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

Aspiration Pneumonia Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05810688
• Other study ID #: TPEVGH 2023-01-005AC
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2023
• Est. completion date: February 20, 2024

Study information

• Verified date: March 2023
• Source: National Taipei University of Nursing and Health Sciences
• Contact: Tase Jyy Wang, PhD
• Phone: 886-911246130
• Email: tasejyy[@]ntunhs.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: February 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years to 110 Years

Eligibility

Inclusion Criteria:

1. Patients than or equal to 75 years old

2. Clear consciousness

3. Diagnosed with aspiration pneumonia (the main diagnostic disease code is ICD-9-CM:

507; ICD-10-CM: J69)

4. Those who were hospitalized for more than 24 hours and had a nasogastric tube inserted for the first time within 1 month

5. Those who can communicate in Chinese or Taiwanese

6. 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:

1. Patients who have been placed in a nasogastric tube or gastrostomy for force-feeding before seeing a doctor

2. Diagnosed with other neurological disorders, such as Parkinson's disease, multiple sclerosis, polio, dermatomyosclerosis inflammation, and myasthenia gravis

3. Those who use oxygen masks or respirators

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Pneumonia
• Pneumonia, Aspiration

Intervention

Other:
• eating rehabilitation training
The experimental group will receive eating rehabilitation training, including oral care, saliva gland massage, oral exercise, feeding strategy, and swallowing skill education.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences	Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	30 days unexpected re-admission rate.	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.	From the date of discharge from any cause, assessed up to one month.
Primary	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	From date of randomization until the date of discharge from the cause, assessed up to one month.
Secondary	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.	From the date of discharge from any cause, assessed up to one month.