UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051099 |
|---|---|
| Receipt number | R000054359 |
| Scientific Title | Outcomes of patients receiving percutaneous cricothyrotomy: An observational study |
| Date of disclosure of the study information | 2023/05/18 |
| Last modified on | 2023/11/17 22:28:53 |
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Basic information
Public title
Outcomes of patients receiving percutaneous cricothyrotomy: An observational study
Acronym
Outcomes of patients receiving percutaneous cricothyrotomy
Scientific Title
Outcomes of patients receiving percutaneous cricothyrotomy: An observational study
Scientific Title:Acronym
Outcomes of patients receiving percutaneous cricothyrotomy
Region
| Japan |
Condition
Condition
Patients who received percutaneous cricothyrotomy
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of outcomes of patients received cricothyrotomy by Selzinger method
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of device use
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing cricothyrotomy in ICU/HCU
Key exclusion criteria
Patients whose procedures were performed by a physician other than an anesthesiologist
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Yokose |
Organization
Yokohama City University Hospital
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
2360004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
+81457872800
yokose_p12@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Yokose |
Organization
Yokohama City University Hospital
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
2360004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
+81457872800
Homepage URL
yokose_p12@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The institutional ethics committee of Yokohama city university hospital
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel
+81457872800
rinri@yokohama-cu.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
| 2023 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
81
Results
Results date posted
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collect the following information from the electronic medical record
1) age, sex, height, weight, weight change, history of smoking, past history, comorbidity, type of surgical procedure, SOFA score, APACHE II, duration of tracheal intubation
2) detail of the SBT, GCS, JCS, amount of intratracheal sputum
3) WBC, Hb, Plt, TP, serum albumin, total bill, AST, ALT, LDH, CRP. ALP, gamma GTP, BUN, creatinine, BS, PT-INR, APTT
4) Complications and side effects and their description
5) outcomes: duration of device placement, replacement after removed of the device, transition of tracheostomy, length of stay in ICU, length of hospital stay, ventilator free days, discharge/transfer/death, complications after discharge to general ward,
Analysis of primary outcome
Median and interquartile range for duration of device placement
Analysis of secondary outcome
Frequency (percentage) and median (interquartile range) for each parameter. The same evaluation is performed for the subgroups in the duration of device placement.
Exploring factors associated with length of device placement
Multiple regression analysis is performed on factors expected to be related, with the length of device placement as the independent variable. (age, sex, height, weight, SOFA, APACHE II, weight change, Presence of impaired consciousness, number of days the patient was intubated, RSBI, maximal inspiratory pressure, presence of one or more acute complications (reintubation, complications at insertion: bleeding, extratracheal insertion, vertical and subcutaneous emphysema, blood phlegm [lasting more than 1 day, airway obstruction])
Management information
Registered date
| 2023 | Year | 05 | Month | 18 | Day |
Last modified on
| 2023 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054359
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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