with SaO2 < 94% showed adequate DO2 (641 ± 203 mL min−1), and patients with high SaO2 (> 97%) showed inadequate DO2 (14% of measurements < 500 mL min−1). In conclusion, DO2 did not significantly differ between sevoflurane and propofol. SaO2 was not correlated with DO2 and was not informative regarding whether the patients were receiving an adequate oxygen supply. DO2 may provide additional information on patient status, which may be especially important when patients show a low SaO2.

scholarly journals Nocturnal cerebral hypoxia in obstructive sleep apnoea: a randomised controlled trial

2018 ◽  
Vol 51 (5) ◽  
pp. 1800032 ◽  
Author(s):  
Esther I. Schwarz ◽  
Michael Furian ◽  
Christian Schlatzer ◽  
John R. Stradling ◽  
Malcolm Kohler ◽  
...  
Keyword(s):  
Obstructive Sleep Apnoea ◽  
Near Infrared ◽  
Controlled Trial ◽  
Arterial Oxygen Saturation ◽  
Sleep Apnoea ◽  
Arterial Oxygen ◽  
Cerebral Hypoxia ◽  
Cerebral Damage ◽  
Obstructive Sleep ◽  
Randomised Controlled

Cerebral hypoxia may promote cerebral damage in patients with obstructive sleep apnoea (OSA). We investigated whether OSA patients experience nocturnal cerebral hypoxia that is prevented by continuous positive airway pressure (CPAP).OSA patients using CPAP underwent sleep studies including pulse oximetry (arterial oxygen saturation (SpO2)) and near-infrared spectroscopy to monitor cerebral tissue oxygenation (CTO) at baseline and after 2 weeks on either subtherapeutic or therapeutic CPAP according to randomised allocation. Changes in oxygenation at end of the 2-week intervention were compared between groups.Among 21 patients (mean apnoea/hypopnoea index 50.3 events·h−1), OSA recurred in all nine patients using subtherapeutic CPAP and in none of the patients using therapeutic CPAP: mean (95% CI) between-group differences in changes of oxygen desaturation index from baseline to 2 weeks +40.7 (31.1–50.4) events·h−1 for SpO2 and +37.0 (25.3–48.7) events·h−1 for CTO (both p<0.001). Mean nocturnal SpO2 and CTO decreased more in patients using subtherapeutic versus therapeutic CPAP: −2.4 (−3.4–−1.1)% and −3.8 (−7.4–−0.1)%, respectively; both p<0.03. Severe CTO drops ≥13% associated with cerebral dysfunction in previous studies occurred in four out of nine patients using subtherapeutic CPAP, but in none out of 12 patients using therapeutic CPAP (p=0.01).In patients with OSA, CPAP withdrawal resulted in nocturnal cerebral deoxygenation, suggesting a role of cerebral hypoxia in predisposing untreated OSA patients to cerebral damage.

scholarly journals Trial of remote continuous versus intermittent NEWS monitoring after major surgery (TRaCINg): a feasibility randomised controlled trial

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
C. L. Downey ◽  
J. Croft ◽  
G. Ainsworth ◽  
H. Buckley ◽  
B. Shinkins ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Remote Monitoring ◽  
Controlled Trial ◽  
Intervention Group ◽  
Vital Signs ◽  
Length Of Hospital Stay ◽  
Major Surgery ◽  
Control Group ◽  
Vital Signs Monitoring ◽  
Randomised Controlled

Abstract Background Despite medical advances, major surgery remains high risk with up to 44% of patients experiencing postoperative complications. Early recognition of postoperative complications is crucial in reducing morbidity and preventing long-term disability. The current standard of care is intermittent manual vital signs monitoring, but new wearable remote monitors offer the benefits of continuous vital signs monitoring without limiting the patient’s mobility. The aim of this study was to evaluate the feasibility, acceptability and clinical outcomes of continuous remote monitoring after major surgery. Methods The study was a randomised, controlled, unblinded, parallel group, feasibility trial. Adult patients undergoing elective major surgery were randomly assigned to receive continuous remote monitoring and normal National Early Warning Score (NEWS) monitoring (intervention group) or normal NEWS monitoring alone (control group). Continuous remote monitoring was achieved using the SensiumVitals® wireless patch which is worn on the patient’s chest and monitors heart rate, respiratory rate and temperature continuously, and alerts the nurse when there is deviation from pre-set physiological norms. Feasibility was assessed by evaluating recruitment rate, adherence to protocol and randomisation and the amount of missing data. Clinical outcomes included time to antibiotics in cases of sepsis, length of hospital stay, number of critical care admissions and rate of hospital readmission within 30 days of discharge. Results One hundred and thirty-six patients were randomised between October 2018 and April 2019: 67 to the control group and 69 to the intervention group. Recruitment was completed prior to the 12 month target with a high rate of eligibility and consent. Missing data was limited only to questionnaire responses; no participants were lost to follow-up and only one participant was withdrawn due to loss of capacity. The number of patients classed as ‘drop-out’ due to design (8.1%) were less than anticipated, and there were no participants who crossed over into the alternative trial allocation group. Seventeen participants in the intervention group (28%) did not adhere to the monitoring protocol. No formal comparisons between arms was undertaken; however, participants had fewer unplanned critical care admissions (1 versus 5) and had a shorter average length of hospital stay (11.6 days (95% confidence interval 9.5–13.7 days) versus 16.2 days (95% confidence interval 11.3–21.2 days)) in the continuous vital signs monitoring group. The time taken to receive antibiotics in cases of sepsis was similar in both arms. A cost-utility analysis indicated that the remote monitoring system was cost-saving when compared to standard NEWS monitoring alone. Conclusions It is feasible to perform a large-scale randomised controlled trial of continuous remote monitoring after major surgery. Progression to a definitive multicentre randomised controlled trial would be appropriate, taking consideration of factors, such as patient adherence, that might mask the potential benefit of additional monitoring. Trial registration ISRCTN registry with study ID ISRCTN16601772. Registered 30 August 2017.

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