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临床试验/NCT06812182
NCT06812182已完成不适用

Effectiveness a Nurse Guided Enhanced Recovery Pathway on Postoperative Respiratory Tract Infection in Hepatico-Pancreatic -Biliary Surgery

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5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
60
试验地点
1
主要终点
postoperative pulmonary infection

研究概览

简要总结

Objectives: Evaluate the effect of a nurse guided enhanced recovery pathway on postoperative respiratory tract infection in Hepatico-Pancreatic -Biliary surgery [ pre-operative patient counselling for postoperative respiratory physiotherapy techniques and emphasis on perfect training]. Design: Quasi-experimental study. Setting: The study was conducted in surgical department, operation unit and intensive care unit at AlRajhy liver hospital. Subjects: Sixty patient undergoing hepatobiliary pancreatic surgeries. The sample was divided into two groups; control and study group (30patient each). The control started the first then the study group. Tools: Three tools were used. Tool I: Patient assessment sheet. Tool II: Clinical pathway protocol. Tool III: Clinical outcome evaluation. The control group received tools I and III only while study group received the three tools including clinical pathway protocol [tool II].

详细描述

: Sixty patient undergoing hepatobiliary pancreatic surgeries. The sample was divided into two groups; control and study group [30patient each]. The control started the first then the study group.

The sample size was calculated according to Epi Info 2000. A sample size was selected using a special formula based on prevalence of disease at a confidence interval of 95% and precision of (2%). The sample was increased by 10% to overcome problems related to non-responses and missing data. The power of study was 80%. Considering the following matching criteria age group, sex, diagnosis, comorbidity diseases.

The patients' inclusion criteria: Age 18-65 years old, able to communicate and Patients without vital failure [renal, hepatic, cardiac].

The patients' exclusion criteria: Past history of other organ cancer and patient refusal.

Tools:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •able to communicate
  • •Patients without vital failure [renal, hepatic, cardiac].

排除标准

  • •Past history of other organ cancer
  • •patient refusal

研究组 & 干预措施

control

No Intervention

All the patients admitted to surgical department during the period from early Augusts 2023until the end November 2023 matching the inclusion criteria for this study were included in the control group. The control group contained 30 patients with the same designed criteria. The control group received routine daily care of the hospital. For the control group, the two designed study tools used to assess the patients daily and detect the clinical outcomes of the patients [tool I and tool III] only.

study group

Experimental

educational training sessions were provided to care providers including the purpose and the process of implementing the pathway for one week. Following the training thee researchers started to make recruitment and screen for the study group, the researchers received consent from administration to start the data for the study group. The oral and written consent from the patient was also done, to allow the researchers to observe, make daily assessment and manage the patients according to the designed clinical pathway.

After completion of the recruitment and screening, all patients admitted to the surgical unit during the five months period from first December 2023 until the end of April 2024 were assessed and managed as study group. The study group also estimated 30 patients that met the inclusion criteria. For the study group, the three designed study tools used to assess the patients daily and detect the clinical outcomes of the patients [tool I, tool II and tool III]

干预措施: nurse guided clinical pathway (Behavioral)

结局指标

主要结局

postoperative pulmonary infection

时间窗: 6 hours postoperatively, day 1, Day 2, and day 3

Presence of 3 of the following: tachypnea more than 30/min, expectoration, and hypoxia, respiratory distress

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

Ayman Abd El-Khalek Mohammed Glala

lecturer

Assiut University

研究点 (1)

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