UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023605
Receipt No. R000026890
Scientific Title Evaluation of the influence of environmental sound level and respiratory rate to accuracy of acoustic respiratory rate monitoring
Date of disclosure of the study information 2016/09/01
Last modified on 2016/08/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of the influence of environmental sound level and respiratory rate to accuracy of acoustic respiratory rate monitoring
Acronym Evaluation of the influence of environmental sound level and respiratory rate to accuracy of acoustic respiratory rate monitoring
Scientific Title Evaluation of the influence of environmental sound level and respiratory rate to accuracy of acoustic respiratory rate monitoring
Scientific Title:Acronym Evaluation of the influence of environmental sound level and respiratory rate to accuracy of acoustic respiratory rate monitoring
Region
Japan

Condition
Condition Healthy
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 RRa utilizes acoustic technology to detect vibratory sounds originating in the walls of the large airways during breathing and transforms the sounds into an electrical signal that is converted into a numerical measurement that corresponds to a respiratory rate. Accuracy and precision of RRa was already reported. However, phonation or large sound around the sensor causes to display improper value respiratory rate. No previous report has investigated the threshold minimum of environmental noise level, which impedes accurate RRa monitoring. The purpose of this study is to evaluate the influence of environmental noise generated by forced-air warming system, which is widely used in operating rooms and intensive care unit, to respiratory rate monitoring by RRa in healthy volunteers.
Basic objectives2 Others
Basic objectives -Others The purpose of this study is to evaluate the influence of environmental noise generated by forced-air warming system, which is widely used in operating rooms and intensive care unit, to respiratory rate monitoring by RRa in healthy volunteers.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Each volunteer quietly lied down a bed in a quiet separated room An adhesive sensor integrated acoustic transducer was attached to his or her neck and pulse oximeter was attached on the right index finger. The aforementioned sensors were connected to the RRa monitoring system, and an observer confirmed the steady respiratory signal on the display of the RRa monitor for ten minutes. At the same time, another observer checked respiratory rate counting chest wall movements. A supervisor confirmed the each data of respiratory rate from RRa and counting chest wall movements at each occasion. The volunteer breathed at randomly indicated respiratory rate of 6, 12 and 30/min according to modified Early Warning Score. The volunteer maintained the constant breathing rhythm by referring to a second hand of a clock. Sound level was measured with an accurate sound level meter, and ambient sound level of the room under no audible sound was 45-55 dB. The noise around the neck sensor was generated by a forced-air warming system and the noise level was changed by following four steps of adjusting the distance between the nozzle of a forced-air warming system and the neck sensor; 45-55dB (no sound); 56-65dB (35-50 cm); 66-75dB (20-35 cm); and 76-85dB(10-20 cm). Thus, all volunteers performed 12 settings, including 3 patterns of respiratory rate and 4 sound levels. In each setting, respiratory rate was measured by an observer manually counting chest wall movements and RRa by another observer and repeated consecutive 3 min. Mean respiratory rate for the 3 min by the manual counting and RRa was recorded. RRa over 20% of the indicated respiratory rate for 15 sec or more was considered incorrect value and the other was considered correct value.
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 Healthy volunteers of ASA-PS (American Society of Anesthesiolosists-Physical Status)1 or 2
Key exclusion criteria (1) Volunteers of >ASA-PS 3
(2)A minor
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Toyama
Organization Tohoku University Hospital
Division name Department of Anesthesiology
Zip code
Address Department of Anesthesiology, Tohoku University Hospital, 1-1 Seiryomachi, Aoba-ku, Sendai
TEL +81-22-717-7321
Email h-toyama@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shizuha Yabuki
Organization Tohoku University Hospital
Division name Department of Anesthesiology
Zip code
Address Department of Anesthesiology, Tohoku University Hospital, 1-1 Seiryomachi, Aoba-ku, Sendai
TEL +81-22-717-7321
Homepage URL
Email yabuki-thk@umin.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Tohoku University
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 09 Month 01 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 Completed
Date of protocol fixation
2016 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Each volunteer quietly lied down a bed in a quiet separated room An adhesive sensor integrated acoustic transducer was attached to his or her neck and pulse oximeter was attached on the right index finger. The aforementioned sensors were connected to the RRa monitoring system, and an observer confirmed the steady respiratory signal on the display of the RRa monitor for ten minutes. At the same time, another observer checked respiratory rate counting chest wall movements. A supervisor confirmed the each data of respiratory rate from RRa and counting chest wall movements at each occasion. The volunteer breathed at randomly indicated respiratory rate of 6, 12 and 30/min according to modified Early Warning Score. The volunteer maintained the constant breathing rhythm by referring to a second hand of a clock. Sound level was measured with an accurate sound level meter, and ambient sound level of the room under no audible sound was 45-55 dB. The noise around the neck sensor was generated by a forced-air warming system and the noise level was changed by following four steps of adjusting the distance between the nozzle of a forced-air warming system and the neck sensor; 45-55dB (no sound); 56-65dB (35-50 cm); 66-75dB (20-35 cm); and 76-85dB(10-20 cm). Thus, all volunteers performed 12 settings, including 3 patterns of respiratory rate and 4 sound levels. In each setting, respiratory rate was measured by an observer manually counting chest wall movements and RRa by another observer and repeated consecutive 3 min. Mean respiratory rate for the 3 min by the manual counting and RRa was recorded. RRa over 20% of the indicated respiratory rate for 15 sec or more was considered incorrect value and the other was considered correct value.

Management information
Registered date
2016 Year 08 Month 12 Day
Last modified on
2016 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026890

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.