UMIN-CTR Clinical Trial

Basic information
Public title	Assessments of perioperative respiratory pattern with non-contact vital sign monitor in children undergoing minor surgery: Exploratory observational study.
Acronym	Assessments of perioperative respiratory pattern with non-contact vital sign monitor in children undergoing surgery.
Scientific Title	Assessments of perioperative respiratory pattern with non-contact vital sign monitor in children undergoing minor surgery: Exploratory observational study.
Scientific Title:Acronym	Assessments of perioperative respiratory pattern with non-contact vital sign monitor in children undergoing surgery.
Region	Japan

Condition
Condition	Minor surgery for children including inguinal hernia, nevus of Ota, etc.
Classification by specialty	Surgery in general Pediatrics Anesthesiology Operative medicine Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Use a non-contact biometric monitor to test the hypothesis that a temporary decrease in respiratory rate is observed at rest in the hospital room after surgery, but recovers rapidly.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detect that the resting breathing rate immediately after surgery differs from 2 hours after surgery by 3-5 breaths / minute.
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	1 years-old <=
Age-upper limit	10 years-old >=
Gender	Male and Female
Key inclusion criteria	ASA-PS1 and 2 pediatric patients undergoing scheduled minor surgery under general anesthesia at Chiba University Hospital.
Key exclusion criteria	Emergency surgery, scheduled surgery for 3 hours or more, consent is not obtained.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Hateruma
Organization	Chiba University Hospital
Division name	Department of Anesthesia, Pain and Palliative Medicine
Zip code	260-8670
Address	1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL	043-222-7171(6771)
Email	aeua.yuki@gmail.com

Public contact
Name of contact person	1st name Yuki Middle name Last name Hateruma
Organization	Chiba University Hospital
Division name	Department of Anesthesia, Pain and Palliative Medicine
Zip code	260-8670
Address	1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL	043-222-7171(6771)
Homepage URL
Email	aeua.yuki@gmail.com

Sponsor
Institute	Ministry of Health, Labour and Welfare
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Chiba University Hospital
Address	1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel	043-222-7171(extension 6771)
Email	aeua.yuki@gmail.com

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	2021 Year 09 Month 29 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	Preinitiation
Date of protocol fixation	2021 Year 08 Month 23 Day
Date of IRB	2021 Year 08 Month 23 Day
Anticipated trial start date	2021 Year 09 Month 29 Day
Last follow-up date	2022 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Currently, there are no non-contact, continuous respiration measuring devices in children. Chiba University is developing a device that continuously measures biological information signals including respiratory from the signals of load cells installed under the legs of the bed in a non-invasive, unrestrained state without restricting the activity of the subject. In this study, we test the hypothesis that "a temporary decrease in respiratory rate (primary endpoint) is observed at rest in the hospital room after surgery, but it recovers quickly" by the sensor measurement.

Management information
Registered date	2021 Year 09 Month 27 Day
Last modified on	2021 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052039