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

NCT ID: NCT05810688

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-21

Study Completion Date

2024-02-20

Brief Summary

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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

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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.

Conditions

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Aspiration Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Eating rehabilitation training group

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

Group Type EXPERIMENTAL

eating rehabilitation training

Intervention Type OTHER

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

Control group

The control group will receive only usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Tsae Jyy, Wang

RN PhD professer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tase Jyy Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taipei University of Nursing and Health Sciences

Locations

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Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tase Jyy Wang, PhD

Role: CONTACT

886-911246130

Ling Yi Tai

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 34273953 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34087608 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27785002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33936197 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35028056 (View on PubMed)

Other Identifiers

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TPEVGH 2023-01-005AC

Identifier Type: -

Identifier Source: org_study_id

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