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临床试验/NCT06829017
NCT06829017已完成不适用

Pilot Implementation and Evaluation of the Effectiveness of the Postoperative Hypothermia Management Care Bundle

Hacettepe University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Care bundles compliance assessment form for postoperative hypothermia management

研究概览

简要总结

Inadvertent perioperative hypothermia (IPH) is a common complication in surgical patients, with incidence rates ranging between 50% and 90% in anaesthetised individuals. This study aims to pilot and evaluate the effectiveness of a Postoperative Hypothermia Management Care Bundle developed based on standardised, evidence-based practices.

The study will be conducted using a mixed-methods design in two phases.

In the first phase, the care bundle will be piloted over six months in the Cardiovascular Surgery Intensive Care Unit.

In the second phase, the bundle's effectiveness will be assessed using both quantitative and qualitative data.

The study population includes nurses working in the relevant intensive care unit who meet inclusion criteria and volunteer to participate.

Data collection tools include:

Nurse Descriptive Information Form

Postoperative Hypothermia Management Care Bundle Checklist

Care Bundle Compliance Assessment Form

Semi-structured Nurse Interview Questionnaire (qualitative)

Patient Postoperative Hypothermia Follow-up Form

Quantitative data will be analysed using descriptive statistics. Compliance with the care bundle will be calculated as the ratio of patients who received all care bundle parameters to those who should have received them. A compliance rate below 95% will be considered unsuccessful. Qualitative data will be analysed using Colaizzi's seven-step phenomenological method.

详细描述

Background and Rationale

Inadvertent perioperative hypothermia (IPH) is one of the most common perioperative problems in surgical patients. In the literature, IPH rates in anesthetized patients are reported between 50-90%. Guidelines for preventing and managing IPH in surgical patients have been developed. Although there are clinical practice guidelines for the management of IPH, the incidence of IPH in surgical patients is still high. Reducing the incidence of IPH in surgical patients depends on good management of hypothermia in the perioperative process, and nurses have important responsibilities at every stage of the perioperative process in the management of IPH. Nurses, who play a key role in the multidisciplinary team in the management of IPH, still experience some problems in the management of hypothermia. Good management of IPH, which is a preventable problem in the surgical process, may be possible with evidence-based standardization of practices in the perioperative process and systematic implementation of these practices.

Care Bundles for Hypothermia Management

In recent years, Care Bundles (CB) have been used to standardize nursing practices based on evidence and to improve the quality of care. CB is defined as a set of evidence-based practices used to standardize care and treatment. CBs are reported to have many benefits such as providing easy management of conditions requiring special care, reducing complications, increasing communication within the team, improving the quality of care, and providing supervision. In addition, it has been reported that the use of CB increases the satisfaction of patients and nurses and job satisfaction of nurses, reduces unnecessary applications in nursing care, and improves negative patient outcomes that may result from inadequate care. In the literature, there is a CB developed for the management of perioperative hypothermia. The perioperative thermal CB developed by Duff et al. (2018) includes three elements: risk assessment, body temperature monitoring, and active warming. The three elements in this CB are recommendations for preoperative, intraoperative, and postoperative processes, and it is evident that the majority of the applications are for the intraoperative phase. In the study, it was found that compliance with the CB, especially the practices in the intraoperative process, was low. It is thought that the development and use of a CB specific to each stage of the perioperative process in the management of IPH will increase the applicability of the CB and compliance with the bundle. In the literature, there is no CB developed for the management of hypothermia in the postoperative period. Therefore, a CB specific to the postoperative process was developed to standardize nursing care for hypothermia in surgical patients, improve patient outcomes, and increase the quality of care. This CB was prepared in line with the approaches recommended by the Institute for Healthcare Improvement (IHI) for the management of postoperative hypothermia.

Study Objectives This study evaluates the pilot implementation and effectiveness of the postoperative hypothermia management CB developed within the scope of the research.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Working as a nurse in Cardiovascular Surgery Intensive Care Unit for at least 6 months
  • •Volunteering to participate in the study
  • •For patients to be cared for during the pilot implementation of the care bundle:
  • •18 years of age or older
  • •Being in the first 24 hours of postoperative follow-up in the Cardiovascular Surgery Intensive Care Unit
  • •He/she or his/her legal representative has given consent to participate in the study

排除标准

  • •Leaving the Cardiovascular Surgery Intensive Care Unit before the completion of the study period
  • •Unwillingness to continue working
  • •For patients to be cared for during the piloting of the care package:
  • •- Emergency surgical operations, patients with abnormal thermoregulation such as malignant hyperthermia and neuroleptic malignant syndrome and patients with ASA IV-V

研究组 & 干预措施

the pilot implementation and effectiveness of the postoperative hypothermia management care bundle

Other

干预措施: Postoperative Hypothermia Management Care Bundle (Other)

结局指标

主要结局

Care bundles compliance assessment form for postoperative hypothermia management

时间窗: 15 August 2025-28 February 2026

This form was developed by the researchers to evaluate the nurses' application of the care bundle to the patients. The boxes 'applied', 'not applied' if not applied, and 'not filled' if the control form is not marked will be ticked on the compliance assessment form in which the care bundle parameters are applied. Within the scope of this form, the compliance rate of the care bundle will be calculated. The rate found with this calculation will show the success of compliance with the maintenance bundle. In the calculation, the compliance rate will be calculated by dividing the number of patients to whom all parameters of the care bundle are fully implemented within the scope of the research by the number of patients to whom the care bundle parameters should be implemented. In this calculation, if the compliance rate is below 95%, it means that compliance with the care bundle is unsuccessful.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Balkan

Research assistant

Hacettepe University

研究点 (1)

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