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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027671
Receipt No. R000031406
Scientific Title Accuracy of pulse-oximetry under INTELLiVENT-ASV
Date of disclosure of the study information 2017/06/09
Last modified on 2018/12/07

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Basic information
Public title Accuracy of pulse-oximetry under INTELLiVENT-ASV
Acronym Accuracy of SpO2 under i-ASV
Scientific Title Accuracy of pulse-oximetry under INTELLiVENT-ASV
Scientific Title:Acronym Accuracy of SpO2 under i-ASV
Region
Japan

Condition
Condition Critically ill patients under mechanical ventilation
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 INTLLiVENT-ASV (available on Hamilton G5) is a closed-loop ventilatory mode that provides adequate ventilatory support by using patient information. In this ventilation mode, for example, FIO2 and PEEP are automatically adjusted according to the value of patient's SpO2. There are some reports, however, that the value of SpO2 sometimes dissociates from SaO2 among various critically ill states. Therefore, accuracy of SpO2 is a prerequisite to use this mode, but to date, there is no study to evaluate the accuracy of SpO2 (Hamilton G5) among various critically ill states.
In this study, we aim to evaluate the accuracy of SpO2 by measuring three commercially available products (Hamilton G5, Masimo and NIHON-KODEN) and comparing with SpO2.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Accuracy between SpO2 and SaO2
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 were eligible for enrollment if they were 20 years or older, required mechanical ventilation and admitted to the ICU
Key exclusion criteria 1. patients who can not measure pulse oximeter with fingers.
2. in case of an unreliable pulsatile SpO2 curve
3. patients who are under 20 years old.
4. patients who can not obtain the consent.
5. patients who undergo extracorporeal membrane oxygenation.
6 patients if carboxyhemoglobin (COHb) levels were > 3% or methemoglobin (MetHb) > 1.5%
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name SHINSHU KATAYAMA
Organization Jichi Medical University School of Medicine
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code
Address 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan
TEL 0285-58-7392
Email shinsyu_k@jichi.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name SHINSHU KATAYAMA
Organization Jichi Medical University School of Medicine
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code
Address 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan
TEL 0285-58-7392
Homepage URL
Email shinsyu_k@jichi.ac.jp

Sponsor
Institute Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2017 Year 06 Month 09 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
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
2017 Year 06 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Not applicable

Management information
Registered date
2017 Year 06 Month 07 Day
Last modified on
2018 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031406

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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