NCT05810688

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
Last Updated

April 12, 2023

Status Verified

March 1, 2023

Enrollment Period

12 months

First QC Date

March 19, 2023

Last Update Submit

March 31, 2023

Conditions

Aspiration Pneumonia

Keywords

elderlyAspiration Pneumoniaeating rehabilitation trainingremoval of nasogastric tube

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The re-insertion rate after one month of NG removal

    From the date of discharge from any cause, assessed up to one month.

Other Outcomes (1)

  • 30 days unexpected re-admission rate.

    From the date of discharge from any cause, assessed up to one month.

Study Arms (2)

Eating rehabilitation training group

EXPERIMENTAL

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

Other: eating rehabilitation training

Control group

NO INTERVENTION

The control group will receive only usual care.

Interventions

eating rehabilitation trainingOTHER

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

Eating rehabilitation training group

Eligibility Criteria

Age75 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Related Publications (5)

  • 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.

    PMID: 34273953BACKGROUND

  • 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.

    PMID: 34087608BACKGROUND

  • 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.

    PMID: 27785002BACKGROUND

  • 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.

    PMID: 33936197BACKGROUND

  • 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.

    PMID: 35028056BACKGROUND

MeSH Terms

Conditions

Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Tase Jyy Wang, PhD

    National Taipei University of Nursing and Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tase Jyy Wang, PhD

CONTACT

886-911246130tasejyy@ntunhs.edu.tw

Ling Yi Tai

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN PhD professer

Study Record Dates

First Submitted

March 19, 2023

First Posted

April 12, 2023

Study Start

February 21, 2023

Primary Completion

February 20, 2024

Study Completion

February 20, 2024

Last Updated

April 12, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)