UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000040319
Receipt No. R000046003
Scientific Title An observational study to determine the risk factor for unplanned extubation or removal of catheter in the intensive care unit
Date of disclosure of the study information 2020/05/07
Last modified on 2020/08/27 (Ver. 3)

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Basic information
Public title An observational study to determine the risk factor for unplanned extubation or removal of catheter in the intensive care unit
Acronym An observational study to determine the risk factor for unplanned extubation or removal of catheter in the intensive care unit
Scientific Title An observational study to determine the risk factor for unplanned extubation or removal of catheter in the intensive care unit
Scientific Title:Acronym An observational study to determine the risk factor for unplanned extubation or removal of catheter in the intensive care unit
Region
Japan

Condition
Condition Mechanically ventilated patients
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the risk factor of risk events.
Basic objectives2 Others
Basic objectives -Others To evaluate Intentional movements, CAM-ICU, RASS, BPS, and days after ICU admission as risk factors of risk events.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence and frequency of risk and the frequency of intentional movements
Key secondary outcomes The incidence and frequency of risk and CAM-ICU, RASS, BPS, days after ICU admission

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Mechanically ill patients managed by analgesia and sedation protcol
Key exclusion criteria We excluded patients whose RASS is more than or equal to 3.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Nobuto
Middle name
Last name Nakanishi
Organization Tokushima university hospital
Division name Emergency and Critical Care Medicine
Zip code 770-8503
Address Tokushima
TEL 0886339347
Email nobuto_nakanishi@yahoo.co.jp

Public contact
Name of contact person
1st name Nobuto
Middle name
Last name Nakanishi
Organization Tokushima university hospital
Division name Emergency and Critical Care Medicine
Zip code 770-0037
Address 2-50-1, Kuramoto, Tokushima 770-8503, Japan
TEL 08016010115
Homepage URL
Email nobuto_nakanishi@yahoo.co.jp

Sponsor
Institute The university of Tokushima
Institute
Department

Funding Source
Organization The university of Tokushima
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokushima university hospital, ethics committee in nursing department
Address 2-50-1, Kuramoto, Tokushima 770-8503, Japan
Tel 088-631-3111
Email awachiken@tokushima-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
2020 Year 05 Month 07 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 82
Results 
Of the 82 patients enrolled, upper limb movements were observed in 49 (60%) patients with risk behaviors in 15 (18%) patients (Fig. 1a). There were 331 total movements with 27 (8%) risk movements such as grabbing the intubation tube (n=26) or catheter (n=1). No-risk movements were classified into reaction (n=268; 81%), expression (n=16; 5%), and activity (n=20; 6%).
Results date posted
2020 Year 08 Month 27 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
2016 Year 06 Month 01 Day
Date of IRB
2016 Year 03 Month 01 Day
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study: Evaluation of risk factors for risk events in mechanically ventilated patients.

Management information
Registered date
2020 Year 05 Month 07 Day
Last modified on
2020 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046003