Effect of Oral Feeding on Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT06505876

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-06-30

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Oral Tube Feeding+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.

Group Type: EXPERIMENTAL

Basic treatment

Intervention Type: BEHAVIORAL

including anti-infection therapy, blood pressure and blood glucose control

Oral Tube Feeding

Intervention Type: DEVICE

Before each feeding, inside and outside of the tube was cleaned with water. During feeding, the patient should maintain a semi-reclining or sitting position with mouth opened, and the tube was inserted slowly and smoothly into the upper part of the esophagus by medical staffs while the appropriate depth of intubation was checked with the calibration markings on the tube wall. The distance from the incisors to the head part of the tube should be between 22-25 cm. However, the specific depth should be evaluated based on patients' feedback and adjusted accordingly. After insertion, the tail part of the tube should be put into a container full of water and the absence of continuous bubbles indicated a successful intubation. Then, the feeding was to be conducted three times per day with 50 ml per minute and 400-600ml for each feeding.

Nasogastric Tube Feeding+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.

Group Type: ACTIVE_COMPARATOR

Basic treatment

Intervention Type: BEHAVIORAL

including anti-infection therapy, blood pressure and blood glucose control

Nasogastric Tube Feeding

Intervention Type: DEVICE

The feeding was conducted once every 3-4 hours, with 200-300ml each time. The total feeding volume was determined based on daily requirements. The feeding content was formulated by the nutritionists based on the patient\'s condition and relevant guidelines to reach the energy demand as 20-25 kcal/kg/day and protein supplementation of 1.2-2.0 g/kg/day for both two groups. For patients with limited tube feeding compliance, we made appropriate adjustments to ensure that they were not at risk of severe malnutrition as much as possible.

Interventions

Basic treatment

including anti-infection therapy, blood pressure and blood glucose control

Intervention Type: BEHAVIORAL

Oral Tube Feeding

Before each feeding, inside and outside of the tube was cleaned with water. During feeding, the patient should maintain a semi-reclining or sitting position with mouth opened, and the tube was inserted slowly and smoothly into the upper part of the esophagus by medical staffs while the appropriate depth of intubation was checked with the calibration markings on the tube wall. The distance from the incisors to the head part of the tube should be between 22-25 cm. However, the specific depth should be evaluated based on patients' feedback and adjusted accordingly. After insertion, the tail part of the tube should be put into a container full of water and the absence of continuous bubbles indicated a successful intubation. Then, the feeding was to be conducted three times per day with 50 ml per minute and 400-600ml for each feeding.

Intervention Type: DEVICE

Nasogastric Tube Feeding

The feeding was conducted once every 3-4 hours, with 200-300ml each time. The total feeding volume was determined based on daily requirements. The feeding content was formulated by the nutritionists based on the patient\'s condition and relevant guidelines to reach the energy demand as 20-25 kcal/kg/day and protein supplementation of 1.2-2.0 g/kg/day for both two groups. For patients with limited tube feeding compliance, we made appropriate adjustments to ensure that they were not at risk of severe malnutrition as much as possible.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chao Phya Abhaibhubejhr Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Copka Sonpashan

The Research Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Oral feeing-COPD

Identifier Type: -

Identifier Source: org_study_id