Chronic Obstructive Pulmonary DiseaseNCT06505876
Effect of Oral Feeding on Patients With Chronic Obstructive Pulmonary Disease
A study testing Basic treatment, Oral Tube Feeding and Nasogastric Tube Feeding in people with Chronic Obstructive Pulmonary Disease, run by Chao Phya Abhaibhubejhr Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Basic treatment, Oral Tube Feeding and Nasogastric Tube Feeding
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of COPD confirmed by spirometry
- ≥18 years of age
- Sinus rhythm ≥50/min and < 120/min at inclusion
- Written informed consent
Who cannot join
- 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
About this study
Official title: Effect of Oral Feeding on Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Study
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
Read the 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
- Being tested
- Basic treatment, Oral Tube Feeding, Nasogastric Tube Feeding
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic treatmentBehavioural
including anti-infection therapy, blood pressure and blood glucose control
Oral Tube FeedingDevice
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 FeedingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Basic treatment; Device: Oral Tube Feeding |
| 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. Receives: Behavioral: Basic treatment; Device: Nasogastric Tube Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Obstructive Pulmonary Disease Assessment Test
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.
Measured: day 1 and day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chao Phya Abhaibhubejhr Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Copka Sonpashan, Chao Phya Abhaibhubejhr Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505876
- Sponsor's protocol ID
- Oral feeing-COPD
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Feeding on Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06505876
- Acronym / sponsor ID
- Oral feeing-COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chao Phya Abhaibhubejhr HospitalOther government
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Tube Feeding+Basic treatment | Experimental | Behavioral: Basic treatment, Device: Oral Tube FeedingThe 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 | Active comparator | Behavioral: Basic treatment, Device: Nasogastric Tube FeedingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of COPD confirmed by spirometry
- ≥18 years of age
- Sinus rhythm ≥50/min and < 120/min at inclusion
- Written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic treatmentincluding anti-infection therapy, blood pressure and blood glucose control | Behavioural | Nasogastric Tube Feeding+Basic treatment, Oral Tube Feeding+Basic treatment |
| Oral Tube FeedingBefore 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. | Device | Oral Tube Feeding+Basic treatment |
| Nasogastric Tube FeedingThe 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. | Device | Nasogastric Tube Feeding+Basic treatment |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Basic treatment, Oral Tube Feeding and Nasogastric Tube Feeding in people with Chronic Obstructive Pulmonary Disease, run by Chao Phya Abhaibhubejhr Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Obstructive Pulmonary Disease Assessment Test (time frame: day 1 and day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.