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Eating Rehabilitation Training for Timely Removal of Nasogastric Tube in Elderly Patients

Primary Purpose

Aspiration Pneumonia

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
eating rehabilitation training
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Aspiration Pneumonia focused on measuring elderly, Aspiration Pneumonia, eating rehabilitation training, removal of nasogastric tube

Eligibility Criteria

75 Years - 110 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients than or equal to 75 years old Clear consciousness Diagnosed with aspiration pneumonia (the main diagnostic disease code is ICD-9-CM: 507; ICD-10-CM: J69) Those who were hospitalized for more than 24 hours and had a nasogastric tube inserted for the first time within 1 month Those who can communicate in Chinese or Taiwanese The doctor judges that the condition is stable, such as: body temperature < 37.5°C, heart rate < 100 beats/min, respiratory rate < 24/min, systolic blood pressure > 90 mmHg and fingertip pulse oximeter saturation greater than 90% Exclusion Criteria: Patients who have been placed in a nasogastric tube or gastrostomy for force-feeding before seeing a doctor Diagnosed with other neurological disorders, such as Parkinson's disease, multiple sclerosis, polio, dermatomyosclerosis inflammation, and myasthenia gravis Those who use oxygen masks or respirators

Sites / Locations

  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Eating rehabilitation training group

Control group

Arm Description

The intervention group will receive eating rehabilitation training, including oral care, saliva gland massage, oral exercise, feeding strategy, and swallowing skill education

The control group will receive only usual care.

Outcomes

Primary Outcome Measures

nasogastric tube successfully removed and spent of time with removed successfully nasogastric tube
It was observed from the bedside that the subjects had successfully removed the nasogastric tube according to the doctor's advice before being discharged from the hospital. The criteria for successfully removing the nasogastric tube in the ward include: the research subject can accept oral medication, can eat about 1000ml per day, and has no cough when eating. In addition to the above circumstances, when removing the nasogastric tube, the doctor's confirmation and removal of the doctor's order are also required

Secondary Outcome Measures

The re-insertion rate after one month of NG removal
Subjects whose nasogastric tube was removed during hospitalization were followed up at the bedside or by telephone once a week after the removal of the nasogastric tube to find out whether there was any unexpected nasogastric tube re-insertion within 30 days after the removal of the nasogastric tube.

Full Information

First Posted
March 19, 2023
Last Updated
March 31, 2023
Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05810688
Brief Title
Eating Rehabilitation Training for Timely Removal of Nasogastric Tube in Elderly Patients
Official Title
Aspiration Pneumonia is High Morbidity and Mortality Rate. Nasogastric Tube Insertion is an Emergency Medical Treatment. The Results of the Successful Strategy for Removing Senior Aspiration Pneumonia Patient's Nasogastric Tubes.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
February 20, 2024 (Anticipated)
Study Completion Date
February 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aspiration pneumonia is a common complication in senior patients with high morbidity and mortality rate. The decline of physical function among elders can easily lead to swallowing disorders, and nasogastric (NG) tube insertion is an emergency medical treatment that provides patients with adequate hydration and nutrition. However, NG is easily dislodged after a long duration of placement; furthermore, lacking accurate feeding skills could also lead to aspiration pneumonia.
Detailed Description
Aspiration pneumonia is a common complication in senior patients with high morbidity and mortality rate. The decline of physical function among elders can easily lead to swallowing disorders, and nasogastric (NG) tube insertion is an emergency medical treatment that provides patients with adequate hydration and nutrition. However, NG is easily dislodged after a long duration of placement; furthermore, lacking accurate feeding skills could also lead to aspiration pneumonia. An appropriate NG care model to lower feeding complications is an essential issue. The purpose of this study is to investigate the efficacy of eating rehabilitation training in the removal of NG tubes among elderly patients with aspiration pneumonia. This is an experimental, convenient sampling study. We enrolled first-time NG tube insertion friends and complicated with aspiration pneumonia. All patients in this study were from the medical ward of a tertiary center in northern Taiwan. The target numbers are ninety-six patients. The eligible subjects will be randomized to the experimental and the control group. The experimental group will receive eating rehabilitation training, including oral care, saliva gland massage, oral exercise, feeding strategy, and swallowing skill education. The control group will receive routine medical care. The endpoint of this study includes 1. The timing of NG removal, 2. The re-insertion rate after one month of NG removal, 3. 30 days unexpected re-admission rate. The characteristics and distribution of variables were described by percentage, mean, and standard deviation. The Chi-square test was used to analyze the difference between-group differences on the 30 days of NG re-insertion and re-admission rate. The timing of NG removal between the two groups was analyzed by Kaplan-Meier survival. All statistical analyses were performed on Statistical Package for Social Sciences (SPSS) version 22.0. This study's results provide caregivers with more successful strategy for removing senior aspiration pneumonia patients' nasogastric tubes and improving early oral intake and patients' quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspiration Pneumonia
Keywords
elderly, Aspiration Pneumonia, eating rehabilitation training, removal of nasogastric tube

