Dataset Information

Anaesthetic protocol for paediatric glaucoma examinations: the prospective EyeBIS Study protocol.

ABSTRACT:

Introduction

Neonates and young infants with diagnosed or highly suspected glaucoma require an examination under anaesthesia to achieve accurate intraocular pressure (IOP) measurements, since crying or squinting of the eyes may increase IOP and lead to falsely high values. IOP considerably depends on perioperative variables such as haemodynamic factors, anaesthetics, depth of anaesthesia and airway management. The aim of this paper is to report the design and baseline characteristics of EyeBIS, which is a study to develop a standardised anaesthetic protocol for the measurement of IOP under anaesthesia in childhood glaucoma, by investigating the link between the magnitude of IOP and depth of anaesthesia.

Methods and analysis

This is a single-centre, prospective cohort study in 100 children with diagnosed or highly suspected glaucoma all undergoing ophthalmological examination under general anaesthesia. 20 children, who undergo general anaesthesia for other reasons, are included as controls. The primary outcome measure is the establishment of a standardised anaesthetic protocol for IOP measurement in childhood glaucoma by assessing the relationship between IOP and depth of anaesthesia (calculated as an electroencephalography variable, the bispectral index), with special emphasis on airway management and haemodynamic parameters. The dependence of IOP under anaesthesia on airway management and haemodynamic parameters will be described, using a mixed linear model. Restricting the model to patients with healthy eyes will allow to determine a 95% reference region, in which 95% of the measurement values of patients with healthy eyes can be expected.

Ethics and dissemination

The study has been approved by the local ethics committee of the Medical Association of Rhineland-Palatine (Ethik-Kommisssion der Landesaerztekammer Rheinland-Pfalz), Germany (approval number: 2019-14207). This work will be disseminated by publication of peer-reviewed manuscripts, presentation in abstract form at national and international scientific meetings and data sharing with other investigators.

Trial registration number

ClinicalTrials.gov Registry (NCT03972852).

SUBMITTER: Pirlich N

PROVIDER: S-EPMC8493900 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:IntroductionHospitalised paediatric oncology patients are at risk to develop acute complications. Early identification of clinical deterioration enabling adequate escalation of care remains challenging. Various Paediatric Early Warning Systems (PEWSs) have been evaluated, also in paediatric oncology patients but mostly in retrospective or case-control study designs. This study protocol encompasses the first prospective cohort with the aim of evaluating the predictive performance of a modified Bedside PEWS score for non-elective paediatric intensive care unit (PICU) admission or cardiopulmonary resuscitation in hospitalised paediatric oncology patients.Methods and analysisA prospective cohort study will be conducted at the 80-bed Dutch paediatric oncology hospital, where all national paediatric oncology care has been centralised, directly connected to a shared 22-bed PICU. All patients between 1 February 2019 and 1 February 2021 admitted to the inpatient nursing wards, aged 0-18 years, with an International Classification of Diseases for Oncology (ICD-O) diagnosis of paediatric malignancy will be eligible. A Cox proportional hazard regression model will be used to estimate the association between the modified Bedside PEWS and time to non-elective PICU transfer or cardiopulmonary arrest. Predictive performance (discrimination and calibration) will be assessed internally using resampling validation. To account for multiple occurrences of the event of interest within each patient, the unit of study is a single uninterrupted ward admission (a clinical episode).Ethics and disseminationThe study protocol has been approved by the institutional ethical review board of our hospital (MEC protocol number 16-572/C). We adapted our enrolment procedure to General Data Protection Regulation compliance. Results will be disseminated at scientific conferences, regional educational sessions and publication in peer-reviewed journals.Trial registration numberNetherlands Trial Registry (NL8957).

Project description:ObjectiveTo determine patient, institution, and machine characteristics that contribute to variation in radiation doses used for computed tomography (CT).DesignProspective cohort study.SettingData were assembled and analyzed from the University of California San Francisco CT International Dose Registry.ParticipantsStandardized data from over 2.0 million CT examinations of adults who underwent CT between November 2015 and August 2017 from 151 institutions, across seven countries (Switzerland, Netherlands, Germany, United Kingdom, United States, Israel, and Japan).Main outcome measuresMean effective doses and proportions of high dose examinations for abdomen, chest, combined chest and abdomen, and head CT were determined by patient characteristics (sex, age, and size), type of institution (trauma center, care provision 24 hours per day and seven days per week, academic, private), institutional practice volume, machine factors (manufacturer, model), country, and how scanners were used, before and after adjustment for patient characteristics, using hierarchical linear and logistic regression. High dose examinations were defined as CT scans with doses above the 75th percentile defined during a baseline period.ResultsThe mean effective dose and proportion of high dose examinations varied substantially across institutions. The doses varied modestly (10-30%) by type of institution and machine characteristics after adjusting for patient characteristics. By contrast, even after adjusting for patient characteristics, wide variations in radiation doses across countries persisted, with a fourfold range in mean effective dose for abdomen CT examinations (7.0-25.7 mSv) and a 17-fold range in proportion of high dose examinations (4-69%). Similar variation across countries was observed for chest (mean effective dose 1.7-6.4 mSv, proportion of high dose examinations 1-26%) and combined chest and abdomen CT (10.0-37.9 mSv, 2-78%). Doses for head CT varied less (1.4-1.9 mSv, 8-27%). In multivariable models, the dose variation across countries was primarily attributable to institutional decisions regarding technical parameters (that is, how the scanners were used).ConclusionsCT protocols and radiation doses vary greatly across countries and are primarily attributable to local choices regarding technical parameters, rather than patient, institution, or machine characteristics. These findings suggest that the optimization of doses to a consistent standard should be possible.Study registrationClinicaltrials.gov NCT03000751.

Project description:IntroductionLumbar pain of facet origin is a common problem worldwide. For those patients not responding to traditional treatment, one approach may be intra-articular infiltration of corticoid and anaesthetic. However, despite the increasing demand for this procedure, no consensus exists regarding its therapeutic value. The selection of eligible participants may be a determining factor since only those with an inflammatory process will benefit from the use of corticosteroids. This study aims to identify differences in disability, pain and quality of life scores in individuals with and without facet joint inflammation who were diagnosed using MRI.Method and analysisThis prospective cohort will include individuals older than 18 years with a clinical diagnosis of facet syndrome who underwent intra-articular infiltration. Changes in scores of pain, disability and quality of life questionnaires at 1, 3, 6 and 12 months of follow-up compared with baseline will be analysed. An MRI examination performed before infiltration will help to distinguish between exposed (with inflammation) and non-exposed (non-inflammation) groups with facet syndrome. The primary outcome will be the disability questionnaire (Roland Morris), and the secondary outcomes will be the score questionnaires for pain (Visual Analogue Scale), quality of life (EuroQol Quality of Life Questionnaire) and disability (Oswestry).Ethics and disseminationThe Internal Review Board approved this study, which started only after the approval number (5291417.0.0000.0071) was received. All recruited participants will receive a verbal explanation about the purpose of the study, and their decision to participate will be free and voluntary. All participants enrolled in the study will provide a signed informed consent form including confidentiality terms. The results obtained in this study will be presented at national and international conferences and published in peer-reviewed scientific journals to disseminate the knowledge.Trials registration numberNCT03304730; Pre-results.