Clinical trial NCT05810688: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Aspiration Pneumonia
Keywords: elderly
Aspiration Pneumonia
eating rehabilitation training
removal of nasogastric tube
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Taipei Veterans General Hospital, Taiwan
First posted: 2023-04-12
Enrollment: 96
Sex: ALL
Minimum age (years): 75
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: nasogastric tube successfully removed and spent of time with removed successfully nasogastric tube
timeFrame: From date of randomization until the date of discharge from the cause, assessed up to one month.
Secondary outcomes:
measure: The re-insertion rate after one month of NG removal
timeFrame: From the date of discharge from any cause, assessed up to one month.
Other outcomes:
measure: 30 days unexpected re-admission rate.
timeFrame: From the date of discharge from any cause, assessed up to one month.
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Tase Jyy Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.