UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047793 |
|---|---|
| Receipt number | 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 | 2023/09/18 16:53:01 |
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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 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
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
tasuica@gmail.com
Sponsor or person
Institute
Chiba Emergency Medical Center
Institute
Department
Personal name
Funding Source
Organization
Chiba Emergency Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
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
千葉県救急医療センター（千葉県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
14
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
Main results already published
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
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 30 | Day |
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
| 2023 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054491
