跳至主要内容
临床试验/NCT05810688
NCT05810688招募中不适用

Aspiration Pneumonia is High Morbidity and Mortality Rate. Nasogastric Tube Insertion is an Emergency Medical Treatment. The Results of the Successful Strategy for Removing Senior Aspiration Pneumonia Patient's Nasogastric Tubes.

National Taipei University of Nursing and Health Sciences1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年2月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
96
试验地点
1
主要终点
nasogastric tube successfully removed and spent of time with removed successfully nasogastric tube

研究概览

简要总结

Aspiration pneumonia is a common complication in senior patients with high morbidity and mortality rate. The decline of physical function among elders can easily lead to swallowing disorders, and nasogastric (NG) tube insertion is an emergency medical treatment that provides patients with adequate hydration and nutrition. However, NG is easily dislodged after a long duration of placement; furthermore, lacking accurate feeding skills could also lead to aspiration pneumonia.

详细描述

Aspiration pneumonia is a common complication in senior patients with high morbidity and mortality rate. The decline of physical function among elders can easily lead to swallowing disorders, and nasogastric (NG) tube insertion is an emergency medical treatment that provides patients with adequate hydration and nutrition. However, NG is easily dislodged after a long duration of placement; furthermore, lacking accurate feeding skills could also lead to aspiration pneumonia. An appropriate NG care model to lower feeding complications is an essential issue. The purpose of this study is to investigate the efficacy of eating rehabilitation training in the removal of NG tubes among elderly patients with aspiration pneumonia. This is an experimental, convenient sampling study. We enrolled first-time NG tube insertion friends and complicated with aspiration pneumonia. All patients in this study were from the medical ward of a tertiary center in northern Taiwan. The target numbers are ninety-six patients. The eligible subjects will be randomized to the experimental and the control group. The experimental group will receive eating rehabilitation training, including oral care, saliva gland massage, oral exercise, feeding strategy, and swallowing skill education. The control group will receive routine medical care. The endpoint of this study includes 1. The timing of NG removal, 2. The re-insertion rate after one month of NG removal, 3. 30 days unexpected re-admission rate. The characteristics and distribution of variables were described by percentage, mean, and standard deviation. The Chi-square test was used to analyze the difference between-group differences on the 30 days of NG re-insertion and re-admission rate. The timing of NG removal between the two groups was analyzed by Kaplan-Meier survival. All statistical analyses were performed on Statistical Package for Social Sciences (SPSS) version 22.0. This study's results provide caregivers with more successful strategy for removing senior aspiration pneumonia patients' nasogastric tubes and improving early oral intake and patients' quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
75 Years 至 110 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients than or equal to 75 years old
  • Clear consciousness
  • Diagnosed with aspiration pneumonia (the main diagnostic disease code is ICD-9-CM: 507; ICD-10-CM: J69)
  • Those who were hospitalized for more than 24 hours and had a nasogastric tube inserted for the first time within 1 month
  • Those who can communicate in Chinese or Taiwanese
  • The doctor judges that the condition is stable, such as: body temperature < 37.5°C, heart rate < 100 beats/min, respiratory rate < 24/min, systolic blood pressure > 90 mmHg and fingertip pulse oximeter saturation greater than 90%

排除标准

  • Patients who have been placed in a nasogastric tube or gastrostomy for force-feeding before seeing a doctor
  • Diagnosed with other neurological disorders, such as Parkinson's disease, multiple sclerosis, polio, dermatomyosclerosis inflammation, and myasthenia gravis
  • Those who use oxygen masks or respirators

结局指标

主要结局

nasogastric tube successfully removed and spent of time with removed successfully nasogastric tube

时间窗: From date of randomization until the date of discharge from the cause, assessed up to one month.

It was observed from the bedside that the subjects had successfully removed the nasogastric tube according to the doctor's advice before being discharged from the hospital. The criteria for successfully removing the nasogastric tube in the ward include: the research subject can accept oral medication, can eat about 1000ml per day, and has no cough when eating. In addition to the above circumstances, when removing the nasogastric tube, the doctor's confirmation and removal of the doctor's order are also required

次要结局

  • The re-insertion rate after one month of NG removal(From the date of discharge from any cause, assessed up to one month.)

研究者

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

Tsae Jyy, Wang

RN PhD professer

National Taipei University of Nursing and Health Sciences

研究点 (1)

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