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临床试验/NCT06505876
NCT06505876尚未招募不适用

Effect of Oral Feeding on Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Study

Chao Phya Abhaibhubejhr Hospital0 个研究点目标入组 80 人开始时间: 2024年7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
尚未招募
发起方
入组人数
80
主要终点
Chronic Obstructive Pulmonary Disease Assessment Test

研究概览

简要总结

This is a prospective, randomized controlled clinical trail that involved patients with Chronic Obstructive Pulmonary Disease.The goal of this clinical trial is to compare the clinical effect of Oral Tubes vs Nasogastric Tubes in patients with Chronic Obstructive Pulmonary Disease. The main questions it aims to answer are:

Compared to Nasogastric Tube Feeding, can the Oral esophageal Tube Feeding better improve the nutritional status and pulmonary infection

详细描述

This is a prospective, randomized controlled clinical trail that involved patients with Chronic Obstructive Pulmonary Disease.The goal of this clinical trial is to compare the clinical effect of Oral Tubes vs Nasogastric Tubes in patients with Chronic Obstructive Pulmonary Disease. The main questions it aims to answer are:

Compared to Nasogastric Tube Feeding, can the Oral esophageal Tube Feeding better improve the nutritional status and pulmonary infection

Participants will be divided into two groups randomly, with different nutritional support respectively.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •A diagnosis of COPD confirmed by spirometry
  • •≥18 years of age
  • •Sinus rhythm ≥50/min and < 120/min at inclusion
  • •Written informed consent

排除标准

  • •Known hypersensitivity to metoprolol or related derivatives
  • •Sinus bradycardia (resting heart rate < 50/min)
  • •Sick sinus syndrome unless treated with a pacemaker
  • •Atrial fibrillation/flutter
  • •Clinical signs or previous diagnosis of heart failure, angina pectoris, myocardial infarction, cerebrovascular disease, or critical peripheral ischemia

研究组 & 干预措施

Oral Tube Feeding+Basic treatment

Experimental

The patients were provided with 1) basic treatment including intracranial pressure reduction, anti-infection therapy, blood pressure and blood glucose control.

For the observation group, the nasogastric tube was removed, and Intermittent oro-esophageal tube feeding was initiated for nutrition support within 4 hours after completing the admission assessment, following the standard Intermittent oro-esophageal tube feeding procedure.

干预措施: Basic treatment (Behavioral)

Oral Tube Feeding+Basic treatment

Experimental

The patients were provided with 1) basic treatment including intracranial pressure reduction, anti-infection therapy, blood pressure and blood glucose control.

For the observation group, the nasogastric tube was removed, and Intermittent oro-esophageal tube feeding was initiated for nutrition support within 4 hours after completing the admission assessment, following the standard Intermittent oro-esophageal tube feeding procedure.

干预措施: Oral Tube Feeding (Device)

Nasogastric Tube Feeding+Basic treatment

Active Comparator

The patients were provided with 1) basic treatment including intracranial pressure reduction, anti-infection therapy, blood pressure and blood glucose control.

Patients in the control group were provided with nutrition support by the indwelling nasogastric tube. The entire feeding process strictly followed the standardized procedure for nasogastric feeding.

干预措施: Basic treatment (Behavioral)

Nasogastric Tube Feeding+Basic treatment

Active Comparator

The patients were provided with 1) basic treatment including intracranial pressure reduction, anti-infection therapy, blood pressure and blood glucose control.

Patients in the control group were provided with nutrition support by the indwelling nasogastric tube. The entire feeding process strictly followed the standardized procedure for nasogastric feeding.

干预措施: Nasogastric Tube Feeding (Device)

结局指标

主要结局

Chronic Obstructive Pulmonary Disease Assessment Test

时间窗: day 1 and day 15

It is a simple questionnaire used to assess symptoms and quality of life in patients with Chronic Obstructive Pulmonary Disease (COPD). The scale consists of 8 items covering the most common symptoms and impacts on quality of life in COPD patients, such as cough, sputum production, and breathlessness. Each item is graded on a scale of 0 to 5, where patients select the score that best reflects their experience. The total score ranges from 0 to 40, with higher scores indicating more severe symptoms.

次要结局

未报告次要终点

研究者

发起方
Chao Phya Abhaibhubejhr Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Copka Sonpashan

The Research Director

Chao Phya Abhaibhubejhr Hospital

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