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PRECISION study: impact of personalised cardiac anaesthesia and cerebral autoregulation on neurological outcomes in patients undergoing cardiac surgery - protocol for an international, multicentre, prospective cohort study

Por: Gomes · N. V. · Edgar-Whelan · H. · Beqiri · E. · Young · J. · Schindler · C. · Gregor · M. · Erb · J. M. · Siegemund · M. · Kuhle · J. · Maleska Maceski · A. · Needham · E. · Cichon · S. · Burger · B. · Monsch · A. U. · Hasemann · W. · Wüest · A. · Fassl · J. · Kaiser · H. A. · Hight · D
Introduction

Adverse neurological complications, including postoperative delirium (POD) and stroke, remain one of the major risks after cardiac surgery. A lack of comprehensive knowledge about their causes and neuroprotective strategies has hindered the development of effective interventions to reduce these events. Personalised cerebral autoregulation (CA)-oriented blood pressure monitoring aims to identify blood pressure targets tailored to each individual patient, thereby reducing brain injury. The PRECISION study aims to assess whether perioperative duration and magnitude of mean arterial pressure (MAP) deviation from an individual’s CA limits are associated with adverse neurological complications.

Methods and analysis

This international, multicentre, prospective cohort study is conducted at two Swiss and one British hospital. Patients aged 65 years or older undergoing elective primary or re-operative coronary artery bypass graft and/or valvular and/or ascending aorta surgery requiring cardiopulmonary bypass are included. Preoperatively, the patient’s baseline of physical, cognitive and mental status is established. Intraoperatively, near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD) are recorded in real-time to generate NIRS-derived and TCD-derived CA indices. The primary endpoint is POD, assessed daily on postoperative days 0 to 7 or up to discharge, whichever occurs earlier with the 3D-Confusion Assessment Method (3D-CAM) or CAM-Intensive Care Unit. Secondary endpoints include a composite neurological outcome of POD and overt stroke, postoperative neurocognitive disorders, major morbidity and mortality. Associations between neurologic outcomes, neurobiomarkers and genetic variation will be explored.

A total of 500 participants is required to achieve 90% power to find a statistically significant effect of the area under the curve MAP

Ethics and dissemination

Ethical approval has been obtained from all responsible ethics committees (Swiss lead ethics committee EKNZ 2022-01457 and Health Research Authority and Health and Care Research Wales, UK, REC 23/SW/0076). Results will be disseminated at national and international conferences and published in peer-reviewed journals.

Trial registration number

NCT05595954.

The PROTECT trial: Effect of titrated versus conventional induction of general anaesthesia using a target-controlled infusion system on haemodynamics in patients undergoing non-cardiac surgery - protocol for a multicentre, expertise-based randomised contr

Por: Funk · S. · Lohri · M. D. · Kopp Lugli · A. · Schindler · C. · Wiencierz · A. · Mnich · K. · Schläpfer · M. · Gaberdiel · A. P. · Puhan · M. A. · Steiner · L. A. · Gomes · N. V. · Dell-Kuster · S.
Introduction

Hypotension is a frequent complication after induction of general anaesthesia leading to end-organ injury, for which elderly and multimorbid patients are particularly susceptible. The extent of hypotension depends, among other factors, on the dose and rate of propofol administration. Target-controlled infusion systems are widely used to administer short-acting anaesthetics such as propofol and remifentanil. Commonly, induction is started with a fixed effect-site concentration. Titration, an alternative method of induction using an incremental augmentation of propofol, leads to a reduced induction dose and rate of propofol. We hypothesise that the titration method improves haemodynamic stability compared with conventional induction.

Methods and analysis

This multicentre, expertise-based randomised controlled trial takes place at four Swiss hospitals. Patients ≥55 years of age undergoing non-cardiac surgery under general anaesthesia using propofol target-controlled infusion are randomised to either a conventional or a titrated anaesthesia induction method. Patients, statisticians and, if resources allow, outcome assessors will be blinded. The primary endpoint is the mean arterial pressure under the individual baseline mean arterial pressure (area under threshold) during the first 30 min after start of induction. Secondary endpoints include the maximum deviation from baseline mean arterial pressure, haemodynamic rescue methods, propofol consumption and neurocognitive recovery after regaining consciousness.

A total of 320 patients are required to have an 80% chance of observing superiority of titration for the area under the threshold as significant at the 5% level, assuming a true difference of 100 mm Hg*min. The area under threshold and the maximum deviation will be compared between arms using mixed linear regression models.

Ethics and dissemination

Ethical approval has been obtained from all responsible ethics committees (BASEC2025-01007). The results will be presented at international meetings and published in peer-reviewed journals and may contribute to a change in clinical practice for anaesthesia induction using target-controlled infusion systems with propofol.

