NCT06362109

Brief Summary

This is a prospective, randomized controlled clinical trail involved Elderly Patients With Dysphagia.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding in Elderly Patients With Dysphagia. The main questions it aims to answer: Can Intermittent Nutritional Tube Supplementation help improve the nutritional status in Elderly Patients With Dysphagia. Participants will be divided into two groups randomly. All patients are given routine rehabilitation and the intervention group is given Intermittent Oro-esophageal Tube Feeding once a day.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

April 8, 2024

Last Update Submit

April 11, 2024

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

  • Nutritional status-prealbumin

    The relevant indicators include prealbumin (PA, mg/L) from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach ones and in the morning.

    Day 1 and day 15

Secondary Outcomes (2)

  • Nutritional status-albumin

    Day 1 and day 15

  • Nutritional status-hemoglobin

    Day 1 and day 15

Study Arms (2)

Routine rehabilitation group

ACTIVE COMPARATOR

This group is going to receive Routine rehabilitation once a day.

Behavioral: Routine rehabilitation

Routine rehabilitation + Intermittent Oro-esophageal Tube Feeding group

EXPERIMENTAL

This group is going to receive Routine rehabilitation once a day and Intermittent Oro-esophageal Tube Feeding once a day.

Behavioral: Routine rehabilitationDevice: Intermittent Oro-esophageal Tube Feeding

Interventions

Routine rehabilitationBEHAVIORAL

Routine rehabilitation consists of: 1. Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. 2. Swallowing training, including lemon ice stimulation, empty swallowing training, and pronunciation training. 3. Pulmonary function training, including standing training, cough training, and diaphragm muscle training.

Routine rehabilitation + Intermittent Oro-esophageal Tube Feeding groupRoutine rehabilitation group
Intermittent Oro-esophageal Tube FeedingDEVICE

The group is given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure: Before each feeding, inside and outside of the tube was cleaned with water. During feeding, the patient should maintain a semi-reclining or sitting position with mouth opened, and the tube was inserted slowly and smoothly into the upper part of the esophagus by medical staffs while the appropriate depth of intubation was checked with the calibration markings on the tube wall. The distance from the incisors to the head part of the tube should be between 22-25 cm.

Routine rehabilitation + Intermittent Oro-esophageal Tube Feeding group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\>60 years.
  • Dysphagia confirmed by Videofluoroscopic Swallowing Study.
  • Clear consciousness.
  • Stable vital signs.

You may not qualify if:

  • Complicated with severe liver and kidney failure, tumors, or hematological disorders.
  • Simultaneously in need to undergo other therapy that might affect the outcomes of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Louis Wi

    Site Coordinator of United Medical Group located in Miami

    STUDY CHAIR

Central Study Contacts

Laviena Ce

CONTACT

15422548954linchuangzhuce@126.com

Wei Zhao

CONTACT

13303321354zwjww2009@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

April 8, 2024

First Posted

April 12, 2024

Study Start

April 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

April 12, 2024

Record last verified: 2024-04