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临床试验/NCT04347395
NCT04347395已完成不适用

Prevention of Respiratory Infections in Older Patients During and After Hospitalisation: A Randomised Controlled Trial

Changi General Hospital2 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2016年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
123
试验地点
2
主要终点
In Older Patients (>65 years age)

研究概览

简要总结

This randomized controlled trial in older hospitalized patients found that a respiratory care bundle intervention did not significantly reduce the incidence of respiratory infections compared to usual care for the index admission. However, time to next admission for respiratory infection was significantly longer with the intervention compared to usual care.

Aim: To evaluate whether a respiratory care bundle, compared to usual care, reduces respiratory infections during and after hospitalization.

Methods: In this open-label, single-centre randomized controlled trial, we recruited patients >65 years of age and admitted <72 hours for non-respiratory conditions to a novel respiratory care bundle intervention (whole bed tilt, swallow screen, chlorhexidine mouth wash, and pneumococcal and influenza vaccinations) or usual care. Participants were followed up for 12 months. The primary endpoint was the development of respiratory infection during the index admission. The secondary endpoint was the time to next admission for respiratory infection.

详细描述

Background:

Hospital-acquired infections impact patient recovery and increase risk of deterioration. Pneumonia is the second commonest cause of death in Singapore accounting for 19% of deaths in 2014. Hospital acquired pneumonia (HAP) or nosociomal pneumonia refers to any pneumonia contracted by a patient in a hospital at least 48-72 hours after admission and is usually caused by a bacterial infection, rather than a virus. It is the most prevalent hospital-acquired infection, and has the highest mortality among the hospital-acquired infections (20-50%) . Local audit data has shown that around 60% of deaths in hospitalised older patients are due to pneumonia, of which a significant proportion are due to HAP or health care associated pneumonia (HCAP).

A meta-analysis of respiratory studies has shown low numbers of studies evaluating novel antimicrobial agents for hospital-acquired pneumonia (15.9%) suggesting further research or novel approaches are needed. The prevalence of nosociomal pneumonia in a European study was 13.9%. Pneumonia acquired during periods of hospitalisation has a high morbidity, mortality and increased hospital length of stay (LOS). Audit of the 2014 data from the Geriatric Mortality meetings has shown all cause pneumonia (community acquired pneumonia (CAP) and HAP) is 55%. Currently this data is being analysed to calculate the proportion of deaths attributable to HAP vs CAP.

The pathophysiology of pneumonia in the elderly is primarily due to aspiration pneumonia (ASP). ASP comprises predominantly two pathological conditions: airspace infiltration with bacterial pathogens and dysphagia-associated aspiration. The primary route of infection is believed to be through microaspiration of organisms that have colonised the oropharynx and gastrointestinal tract. Hospitalised patients become colonised with microorganisms from the hospital environment within 48 hours and severity of respiratory infection is related to the number and virulence of these microorganisms as well as the hosts immune response.

Swallowing difficulties, poor oral hygiene and reduced immune response are inherent in the older population contributing to an increased risk of HAP. In addition, older patients have an increased risk of aspiration of gastric contents due to a laxity of lower oesphageal sphincter, an anatomical sphincter that relies on diaphragmatic function. Many older patients locally are fed via naso-gastric tube and the presence of a naso-gastric tube increases the risk of aspiration pneumonia occuring during hospitalisation. Supine positioning also predisposes to micro aspiration from the oropharynx and stomach with many patients placed routinelyin a supine position to undertake their basic care needs. Positioning in the semi recumbant position has been shown to reduce microaspiration with elevations of 30-45 degrees by improving supraglottic drainage.

研究设计

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

入排标准

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

入选标准

  • hospitalized geriatric patients >65 years age
  • likely hospital length of stay >72 hours.

排除标准

  • participants < 65 years;
  • spinal cord injury;
  • pneumonia or chest infection as admission diagnosis;
  • active cancer of the respiratory tract;
  • pressure ulcer grade 3, grade 4 or unstageable;
  • hospital admission likely to be <72 hours.

结局指标

主要结局

In Older Patients (>65 years age)

时间窗: 9.5months

To reduce the incidence of HAP

次要结局

  • In Older Patients (>65 years age)(9.5months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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