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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047793
Receipt No. R000054491
Scientific Title Assessments of respiration with non-contact vital sign monitor in mechanically ventilated patients in intensive care unit: A prospective exploratory observational study
Date of disclosure of the study information 2022/05/18
Last modified on 2022/05/18

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Basic information
Public title Assessments of respiration with non-contact vital sign monitor in mechanically ventilated patients in intensive care unit: A prospective exploratory observational study
Acronym non-contact respiratory monitor in ICU patients
Scientific Title Assessments of respiration with non-contact vital sign monitor in mechanically ventilated patients in intensive care unit: A prospective exploratory observational study
Scientific Title:Acronym non-contact respiratory monitor in ICU patients
Region
Japan

Condition
Condition mechanically ventilated patients in intensive care unit
Classification by specialty
Anesthesiology Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess whether respiratory-related tidal weight change and frequency caused by shifts of the abdominal visceral organs along the long axis of the bed load cells under the bed legs during respiration reflect mechanical ventilation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes respiratory-related tidal weight change measured by load cells under the bed legs
Key secondary outcomes respiratory-related tidal weight change frequency measured by load cells under the bed legs, tidal volume, respiratory rate

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 Adult patients receiving mechanical ventilation under tracheal intubation in ICU
Key exclusion criteria 1. Patients treated by artificial organs other than respirator
2. Patients rested on a bed which the load cells are unable to be placed.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name AZUSA
Middle name
Last name INADA
Organization Chiba Emergency Medical Center
Division name Anesthesia
Zip code 261-0012
Address 3-32-1 Isobe Mihama-ku, Chiba city, Chiba, Japan
TEL 047-355-2101
Email tasuica@gmail.com

Public contact
Name of contact person
1st name AZUSA
Middle name
Last name INADA
Organization Chiba Emergency Medical Center
Division name Anesthesia
Zip code 261-0012
Address 3-32-1 Isobe Mihama-ku, Chiba city, Chiba, Japan
TEL 047-355-2101
Homepage URL
Email tasuica@gmail.com

Sponsor
Institute Chiba Emergency Medical Center
Institute
Department

Funding Source
Organization Chiba Emergency Medical Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Anesthesiology, Graduate school of Medicine, Chiba University
Name of secondary funder(s) MinebeaMitsumi Inc..

IRB Contact (For public release)
Organization Chiba Emergency Medical Center
Address 3-32-1 Isobe Mihama-ku, Chiba city, Chiba, Japan
Tel 043-279-2211
Email tasuica@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
2022 Year 05 Month 18 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
2022 Year 05 Month 02 Day
Date of IRB
2022 Year 05 Month 13 Day
Anticipated trial start date
2022 Year 05 Month 19 Day
Last follow-up date
2022 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We previously reported that four load cells placed under the bed legs successfully captured a centroid shift during spontaneous respiration in human subjects lying on a bed without contact and constraint (J Appl Physiol 2019).

In this observational study, we aimed to test whether respiratory-related tidal weight changes (primary variable) and frequency (secondary variable) measured by the load cells placed under the bed-legs in patients treated with mechanical ventilation accurately reflect tidal volume and respiratory frequency, respectively, measured by the respiratory flow meter with a built-in ventilator.

For 15 patients with mechanical ventilation, four load cell sensors are installed under the bed legs for measurements of vital signs obtained by the load cell signals. Four load cell sensors are non-contact, non-invasive, and electrically safe for the patients. Except for the installation of the sensors, patients will be treated routinely in our hospital without any restrictions and invasive interventions in this study.

For patients in the intensive care unit who require mechanical ventilation management, after obtaining the consent of the patient's family, a bed sensor will be installed and non-contact respiratory status measurement will be started.

After installation, carry out continuous measurement for 48 hours or more including the time of 14:00. Data of respiratory status measured in the ventilator, such as ventilator settings and tidal volume at the same time as measured by the bed sensor, is extracted from the respiratory patient monitoring system. We will compare and examine the data of respiratory status measured by the bed sensor system and the ventilator.

Management information
Registered date
2022 Year 05 Month 18 Day
Last modified on
2022 Year 05 Month 18 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054491

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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