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eating rehabilitation training group
Arm Type
Experimental
Arm Description
The intervention group will receive eating rehabilitation training, including oral care, saliva gland massage, oral exercise, feeding strategy, and swallowing skill education
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive only usual care.
Intervention Type
Other
Intervention Name(s)
eating rehabilitation training
Intervention Description
The experimental group will receive eating rehabilitation training, including oral care, saliva gland massage, oral exercise, feeding strategy, and swallowing skill education.
Primary Outcome Measure Information:
Title
nasogastric tube successfully removed and spent of time with removed successfully nasogastric tube
Description
It was observed from the bedside that the subjects had successfully removed the nasogastric tube according to the doctor's advice before being discharged from the hospital. The criteria for successfully removing the nasogastric tube in the ward include: the research subject can accept oral medication, can eat about 1000ml per day, and has no cough when eating. In addition to the above circumstances, when removing the nasogastric tube, the doctor's confirmation and removal of the doctor's order are also required
Time Frame
From date of randomization until the date of discharge from the cause, assessed up to one month.
Secondary Outcome Measure Information:
Title
The re-insertion rate after one month of NG removal
Description
Subjects whose nasogastric tube was removed during hospitalization were followed up at the bedside or by telephone once a week after the removal of the nasogastric tube to find out whether there was any unexpected nasogastric tube re-insertion within 30 days after the removal of the nasogastric tube.
Time Frame
From the date of discharge from any cause, assessed up to one month.
Other Pre-specified Outcome Measures:
Title
30 days unexpected re-admission rate.
Description
It refers to the rate of rehospitalization due to pneumonia on the 30th day from the date of discharge for patients who are unexpectedly readmitted within the 30th day from the date of discharge from the medical records of each research subject.
Time Frame
From the date of discharge from any cause, assessed up to one month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients than or equal to 75 years old Clear consciousness Diagnosed with aspiration pneumonia (the main diagnostic disease code is ICD-9-CM: 507; ICD-10-CM: J69) Those who were hospitalized for more than 24 hours and had a nasogastric tube inserted for the first time within 1 month Those who can communicate in Chinese or Taiwanese The doctor judges that the condition is stable, such as: body temperature < 37.5°C, heart rate < 100 beats/min, respiratory rate < 24/min, systolic blood pressure > 90 mmHg and fingertip pulse oximeter saturation greater than 90% Exclusion Criteria: Patients who have been placed in a nasogastric tube or gastrostomy for force-feeding before seeing a doctor Diagnosed with other neurological disorders, such as Parkinson's disease, multiple sclerosis, polio, dermatomyosclerosis inflammation, and myasthenia gravis Those who use oxygen masks or respirators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tase Jyy Wang, PhD
Phone
886-911246130
Email
tasejyy@ntunhs.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Ling Yi Tai
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tase Jyy Wang, PhD
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tai Ling-Yi

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34273953
Citation
Chen S, Kent B, Cui Y. Interventions to prevent aspiration in older adults with dysphagia living in nursing homes: a scoping review. BMC Geriatr. 2021 Jul 17;21(1):429. doi: 10.1186/s12877-021-02366-9.
Results Reference
background
PubMed Identifier
34087608
Citation
Averin A, Shaff M, Weycker D, Lonshteyn A, Sato R, Pelton SI. Mortality and readmission in the year following hospitalization for pneumonia among US adults. Respir Med. 2021 Aug-Sep;185:106476. doi: 10.1016/j.rmed.2021.106476. Epub 2021 May 21.
Results Reference
background
PubMed Identifier
27785002
Citation
Baijens LW, Clave P, Cras P, Ekberg O, Forster A, Kolb GF, Leners JC, Masiero S, Mateos-Nozal J, Ortega O, Smithard DG, Speyer R, Walshe M. European Society for Swallowing Disorders - European Union Geriatric Medicine Society white paper: oropharyngeal dysphagia as a geriatric syndrome. Clin Interv Aging. 2016 Oct 7;11:1403-1428. doi: 10.2147/CIA.S107750. eCollection 2016.
Results Reference
background
PubMed Identifier
33936197
Citation
Chauhan D, Varma S, Dani M, Fertleman MB, Koizia LJ. Nasogastric Tube Feeding in Older Patients: A Review of Current Practice and Challenges Faced. Curr Gerontol Geriatr Res. 2021 Jan 21;2021:6650675. doi: 10.1155/2021/6650675. eCollection 2021.
Results Reference
background
PubMed Identifier
35028056
Citation
Chen HH, Lin PY, Lin CK, Lin PY, Chi LY. Effects of oral exercise on tongue pressure in Taiwanese older adults in community day care centers. J Dent Sci. 2022 Jan;17(1):338-344. doi: 10.1016/j.jds.2021.10.017. Epub 2021 Nov 27.
Results Reference
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Eating Rehabilitation Training for Timely Removal of Nasogastric Tube in Elderly Patients

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