UMIN-CTR Clinical Trial

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/ctr_e/ctr_view.cgi?recptno=R000046003

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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