Effect of Oral Feeding on Patients With Chronic Obstructive Pulmonary Disease

Not Applicable

Not yet recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Behavioral: Basic treatment; Device: Nasogastric Tube Feeding; Device: Oral Tube Feeding

• Registration Number: NCT06505876
• Lead Sponsor: Chao Phya Abhaibhubejhr Hospital

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 Timeline

• Status Verified: 2024-07
• Study Start: 2024-07
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-11
• Study First Posted: 2024-07-17
• Last Update Posted: 2024-07-17
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasogastric Tube Feeding+Basic treatment	Nasogastric Tube Feeding	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.
Oral Tube Feeding+Basic treatment	Basic treatment	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.
Oral Tube Feeding+Basic treatment	Oral Tube Feeding	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.
Nasogastric Tube Feeding+Basic treatment	Basic treatment	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.

Primary Outcome Measures

Name	Time	Method
Chronic Obstructive Pulmonary Disease Assessment Test	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.