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

Sponsor
National Taipei University of Nursing and Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05810688
Collaborator
Taipei Veterans General Hospital, Taiwan (Other)
96
1
2
12
8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: eating rehabilitation training
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
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.
Actual Study Start Date :
Feb 21, 2023
Anticipated Primary Completion Date :
Feb 20, 2024
Anticipated Study Completion Date :
Feb 20, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

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.

No Intervention: Control group

The control group will receive only usual care.

Outcome Measures

Primary Outcome Measures

  1. nasogastric tube successfully removed and spent of time with removed successfully nasogastric tube [From date of randomization until the date of discharge from the cause, assessed up to one month.]

    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

Secondary Outcome Measures

  1. The re-insertion rate after one month of NG removal [From the date of discharge from any cause, assessed up to one month.]

    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.

Other Outcome Measures

  1. 30 days unexpected re-admission rate. [From the date of discharge from any cause, assessed up to one month.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
75 Years to 110 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei Veterans General Hospital Taipei Taiwan

Sponsors and Collaborators

  • National Taipei University of Nursing and Health Sciences
  • Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Tase Jyy Wang, PhD, National Taipei University of Nursing and Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tsae Jyy, Wang, RN PhD professer, National Taipei University of Nursing and Health Sciences
ClinicalTrials.gov Identifier:
NCT05810688
Other Study ID Numbers:
  • TPEVGH 2023-01-005AC
First Posted:
Apr 12, 2023
Last Update Posted:
Apr 12, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tsae Jyy, Wang, RN PhD professer, National Taipei University of Nursing and Health Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2023