UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048039 |
|---|---|
| Receipt number | R000054754 |
| Scientific Title | Observational study of communication using electrolarynx for mechanically ventilated patients |
| Date of disclosure of the study information | 2022/06/13 |
| Last modified on | 2025/05/14 10:07:05 |
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Basic information
Public title
Observational study of communication using electrolarynx for mechanically ventilated patients
Acronym
Observational study of communication using electrolarynx for mechanically ventilated patients
Scientific Title
Observational study of communication using electrolarynx for mechanically ventilated patients
Scientific Title:Acronym
Observational study of communication using electrolarynx for mechanically ventilated patients
Region
| Japan |
Condition
Condition
Tracheostomized patients on mechanical ventilation
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the sounds of the hands-free electrolarynx compared to the conventional artificial larynx.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Speech intelligibility of hands-free electrolarynx
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Japanese patients aged 20 years or older who were receiving mechanical ventilation and had undergone tracheostomy in the intensive care unit.
2.Japanese patients who are expected to have difficulty weaning early from ventilation.
3.Japanese patients who are capable of communication; and provided informed consent to participate.
Key exclusion criteria
1.patients with neurological disorders.
2.pateients who had undergone maxillofacial or head and neck surgery with surgical wounds or anatomical abnormalities in the neck or oral cavity that could impede device placement.
3.patients with cognitive impairment, delirium, or agitation that made device placement difficult.
4.patients with very severe frailty or depressive symptoms who were deemed unsuitable for the study by the research staff.
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Sato |
Organization
Kanazawa University Hospital
Division name
Intensive Care Unit
Zip code
9208641
Address
Takara-machi 13-1, Kanazawa city, Ishikawa
TEL
0762652961
ksato@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Sato |
Organization
Kanazawa Uinversity Hospital
Division name
Intensive Care Unit
Zip code
9208641
Address
Takara-machi 13-1, Kanazawa city, Ishikawa
TEL
0762652961
Homepage URL
ksato@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa University Medical Ethics Review Committee
Address
Takara-machi 13-1, kanazawa, Ishikawa
Tel
076-265-2110
rinri@adm.kanazawa-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
7
Results
Most participants were male (male: n=6), with four admitted for respiratory diseases. The median age was 69 years. The median EES for the hands-free electrolarynx was 3.5. When a research team member operated the conventional electrolarynx, the median EES was 4, showing no significant difference compared with the hands-free electrolarynx. When patients operated a conventional artificial larynx themselves, the median EES score decreased to 2, a significantly lower score than with the hands-free type.
Results date posted
| 2025 | Year | 05 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After obtaining informed consent, an orientation to the electrolarynx (conventional and hands-free electrolarynx) is provided. The intelligibility of the electronic voice is then assessed. Speech produced with the conventional electrolarynx is assessed first, followed by speech produced with the hands-free electrolarynx. For the conventional electrolarynx, participants are assessed in two conditions: one in which they are assisted by the research team, and another in which they hold the device and vocalize independently.
Management information
Registered date
| 2022 | Year | 06 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054754
