UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027671 |
|---|---|
| Receipt number | R000031406 |
| Scientific Title | Accuracy of pulse-oximetry under INTELLiVENT-ASV |
| Date of disclosure of the study information | 2017/06/09 |
| Last modified on | 2021/04/28 16:51:56 |
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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
Name of lead principal investigator
| 1st name | SHINSHU |
| Middle name | |
| Last name | KATAYAMA |
Organization
Jichi Medical University School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan
TEL
0285-58-7392
shinsyu_k@jichi.ac.jp
Public contact
Name of contact person
| 1st name | SHINSHU |
| Middle name | |
| Last name | KATAYAMA |
Organization
Jichi Medical University School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan
TEL
0285-58-7392
Homepage URL
shinsyu_k@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
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
Department of Anesthesiology and Intensive Care Medicine, Jichi Medical University School of Medicine
Address
3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan
Tel
0285-58-7392
shinsyu_k@jichi.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
| 2017 | Year | 06 | Month | 09 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41598-021-88608-7
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-021-88608-7
Number of participants that the trial has enrolled
100
Results
Mean SaO2 values, Nihon Kohden SpO2, and Masimo SpO2 were 95.7%, 96.4%, and 96.9%, respectively. The Nihon Kohden SpO2 were less biased than Masimo measurements; their precision was not significantly different. Nihon Kohden and Masimo SpO2 were not significantly different in the SaO2 < 94% group (P = 0.083). In the 94% <= SaO2 < 98% and SaO2 >= 98% groups, there were significant differences between the Nihon Kohden and Masimo SpO2 (P < 0.0001; P = 0.006; respectively).
Results date posted
| 2021 | Year | 04 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients were eligible for enrolment if they were >= 20 years old and ventilated with a G5 during their ICU stay. The exclusion criteria were age < 20 years, quality index of Nihon Kohden SpO2<= 60%, an unstable value of SpO2 due to change in FIO2 just before the blood sample was drawn, lack of SpO2 data, and a history of management with veno-arterial extracorporeal membrane oxygenation. In addition, patients with a difference of >10% in SpO2 and SaO2 values were excluded due to the possibility of outliers. For validation purposes, we added the analysis of the raw data, including data of the possible outliers.
Participant flow
Patients who were ventilated with a G5 ventilator (Hamilton Medical AG, Switzerland) in the ICU were included in this study.
Adverse events
No adverse events
Outcome measures
Patient baseline characteristics, including age, sex, height, body weight, body mass index, disease classifica- tion, and the use of veno-venous extracorporeal membrane oxygenation, were collected from electronic medi- cal records. In addition, the results of blood gas analyses, including pH, PaO2, arterial carbon dioxide tension, haemoglobin, and SaO2 values, were recorded. Furthermore, the PaO2/FIO2 ratio and severity of hypoxaemia were determined. Underlying medical histories were obtained, including information on hypertension, ischaemic heart disease, chronic heart failure, chronic obstructive pulmonary disease, cerebrovascular accidents, diabetes mellitus, and chronic kidney disease requiring haemodialysis. The Acute Physiology and Chronic Health Evalu- ation II19 was used to assess organ dysfunction. ICU stays and mechanical ventilation durations were evaluated. In addition, ICU and hospital mortality rates were assessed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 15 | Day |
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
| 2021 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031406
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