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Impact of fibrinogen-to-erythrocyte suspension ratio on mortality and functional outcomes in major perioperative bleeding (Approximate Dose-Equivalent of Fibrinogen-to-Erythrocyte Suspension (ADEFES) study): protocol for a prospective observational study

Por: Demir · Z. A. · Kavak Akelma · F. · Akca · O. · Koltka · K. · Dincer · B. · Kocyigit · M. · Tuna · A. T. · Sayın · J. · Yıldırım Ar · A. · Kuvaki · B. · Aykut · A. · Sahin · A. S. · Aydın Güzey · N. · ADEFES Investigators · Yigit · Akyol · Akel · Argun · Aydın · Saracoglu · Canb
Introduction

Early and balanced replacement of blood products appears to be the key factor in improving outcomes of major bleeding patients including acute trauma, cardiac, obstetric and transplant surgery patients. Definitive clinical guidance regarding the optimal ratio of blood products, including those containing fibrinogen, is still lacking. Therefore, we tested the hypothesis that increasing the fibrinogen content to erythrocyte suspension ratio improves the mortality and functional outcomes of patients undergoing surgeries with expected major bleeding.

Methods and analysis

The Approximate Dose-Equivalent of Fibrinogen-to-Erythrocyte Suspension (ADEFES) ratio is a multicentre, prospective, observational, cohort study of patients undergoing major surgical procedures with expected major perioperative bleeding (ie, requiring packed red blood cells (PRBC)>4U/24 hours). For 5U of cryoprecipitate and 1.5 U of fresh frozen plasma (FFP), the approximate dose-equivalent for fibrinogen is considered as 1 gram of fibrinogen. Association of the ADEFES ratio at 24 hours will be assessed on the primary objective, which will consist of the composite of 30-day all-cause mortality, 30-day bleeding-specific mortality and the ‘highly-dependent scores’ of Katz index of independence in activities of daily living.

Ethics and dissemination

The study protocol was approved by the Ethics Committee of Ankara Bilkent City Hospital (approval no. E2-23-4265, dated 07 June 2023; Chair: Prof. Dr. F.E. Canpolat) and by the institutional review boards of all participating centres. The study will be conducted in accordance with the principles of the Declaration of Helsinki and the Strengthening the Reporting of Observational Studies in Epidemiology guidelines, as well as in compliance with national regulations on data protection and Good Clinical Practice standards. Written informed consent will be obtained from all participants prior to inclusion in the study.

The results of this study will be disseminated through peer-reviewed scientific journals, presentations at national and international conferences, and communication with relevant stakeholders including clinical practitioners and healthcare institutions. If applicable, study outcomes will also be shared via institutional newsletters and digital platforms to reach a broader audience in the medical community.

Trial registration number

NCT06021184.

Alarm Management Practices Among Intensive Care Nurses: An Observational Study

ABSTRACT

Background

Alarm fatigue has the potential to have significant consequences for patient safety, and the critical role of intensive care nurses in alarm management is an important component of this process.

Objectives

This study aimed to investigate the alarm management practices of intensive care nurses.

Design

This study utilised an observational design.

Methods

The study was conducted in the intensive care unit of a university hospital in western Türkiye with 21 nurses. To avoid influencing their behaviour, the primary purpose of the observation was not disclosed to the nurses. Two observers used an observation form to record alarms, nurse interventions and intervention times. Environmental noise levels were also measured and recorded during the observation periods.

Results

Over 118 h of observation, 460 alarms were recorded. Most alarms (80.4%) were generated by monitors, and 36.3% were due to deviations in the patient's clinical status. It was found that 53.3% of alarms were not responded to, and 73.7% were controlled. Environmental noise levels ranged from 41.90 to 83.10 dB.

Conclusions

The control, intervention and response times to alarms by intensive care nurses varied based on the alarm cause and their workload at the time. High environmental noise levels were also observed, which may impact alarm response.

Implications for Practice

The centralised location of the nurses' station, preparation of treatments at the bedside and proximity to patients contribute positively to alarm management. Recommendations to reduce technical alarms include appropriate device calibration; secure technical connections; and appropriate use of ECG electrodes, sensors and medical supplies. Setting appropriate alarm limits by primary nurses and evaluating ICU noise levels for necessary adjustments are crucial.

Reporting Method

The study was reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklists.

Patient Contributions

No patient or public contribution.

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