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Aspiration PneumoniaNCT05810688

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

A study testing eating rehabilitation training in people with Aspiration Pneumonia, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 75 to 110 yearsHealthy volunteers can take part
Conditions the study is for
Aspiration Pneumonia
What is being tested?
eating rehabilitation training
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteTaiwan
Study dates
21 Feb 2023to 20 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 to 110 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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%

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Tase Jyy Wang, PhD contact

886-911246130

tasejyy@ntunhs.edu.tw

Ling Yi Tai contact

Taiwan1 site, 1 recruiting

  • Taipei Veterans General Hospital

    Taipei

    Tai Ling-Yi

    Recruiting

Other trials in Taiwan

About this study

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.

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.

Read the 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.

Being tested
eating rehabilitation training
Keywords
elderly, Aspiration Pneumonia, eating rehabilitation training, removal of nasogastric tube
Medical subject headings
Pneumonia, Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05810688
Study groupRoleWhat they receive
Eating rehabilitation training groupExperimentalThe intervention group will receive eating rehabilitation training, including oral care, saliva gland massage, oral exercise, feeding strategy, and swallowing skill education
Receives: Other: eating rehabilitation training
Control groupNo interventionThe control group will receive only usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From date of randomization until the date of discharge from the cause, assessed up to one month.

Secondary outcomes (1)

  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2023
  2. Study start21 Feb 2023
  3. Primary completion20 Feb 2024 (estimated)
  4. Study completion20 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05810688
Sponsor's protocol ID
TPEVGH 2023-01-005AC
Status last verified
Mar 2023
First submitted
19 Mar 2023
Last updated
12 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34273953

  • 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.

    PubMed 34087608

  • 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.

    PubMed 27785002

  • 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.

    PubMed 33936197

  • 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.

    PubMed 35028056

Questions about this trial

What is this clinical trial studying?

A study testing eating rehabilitation training in people with Aspiration Pneumonia, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tase Jyy Wang, PhD (886-911246130, tasejyy@ntunhs.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

nasogastric tube successfully removed and spent of time with removed successfully nasogastric tube (time frame: From date of randomization until the date of discharge from the cause, assessed up to one month.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05810688, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.

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