Trial registration number

clinicaltrials.gov (NCT06980688) and www.humanforschung-schweiz.ch (HumRes67022).

Feasibility of implementing a non-invasive self-sampling method for saliva specimens that can be used for the diagnosis of respiratory infections among paediatric patients in the Tshwane District, South Africa: a study protocol

Por: Nxele · S. · Dlangalala · T. · Gxekwa · N. V. · Ramatsokotla · S. · Musekiwa · A. · Kgatle · M. M. · Hatchett · D. B. · Shin · A. · Tu · W.-c. · Robertson · I. H. · Su · X. · Berthier · E. · Thongpang · S. · Theberge · A. B. · Mashamba-Thompson · T. P.
Introduction

Effective community-based disease management is essential for public health. In low- and middle-income countries, sustainable strategies for timely diagnosis and treatment are a research priority. This study aims to assess the feasibility of a non-invasive saliva self-sampling method, paired with digitally linked molecular point-of-care diagnostics, for detecting respiratory infections among paediatric patients in the Tshwane District, South Africa.

Methods and analysis

A field study will be conducted at Steve Biko Academic Hospital to compare saliva collection using the CandyCollect lollipop device and standard mouth swabs. The spiral groove of the lollipop device captures pathogens, which are stored in DNA/RNA preservation media and later analysed using quantitative PCR and commercially available rapid antigen tests. The multiplex respiratory pathogen panel, based on TaqMan real-time PCR technology, targets key paediatric pathogens including Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, respiratory syncytial virus (RSV) and influenza A/B. Nucleic acids will be extracted using standard viral extraction kits and analysed following manufacturer protocols. Internal controls will be included in each qPCR run, and samples with CT values below defined thresholds will be considered positive. Rapid antigen tests will detect common pathogens such as influenza A/B, RSV and SARS-CoV-2 for comparative analysis. User experience and acceptability will be assessed via child-friendly and caregiver surveys following sample collection. The study will be implemented in two phases: diagnostic performance evaluation and user feedback assessment. The protocol is aligned with the Standard Protocol Items: Recommendations for Interventional Trials 2013 checklist.

Ethics and dissemination

Ethical approval has been granted by the University of Pretoria (509/2023) and the Gauteng Department of Health (GP_202406_032). The study is registered in the Pan African Clinical Trial Registry (PACTR202411743094783). Findings will be disseminated through peer-reviewed journals, conferences and stakeholder briefings. The study complies with South Africa’s Protection of Personal Information Act. Data collection is scheduled from November 2024 to February 2025, with project completion expected within 1 year.

Trial registration number

Pan African Clinical Trial Registry (PACTR202411743094783).

Bridging the gap in full immunisation coverage with parental awareness and attitudes: a community-based cross-sectional analysis on routine childhood vaccinations in Perambalur district of Tamil Nadu, South India

Por: Mohandas · N. V. · Mohandas · V. · Dinesh · A. · Vijayakumar · K. · Anand · V. · Karve · S. S.
Objectives

To determine the independent predictors of full immunisation coverage (FIC) among children aged 12–23 months along with the parental awareness and attitudes (of children aged ≤23 months) regarding routine childhood vaccinations in Perambalur district of Tamil Nadu, South India.

Design

A community-based cross-sectional analysis.

Setting

Perambalur district situated in the central region of Tamil Nadu state, South India.

Participants

Parents of children aged ≤23 months.

Outcome measures

The primary outcome measured was the FIC and FIC plus in the district along with the parental awareness and attitudes regarding routine childhood vaccinations. The independent predictors of FIC and FIC plus were determined using multivariable logistic regression models.

Results

The study included 652 children, with a mean (±SD) age of 16.47 (±6.37) months and a male-to-female ratio of 60:40. The FIC and FIC plus of children aged 12–23 months were 91.3% (95% CI 88.64 to 93.33) and 79.7% (95% CI 76.15 to 82.80), respectively. The immunisation card retention was 97.9% among the parents of children aged 12–23 months. The independent predictors of FIC included below poverty line families (adjusted OR (AOR) 0.11; 95% CI 0.02 to 0.64), illiteracy among mothers (AOR 0.67; 95% CI 0.32 to 0.87), lack of immunisation card (AOR 0.14; 95% CI 0.03 to 0.55), lack of frequent home visits by healthcare worker (AOR 0.38; 95% CI 0.18 to 0.79) and hesitancy of parents towards vaccination (AOR 0.26; 95% CI 0.12 to 0.87).

Conclusion

This study revealed a high FIC in this specific district. However, achieving full coverage is influenced by factors like socioeconomic status, maternal education and parental attitudes. Understanding these factors is essential for improving immunisation rates and ensuring all children are protected.

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