UMIN-CTR Clinical Trial

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
Email	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
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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031406