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Clinical Trials/NCT06505876
NCT06505876Not yet recruitingNot Applicable

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

Chao Phya Abhaibhubejhr Hospital0 sites80 target enrollmentStarted: July 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
80
Primary Endpoint
Chronic Obstructive Pulmonary Disease Assessment Test

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •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

Arms & Interventions

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.

Intervention: 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.

Intervention: 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.

Intervention: 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.

Intervention: Nasogastric Tube Feeding (Device)

Outcomes

Primary Outcomes

Chronic Obstructive Pulmonary Disease Assessment Test

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Chao Phya Abhaibhubejhr Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Copka Sonpashan

The Research Director

Chao Phya Abhaibhubejhr Hospital

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