Status:
WITHDRAWN
Outcomes of Using LNMES on Tracheostomized Children
Lead Sponsor:
Children's Hospital Los Angeles
Conditions:
Trachea
Eligibility:
All Genders
30-5 years
Phase:
NA
Brief Summary
Tracheostomy tubes are known to have a negative impact on swallowing. Dysphagia treatment includes using laryngoneuromuscular electrical muscular stimulation (LNMES). Evidence exist on the efficacy of...
Eligibility Criteria
Inclusion
- PATIENT COHORT
- Children between 0-4 years 11 months
- Currently have tracheostomy tubes
- MBSS must indicate penetrations of more than 50% of swallows or aspiration of thin, ½ nectar-thick, nectar-thick or honey-thick liquids.
- The child must be on a modified diet of honey-thick liquids, nectar-thick liquids, ½ nectar-thick liquids, or no liquids by mouth.
- Able to tolerate a voice valve PARENT COHORT
- At least one primary caregiver of a qualifying child (see Child cohort).
- Parent/caregiver must be at least 18 years of age or older, provide primary care, and have medical decision making rights for the child.
Exclusion
- PATIENT COHORT
- Children who are not on modified diets or using a g-tube as an alternate means of nutrition
- Children with suspected or diagnosed heart problems
- Children with suspected or diagnosed epilepsy
- Children with a tendency to hemorrhage following acute trauma or fracture
- Children who have undergone recent surgical procedures when muscle contraction may disrupt the healing process
- Children for whom the LNMES would be: 1) over carotid sinus, 2) over neoplasm, 3) over active infection and 4) over areas of skin which lack normal sensation
- Children with difficulty tolerating tactile stimulation and tolerate the whole duration of the LNMES sessions.
- Children with difficulty tolerating tactile sensory stimulation such as tape and electrodes on the anterior aspect of the neck.
- PARENT COHORT
- The caregiver that does not provide the primary care of the child and does not have medical decision making right
- Parents under 18
Key Trial Info
Start Date :
May 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03227627
Start Date
May 1 2017
End Date
May 1 2020
Last Update
November 15 2024
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